21 CFR Part 11

I work for a medicine manufacturing company. We use really complicated software that is really heavy when it comes to bandwidth because it is 21 CFR Part 11 compliant. Does anyone know if Adobe is also 21 CFR Part 11 compliant???

Try
http://solutionpartners.adobe.com/lifesciences/
http://solutionpartners.adobe.com/products/livecycle/

Similar Messages

Pharmaceuticals Best Practice - 21 CFR Part 11

I work for a SAP partner and our company would like to learn more about and provide support for 21 CFR Part 11 compliance - tracking changes and who made the changes. Do we need to have the pharmaceuticals best practice installed in our SAP installation, or can I simply just use the AUT01 - AUT10 transactions?
Any help / suggestions is appreciated
Kathleen

Hi Kathleen,
The trick with best practices is that you can use different building blocks from most best practices in other environmnents. U can use the configuration guide P45: Configuration Guide (http://help.sap.com/bp_pharmav1600/Pharma_US/HTML/business_support_EN_US.htm), by 'simply' following the steps in this guide.
Ofcourse there is a but, because you need to be sure that you implemented the right notes and baseline packages.
Hope I gave you some direction in where to look.
Kind regards,
Ruud

Any plan to support 21 CFR part 11?

If NI didn't support 21CFR part 11, I must change to another scada program.
Do you have any plan to support 21CFR part 11?

The following link might be helpful to you:
http://zone.ni.com/devzone/conceptd.nsf/webmain/EBEE1EF8B8111F2786256C0E00552DF2?opendocument
The same goes for Lookout. While it is not by itself compliant with 21 CFR Part 11 standards, it is a design tool that can be used to create an application that is 21 CFR Part 11 compliant.
I hope that helps.
Let me know if you have more questions.
Jaideep J
Applications Engineer
National Instruments Corp.

Pharma implementation USFDA ---21 CFR Part 11

Hi All,
Has anybody worked on Pharma implementation which includes entire software validation process including USFDA 21CFRPart11.
If yes please let me know what it is all about.
with regards,
Raghu

Hi,
we have implemented SAP in numerous accounts where FDA-regulated processes have been part of the project and therefore Part 11 applies.
If you have access to the <a href="http://www.sap.com/sapphire">SAPPHIRE</a> history, you can see some presentations about implementations at customers that include validation (in the FDA sense) of the implemented solution.
Probably the best introductory document is the Part 11 whitepaper which is available on www.sap.com :
<a href="http://download.sap.com/download.epd?context=350C36E2AD32CCFA36DC79DA781757790DDBF824DFC6C128F28E92887B5AC3CB2752FFF9D79B09F13CF74B15BC1C9720E039264EDF50383B">"Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry"</a>
In general, check out sap.com --> Industries --> Life Sciences. There is a lot of helpful information on compliance in general and 21 CFR Part 11 in particular.
i hope this helps....if so award my first points !!
Thanks.
Oliver

CFR part 11 and CUP

Hi Gurus,
Can you please let us know whether the CUP tool is CFR part 11 compliant?

Hi,
Since CUP has electronic signatures and electronic records, I hope it is complaint to CFR 11.
But, CFR Part 11 deals with majorly Food and Drug Administration (FDA) guidelines, which means it is a specific industry compliance. So not very sure
Check this link:
U.S. Food and Drug Administration (FDA) Title 21 Code of Federal Regulations (CFR) Part 11 [original link is broken]
Regards,
Raghu
Edited by: Raghu Boddu on Aug 3, 2011 7:20 AM

FDA validations and 21 CFR

HI Sap Gurus,
can anybody please provide me some FD validation documents and 21 CFR documents. I have interview on that for SAP MM position. Points will be awarded for helpful replies with documents and a brief idea
Thanks
Anusha

Hello!
I helped implement a compliance with 21 CFR Part 11. We added a history table for each table that held clinical data. Each history table carried all the fields for that table, plus fields for who made the change to the record, when the change was made, why the change was made, the process id that made the change, and related information for our site. That way we had everything and could query it for any reporting we needed.
Thanks Cecil for you information but I am hoping someone has an idea as to how to implement. Our concern as you pointed out is what else changes during an update, for example what other tables besides the one being updated are being touched.
If the interface we are using has one screen that updates more than 1 table all we can do is to record the reason for the change that would represent all the table(s) change inclusively. Thanks for the input.
Michael

FD validation and 21 CFR

HI Sap Gurus,
can anybody please provide me some FD validation documents and 21 CFR documents. I have interview on that for SAP MM position. Points will be awarded for helpful replies with documents and a brief idea
Thanks
Anusha

Hello!
I helped implement a compliance with 21 CFR Part 11. We added a history table for each table that held clinical data. Each history table carried all the fields for that table, plus fields for who made the change to the record, when the change was made, why the change was made, the process id that made the change, and related information for our site. That way we had everything and could query it for any reporting we needed.
Thanks Cecil for you information but I am hoping someone has an idea as to how to implement. Our concern as you pointed out is what else changes during an update, for example what other tables besides the one being updated are being touched.
If the interface we are using has one screen that updates more than 1 table all we can do is to record the reason for the change that would represent all the table(s) change inclusively. Thanks for the input.
Michael

How to handle the SQL Error: ORA-01704: string literal too long

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN">
<html>
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<title></title>
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HI please chek the query getting error like string literal too long update PRVDR_ENRLMNT_AGREEMENT B set b.terms=q'#
<div class="widget-title">
<h5>Medical Assistance Provider Enrollment & Trading Partner Agreement - Conditions:</h5>
<a href="# class="btn-minimize pull-right"></a></div>
<div class="widget-content">
<table width="100%" border="0">
<tbody>
<tr valign="center">
<td class="Label" align="left" width="14%" colspan="2" height="32">In applying for enrollment as a provider or trading partner in the Medical Assistance Program (and programs for which the Michigan Department of Community Health (MDCH) is the fiscal intermediary), I represent and certify as follows:</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">1.</td>
<td class="LabelValue" valign="top" align="left" height="32">The applicant, and the employer (if applicable), certify that the undersigned has/have the authority to execute this Agreement.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">2.</td>
<td class="LabelValue" valign="top" align="left" height="32">Enrollment in the Medical Assistance Program does not guarantee participation in MDCH managed care programs nor does it replace or negate the contract process between a managed care entity and its providers or subcontractors.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">3.</td>
<td class="LabelValue" valign="top" align="left" height="32">All information furnished on this Medical Assistance Provider Enrollment & Trading Partner Agreement form is true and complete.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">4.</td>
<td class="LabelValue" valign="top" align="left" height="32">The providers and fiscal agents of ownership and control information agree to provide proper disclosure of provider's owners and other persons criminal related to Medicare, Medicaid or Title XX involvement. [42 CFR 455.100]</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">5.</td>
<td class="LabelValue" align="left" height="32">The applicant and the employer agree to provide proper disclosure of any criminal convictions related to Medicare (Title XVIII), Medicaid (Title XIX), and other State Health Care Programs (Title V, Title XX, and Title XXI) involvement. [42 CFR 455.106 and 42 U.S.C. ? 1320a-7]</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">6.</td>
<td class="LabelValue" align="left" height="32">I agree to read the Medicaid Provider Manual from the Michigan Department of Community Health (MDCH). I also agree to comply with 1) the terms and conditions of participation noted in the manual, and 2) MDCH's policies and procedures for the Medical Assistance Program contained in the manual, provider bulletins and other program notifications.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">7.</td>
<td class="LabelValue" align="left" height="32">I agree to comply with the provisions of 42 CFR 455.104, 42 CFR 455.105, 42 CFR 431.107 and Act No. 280 of the Public Acts of 1939, as amended, which state the conditions and requirements under which participation in the Medical Assistance Program is allowed.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">8.</td>
<td class="LabelValue" align="left" height="32">I agree to comply with the requirements of Section 6032 of the Deficit Reduction Act of 2005, codified at section 1902 (a)(68) of the Social Security Act which relates to the conditions and requirements of "Employee Education About False Claims Recovery."</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">9.</td>
<td class="LabelValue" align="left" height="32">I agree that, upon request and at a reasonable time and place, I will allow authorized state or federal government agents to inspect, copy, and/or take any records I maintain pertaining to the delivery of goods and services to, or on behalf of, a Medical Assistance Program beneficiary. These records also include any service contract(s) I have with any billing agent/service or service bureau, billing consultant, or other healthcare provider.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">10.</td>
<td class="LabelValue" align="left" height="32">I agree to include a clause in any contract I enter into which allows authorized state or federal government agents access to the subcontractor's accounting records and other documents needed to verify the nature and extent of costs and services furnished under the contract.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">11.</td>
<td class="LabelValue" align="left" height="32">I understand that the incentive payment requested using my National Provider Identifier (NPI) number will be made directly to the Tax ID Number (TIN) that was indicated during the registration process.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">12.</td>
<td class="LabelValue" align="left" height="32">I am not currently suspended, terminated, or excluded from the Medical Assistance Program by any state or by the U.S. Department of Health and Human Services.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">13.</td>
<td class="LabelValue" align="left" height="32">I agree to comply with all policies and procedures of the Medical Assistance Program. I also agree that all disputes, including overpayments, may be adjudicated in administrative proceedings convened under Act No. 280 of the Public Acts of 1939, as amended, or in a court of competent jurisdiction. I further agree to reimburse the Medical Assistance Program for all overpayments, and I acknowledge that the Medicaid Audit System, which uses random sampling, is a reliable and acceptable method for determining such overpayments.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">14.</td>
<td class="LabelValue" align="left" height="32">I agree to comply with the privacy and confidentiality provisions of any applicable laws governing the use and disclosure of protected health information, including the privacy regulations adopted by the U.S. Department of Health and Human Services under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and Public Acts 104-191 (45 CFR Parts 160 and 164, Subparts A and E). I also agree to comply with the HIPAA security regulations, as applicable, for electronic protected health information by the compliance date, which is currently April 21, 2005 (45 CFR Parts 160 and 164, Subparts A and C).</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">15.</td>
<td class="LabelValue" align="left" height="32">This Agreement shall be governed by the laws of the State of Michigan and applicable federal law including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 (HIPAA).</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">16.</td>
<td class="LabelValue" align="left" height="32">The provisions of this Agreement are severable. If any provision is held or declared to be illegal, invalid or unenforceable, the remainder of the Agreement will continue in full force and effect as though the illegal, invalid or unenforceable provision had not been contained in this Agreement.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">17.</td>
<td class="LabelValue" align="left" height="32">Failure or delay on the part of either party to exercise any right, power, privilege, or remedy in this Agreement will not constitute a waiver. No provision of this Agreement may be waived by either party except in writing and signed by an authorized representative of the party requesting the waiver.</td>
</tr>
<tr valign="center">
<td class="Label" align="left" width="14%" colspan="2" height="32"></td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">18.</td>
<td class="LabelValue" align="left" height="32">If the nursing facility named on the Medical Assistance Provider Enrollment & Trading Partner Agreement is sold, the seller will notify MDCH of the sale at least ninety (90) days prior to the expected sale date. Further, it is understood that the sale will not be recognized for reimbursement purposes under the Medical Assistance Program until ninety (90) days after such notification. Provisions of 42 CFR 413.135(f) will be retrospectively satisfied at that time. Any exception must be approved in writing by MDCH. The new owner/provider must receive Medicare certification for all Medicaid-only beds in the facility within one year from the date of purchase of an operating nursing facility or from the date of reopening a previously closed nursing facility.</td>
</tr>
<tr valign="center">
<td class="Label" align="middle" width="14%" colspan="2" height="32">Medical Assistance Provider - Employer/Employee Conditions</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">19.</td>
<td class="LabelValue" align="left" height="32">The applicant is employed by the business listed, now referred to as the "employer", to provide Medical Assistance Program services to eligible beneficiaries at the service address listed.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">20.</td>
<td class="LabelValue" valign="top" align="left" height="32">The employer and the applicant shall advise MDCH within thirty (30) days after any change(s) in the employment relationship.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">21.</td>
<td class="LabelValue" align="left" height="32">The employer and the applicant agree to be jointly and severally liable for any overpayments billed and paid under Act No. 280 of the Public Acts of 1939, as amended, for services provided by the applicant to eligible beneficiaries.</td>
</tr>
<tr valign="center">
<td class="Label" align="middle" width="14%" colspan="2" height="32">Trading Partner Provisions</td>
</tr>
<tr valign="center">
<td class="Label" align="left" width="14%" colspan="2" height="32">The MDCH and its Trading Partner desire to facilitate the exchange of healthcare transactions ("Transactions") by electronically transmitting and receiving data in agreed formats in substitution for conventional paper-based documents.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">1.</td>
<td class="LabelValue" align="left" height="32">Companion Documents; Standards; Other Documentation. MDCH makes available certain inbound and outbound Electronic Data Interchange (EDI) transaction sets/formats and associated version. From time to time during the term of this Agreement, MDCH may modify supported transaction sets/formats. In submitting Transactions to MDCH, the Trading Partner agrees to conform to MDCH-issued provider publications and MDCH Companion Guides as amended from time to time. The MDCH Companion Guides, incorporated by reference herein, contain specific instructions for conducting each Transaction and as such supplement Implementation Guides issued under the Standards for Electronic Transactions mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as amended. The MDCH Companion Guides are not intended to be complete billing instructions and do not alter or replace applicable physician guides or other healthcare provider billing publications issued by MDCH or by other third party payers. The Trading Partner agrees to comply with the requirements set forth in the applicable MDCH Companion Guides. The Trading Partner, or its vendor, or other authorized technical representative responsible for EDI software will document Trading Partner Information, data formats and related versions, trading partner identifiers, and other information MDCH requires to receive and transmit specific Transactions supported by MDCH.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">2.</td>
<td class="LabelValue" align="left" height="32">Support. 
As to software, equipment, and services associated with each party's performance under this Agreement, the parties agree to provide support services sufficient for Transactions to be exchanged. Each party will assist the other in establishing and/or maintaining support procedures, and will complete appropriate problem determination procedures prior to contacting the other with a support related matter. The parties agree to use all commercially reasonable efforts to avoid and resolve performance and unavailability issues. Each party will perform remedial action, as requested by the other, to assist in problem resolution. Each party, at its own expense, shall provide and maintain the equipment, software, services, and testing necessary to effectively and reliably transmit and receive transactions.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">3.</td>
<td class="LabelValue" align="left" height="32">Data Retention. 
MDCH will log all Transactions for the purpose of problem investigation, resolution, and servicing. The Trading Partner is responsible for maintaining and retaining its own records of data submitted to MDCH. Trading Partners who are healthcare providers will ensure that electronic healthcare claims submitted to MDCH can be readily associated and identified with the correct patient medical and business office records, and that these records are maintained in a manner that permits review, and for the time period as may be required by MDCH or other third party payer responsible for claim payment.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">4.</td>
<td class="LabelValue" align="left" height="32">Proper Receipt and Verification for Transactions. 
Upon proper receipt of any ANSI ASC X12N Standard Transaction, the receiving party shall promptly and properly transmit a functional acknowledgement in return, unless otherwise specified. The functional and interchange acknowledgements must be accepted and reviewed, when applicable, to confirm the receipt of a Transaction. The ability to send or receive functional acknowledgements is applicable only to ANSI ASC X12N Standard Transactions. Additionally, MDCH originated outbound Transactions must be accepted and reviewed, when appropriate, to obtain MDCH's response to specific inbound Transactions. The acknowledging party does not attest to the accuracy of the data contained in the transmission; rather, it only confirms receipt of the transmission.</td>
</tr>
<tr valign="center">
<td class="Label" valign="top" nowrap align="right" width="1%" height="32">5.</td>
<td class="LabelValue" align="left" height="32">Liability. 
MDCH shall not be responsible to the Trading Partner nor anyone else for any damages caused by loss, delay, rejection, or any misadventure affecting such electronic information. In addition, MDCH shall be excused from performing any EDI servi

You cannot use string literal of more than 4000 characters in an Oracle SQL statement. I'm not going to count that string you so rudely posted but I presume it is longer than that figure. You'll need to use a variable instead.
declare
 c clob := '<your vast XML doc here>';
begin
 update PRVDR_ENRLMNT_AGREEMENT B set b.terms= c
 where ....
{code}
Cheers, APC

Need help with a popup window problem

I have this code within my certAppB.js page :
function AppSubmit() {
 str1 = "Submitting this form will begin the approval process.";
 str2 = "You will not be able to come back to this form to edit it again.";
 str3 = "Do you want to continue submitting this form?";
 if((confirm(str1 + "\n" + str2 + "\n" + str3))){
 document.forms[0].status.value="Submitted";
 document.forms[0].submit();
Which produces a popup windows that says:
Submitting this form will begin the approval process
You will not be able to come back to this form to edit it again
Do you want to continue submitting this form?
OK Cancel (these are 2 buttons)
I want to change this to say:
Submitting this form will begin the approval process. You will not be able to change this form once submitted. You also agree that the following statement is true and correct to the best of your knowledge and belief:
"I, [User Name], hereby certify and state on behalf of [Company Name] that the energy use data contained on this form are accurately determined and stated in accordance with federal test procedures set forth in 10 CFR Part 430 or 431, or 42U.S.C.�6314, as applicable, including authorized waivers, as they currently exist on [Date]."
Do you want to continue submitting this form?
OK Cancel
So I have to pull the users [User Name], [Company Name], and the [Date].
On the approverView.jsp login page ( which is the first login page users see after loggin) it shows
the users full name, so I nabbed the code from that page:
<body>
<jsp:include page="logo.jsp" />
<jsp:include page="unav-navigate.jsp" />
<table width="100%" border="0" cellspacing="0" cellpadding="5" class="info">
<tr>
<td width="25%" valign="top">
<logic:present name="UserContainer" property="userView" scope="session">
Welcome
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>
! 
</logic:present>
If you are not this person, please click <html:link styleClass="norm" href="/fake_name/logoff.do">here</html:link>.</td>
<td width="2%"> </td>
<td width="73%" valign="top"><jsp:include page="instruction.jsp" /></td>
</tr>
</table>
and made this code out of it to pull the username,companyname:
<logic:present name="UserContainer" property="userView" scope="session">
 User
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>
! 
</logic:present>
<logic:present name="UserContainer" property="userView" scope="session">
Company
 <bean:write name="UserContainer" property="userView.companyName" scope="session"/>
! 
</logic:present>
This is the userView.java page that is referanced :
* Created on Mar 28, 2003
* To change this generated comment go to
* Window>Preferences>Java>Code Generation>Code Template
package org.fake.name.view;
import java.io.Serializable;
import java.util.List;
import org.gama.cafs.businessobjects.TorqueDb;
* @author chris
public class UserView implements Serializable {
 private int userId;
 private int memberId;
 private int companyId;
 private String role;
 private String firstName;
 private String lastName;
 private String companyTitle;
 private String emailAddress;
 private String phoneNumber;
 private String companyName;
 private String address1;
 private String address2;
 private String address3;
 private String city;
 private String state;
 private String province;
 private String postalCode;
 private String countryName;
 private List productTypes = null;
 private List productTypeAcronyms = null;
 private List productTypeIds = null;
 private List tradeNameIds = null;
 private List tradeNames = null;
 private TorqueDb torqueDb = null;
 public UserView() { }
 * @return String
 public String getAddress1() {
 return address1;
 * @return String
 public String getAddress2() {
 return address2;
 * @return String
 public String getAddress3() {
 return address3;
 * @return String
 public String getCity() {
 return city;
 * @return String
 public String getCompanyName() {
 return companyName;
 * @return String
 public String getCompanyTitle() {
 return companyTitle;
 * @return String
 public String getCountryName() {
 return countryName;
 * @return String
 public String getEmailAddress() {
 return emailAddress;
 * @return String
 public String getFirstName() {
 return firstName;
 * @return String
 public String getLastName() {
 return lastName;
 * @return int
 public int getMemberId() {
 return memberId;
 * @return String
 public String getPhoneNumber() {
 return phoneNumber;
 * @return String
 public String getPostalCode() {
 return postalCode;
 * @return Set
 public List getProductTypes() {
 return productTypes;
 * @return String
 public String getProvince() {
 return province;
 * @return String
 public String getRole() {
 return role;
 * @return String
 public String getState() {
 return state;
 * @return int
 public int getUserId() {
 return userId;
 * Sets the address1.
 * @param address1 The address1 to set
 public void setAddress1(String address1) {
 this.address1 = trimString(address1);
 * Sets the address2.
 * @param address2 The address2 to set
 public void setAddress2(String address2) {
 this.address2 = trimString(address2);
 * Sets the address3.
 * @param address3 The address3 to set
 public void setAddress3(String address3) {
 this.address3 = trimString(address3);
 * Sets the city.
 * @param city The city to set
 public void setCity(String city) {
 this.city = trimString(city);
 * Sets the companyName.
 * @param companyName The companyName to set
 public void setCompanyName(String companyName) {
 this.companyName = trimString(companyName);
 * Sets the companyTitle.
 * @param companyTitle The companyTitle to set
 public void setCompanyTitle(String companyTitle) {
 this.companyTitle = trimString(companyTitle);
 * Sets the countryName.
 * @param countryName The countryName to set
 public void setCountryName(String countryName) {
 this.countryName = trimString(countryName);
 * Sets the emailAddress.
 * @param emailAddress The emailAddress to set
 public void setEmailAddress(String emailAddress) {
 this.emailAddress = trimString(emailAddress);
 * Sets the firstName.
 * @param firstName The firstName to set
 public void setFirstName(String firstName) {
 this.firstName = trimString(firstName);
 * Sets the lastName.
 * @param lastName The lastName to set
 public void setLastName(String lastName) {
 this.lastName = trimString(lastName);
 * Sets the memberId.
 * @param memberId The memberId to set
 public void setMemberId(int memberId) {
 this.memberId = memberId;
 * Sets the phoneNumber.
 * @param phoneNumber The phoneNumber to set
 public void setPhoneNumber(String phoneNumber) {
 this.phoneNumber = trimString(phoneNumber);
 * Sets the postalCode.
 * @param postalCode The postalCode to set
 public void setPostalCode(String postalCode) {
 this.postalCode = trimString(postalCode);
 * Sets the productTypes.
 * @param productTypes The productTypes to set
 public void setProductTypes(List productTypes) {
 this.productTypes = productTypes;
 * Sets the province.
 * @param province The province to set
 public void setProvince(String province) {
 this.province = trimString(province);
 * Sets the role.
 * @param role The role to set
 public void setRole(String role) {
 this.role = trimString(role);
 * Sets the state.
 * @param state The state to set
 public void setState(String state) {
 this.state = trimString(state);
 * Sets the userId.
 * @param userId The userId to set
 public void setUserId(int userId) {
 this.userId = userId;
 * @return List
 public List getProductTypeAcronyms() {
 return productTypeAcronyms;
 * Sets the productTypeIds.
 * @param productTypeIds The productTypeIds to set
 public void setProductTypeAcronyms(List productTypeAcronyms) {
 this.productTypeAcronyms = productTypeAcronyms;
 public List getProductTypeIds() {
 return productTypeIds;
 public void setProductTypeIds(List productTypeIds) {
 this.productTypeIds = productTypeIds;
 private String trimString(String str) {
 String tmp = null;
 if (str != null)
 tmp = str.trim();
 else
 tmp = str;
 return tmp;
 public List getTradeNameIds() {
 return tradeNameIds;
 public List getTradeNames() {
 return tradeNames;
 public void setTradeNameIds(List list) {
 tradeNameIds = list;
 public void setTradeNames(List list) {
 tradeNames = list;
 public TorqueDb getTorqueDb() {
 return torqueDb;
 public void setTorqueDb(TorqueDb db) {
 torqueDb = db;
 public int getCompanyId() {
 return companyId;
 public void setCompanyId(int i) {
 companyId = i;
Question:
How do I insert the code I assembled:
<logic:present name="UserContainer" property="userView" scope="session">
 User
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>
! 
</logic:present>
<logic:present name="UserContainer" property="userView" scope="session">
Company
 <bean:write name="UserContainer" property="userView.companyName" scope="session"/>
! 
</logic:present>
INTO the function:
function AppSubmit() {
 str1 = "Submitting this form will begin the approval process.";
 str2 = "You will not be able to come back to this form to edit it again.";
 str3 = "Do you want to continue submitting this form?";
 if((confirm(str1 + "\n" + str2 + "\n" + str3))){
 document.forms[0].status.value="Submitted";
 document.forms[0].submit();
So that the popup window will show the [username], [CompanyName], [Date]. I can�t find any doc�s on how to insert logic into a function with str�s.
Any help would be very much appreciated. Thanks in advance.
Applications used by me: Sun solaris 8 server, Tomcat 4.1.24, pulling from postgresql 7.3, and I edit in Eclipse 2.11.

These two tags:
<logic:present name="UserContainer" property="userView" scope="session">
</logic:present>
surround things you only want to happen if there is a userView object present.
This tag:
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
is replaced with the value of userView.getFirstName().
So:
<logic:present name="UserContainer" property="userView" scope="session">
 User
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>
! 
</logic:present>
becomes:
User Jim Steinberger !
if the userView object is present and firstName == Jim and lastName == Steinberger.
To insert those values into your JavaScript function:
<logic:present name="UserContainer" property="userView" scope="session">
function AppSubmit() {
str1 = "Submitting this form will begin the approval process.";
str2 = "You will not be able to come back to this form to edit it again.";
str3 = "You also agree that the following statement is true and correct to the best of your knowledge and belief:";
str4 = "";
str5 = "I, <bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>, hereby certify and state on behalf of <bean:write name="UserContainer" property="userView.companyName" scope="session"/> that the energy use data contained on this form are accurately determined and stated in accordance with federal test procedures set forth in 10 CFR Part 430 or 431, or 42U.S.C.?6314, as applicable, including authorized waivers, as they currently exist on " + new Date().getDate() + "/" + new Date().getMonth() + "/" + new Date().getFullYear() + ".";
str6 = "Do you want to continue submitting this form?";
if((confirm( str1 + "\n" + str2 + "\n" + str3 + "\n\n\n" + str4 + "\n" + str5 + "\n" + str6 ))){
document.forms[0].status.value="Submitted";
document.forms[0].submit();
</logic:present>
Should become:
function AppSubmit() {
str1 = "Submitting this form will begin the approval process.";
str2 = "You will not be able to come back to this form to edit it again.";
str3 = "You also agree that the following statement is true and correct to the best of your knowledge and belief:";
str4 = "I, Jim Steinberger, hereby certify and state on behalf of Dynamic Edge, Inc. that the energy use data contained on this form are accurately determined and stated in accordance with federal test procedures set forth in 10 CFR Part 430 or 431, or 42U.S.C.?6314, as applicable, including authorized waivers, as they currently exist on " + new Date().getDate() + "/" + new Date().getMonth() + "/" + new Date().getFullYear() + ".";
str6 = "Do you want to continue submitting this form?";
if((confirm( str1 + "\n" + str2 + "\n" + str3 + "\n\n" + str4 + "\n" + str5 + "\n\n" + str6 ))){
document.forms[0].status.value="Submitted";
document.forms[0].submit();
after being processed by Tomcat and Struts. (Note: the function will not appear if userView is missing)
By the way, you might be missing the closing bracket to function AppSubmit() { which might throw a JavaScript error. Just FYI :)
Good luck!
Jim Steinberger
[email protected]

Reducing file size without loosing clarity

I have two designs for labels that have to be approved by the government for type size regulations. The current size of the illustrator files are 133.3 MB and 24.7 MB I need to provide these at no larger than 450 kb AND the type must be readable and measurable for approval.
I have tried everything I can think of to provide the artwork small enough yet still retaining enough resolution to not make the type fuzzy and not able to be measured for size. I've tried making the files from within illustrator, I've tried taking everything into Photoshop to make the JPEGS with no luck. They want either a gif, jpeg or tiff no larger than 450 kb that is viewable at the print size of the label with no loss of resolution... Does anyone have any suggestions on how to create these?
Thanks in advance,
Nina

Photos, type gradients, complex paths, etc... and yes I know if they would just accept PDF files it would be no problem, but this is the Federal Government. Do they ever do anything the easiest way.
I think I figured out a way to get these down in size without lossing too much... I took the background with all the complex paths and I made a separate JPEG put that back into an illustrator file, placed the type over it and made an RGB JPEG out of illustrator...used the type hinting and a low setting. Got it down to 425 kb and well the type looks pretty darn good. I hope this works because I've done this well over a dozen times and they've all been rejected. This is the info the agency sent regarding it being rejected:
"Per Industry Circular 2011-4, your application and label(s) have not been reviewed for type size, characters per inch or contrasting background. The responsible industry member must continue to ensure that the mandatory information on the actual labels is displayed in the correct type size, number of characters per inch, and on a contrasting background in accordance with the TTB labeling regulations, 27 CFR parts 4, 5, 7, and 16, as applicable."
"One or more of your label images appear too small for the proper evaluation of your label(s). When the dimensions you specify are applied to the label, the system renders your label as a blurred image. Please remove the current image(s) and replace it with new, larger image(s). We advise that, when you develop your label images, the compression ratio should be set at MEDIUM or LOW so that the file is still within the file size limit of 450KB"
Thanks for your comment!

Digital signatures on SAP

Is there a way that digital signatures can be uploaded on SAP and that it can be encrypted so that it cannot be copied by anyone.

Thanks Garry,
I will surely wait for your further reply to get me the process of your 'open password' method. Can you help me in providing any link for guidance on compliance of SAP B1 with FDR 21 CFR part 11. I found some documents on sdn but they are for mySAP ERP and different modules of R/3. I didn't find any guide on B1 compliance with CFR part11.
Any reply from all users regarding my question is highly appreciated.
Regards,
Farhan

Electronic signature while approving documents

Dear experts,
I have a client who is validating its SAP B1 implemented system in compliance with FDA 21 CFR part 11 (electronic records and electronic signatures).
Can any one please describe how SAP business one treats electronic signature while approving documents? because in FDA 21 CFR part 11, it requires electronic signature on approval of certain documents which must contain 'the name of the signer, 'time and date stamp' and the 'meaning (such as approve, review, verify) associated with the signature' plus the traceable record of electronic signatures.
Furthermore, it also require a 'password' or user id of the signer' at the time of signing the document. In B1, it does not ask for user id / password at the time of approval and simply rely on login id / password. If user is already logged in, B1 simply allow the approver to approve a document and does not prompt for user id / password again.
Can we fulfill the signing requirement in SAP Business one? and modify or customize B1 in such a way that it starts prompting for user id / password at the time of approving the document too?
Any help is highly appreciated>
Thanks in advance,
Farhan

Closing it

Add-on for Quality

Hi
One of my client is implementing 21 CFR Part 820 and ISO 13485 QS standards in US. Please let me know if there are any add-ons available that will help facilitate implementation and provide management tools for both of these standards or the FDA 21 CFR Part 820 as a minimum.
Regards
Louis

Louis,
For these 2 Quality standards I do not think there is any specific AddOn. But I would say that to comply with these standards what ever is needed from the system mainly on the reporting side can be facilitated by configuration and through custom reports.
The ISO organization mainly validates standard on reporting and document maintenance and since I was involved on a few projects governed by ISO, I can say it is very much doable.
Any thing related to FDA mainly looks at tracability of an Item and how soon a Recall can me made on case of any quality issues.
When you have a Serial or Batch Managed Item, the Item can be easily traced to meet FDA's requirements.
Best wishes
Suda

Popup window problem in tomcat

I have this code within my certAppB.js page :
function AppSubmit() {
 str1 = "Submitting this form will begin the approval process.";
 str2 = "You will not be able to come back to this form to edit it again.";
 str3 = "Do you want to continue submitting this form?";
 if((confirm(str1 + "\n" + str2 + "\n" + str3))){
 document.forms[0].status.value="Submitted";
 document.forms[0].submit();
Which produces a popup windows that says:
Submitting this form will begin the approval process
You will not be able to come back to this form to edit it again
Do you want to continue submitting this form?
OK Cancel (these are 2 buttons)
I want to change this to say:
Submitting this form will begin the approval process. You will not be able to change this form once submitted. You also agree that the following statement is true and correct to the best of your knowledge and belief:
"I, [User Name], hereby certify and state on behalf of [Company Name] that the energy use data contained on this form are accurately determined and stated in accordance with federal test procedures set forth in 10 CFR Part 430 or 431, or 42U.S.C.�6314, as applicable, including authorized waivers, as they currently exist on [Date]."
Do you want to continue submitting this form?
OK Cancel
So I have to pull the users [User Name], [Company Name], and the [Date].
On the approverView.jsp login page ( which is the first login page users see after loggin) it shows
the users full name, so I nabbed the code from that page:
<body>
<jsp:include page="logo.jsp" />
<jsp:include page="unav-navigate.jsp" />
<table width="100%" border="0" cellspacing="0" cellpadding="5" class="info">
<tr>
<td width="25%" valign="top">
<logic:present name="UserContainer" property="userView" scope="session">
Welcome
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>
! 
</logic:present>
If you are not this person, please click <html:link styleClass="norm" href="/fake_name/logoff.do">here</html:link>.</td>
<td width="2%"> </td>
<td width="73%" valign="top"><jsp:include page="instruction.jsp" /></td>
</tr>
</table>
and made this code out of it to pull the username,companyname:
<logic:present name="UserContainer" property="userView" scope="session">
 User
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>
! 
</logic:present>
<logic:present name="UserContainer" property="userView" scope="session">
Company
 <bean:write name="UserContainer" property="userView.companyName" scope="session"/>
! 
</logic:present>
This is the userView.java page that is referanced :
* Created on Mar 28, 2003
* To change this generated comment go to
* Window>Preferences>Java>Code Generation>Code Template
package org.fake.name.view;
import java.io.Serializable;
import java.util.List;
import org.gama.cafs.businessobjects.TorqueDb;
* @author chris
public class UserView implements Serializable {
 private int userId;
 private int memberId;
 private int companyId;
 private String role;
 private String firstName;
 private String lastName;
 private String companyTitle;
 private String emailAddress;
 private String phoneNumber;
 private String companyName;
 private String address1;
 private String address2;
 private String address3;
 private String city;
 private String state;
 private String province;
 private String postalCode;
 private String countryName;
 private List productTypes = null;
 private List productTypeAcronyms = null;
 private List productTypeIds = null;
 private List tradeNameIds = null;
 private List tradeNames = null;
 private TorqueDb torqueDb = null;
 public UserView() { }
 * @return String
 public String getAddress1() {
 return address1;
 * @return String
 public String getAddress2() {
 return address2;
 * @return String
 public String getAddress3() {
 return address3;
 * @return String
 public String getCity() {
 return city;
 * @return String
 public String getCompanyName() {
 return companyName;
 * @return String
 public String getCompanyTitle() {
 return companyTitle;
 * @return String
 public String getCountryName() {
 return countryName;
 * @return String
 public String getEmailAddress() {
 return emailAddress;
 * @return String
 public String getFirstName() {
 return firstName;
 * @return String
 public String getLastName() {
 return lastName;
 * @return int
 public int getMemberId() {
 return memberId;
 * @return String
 public String getPhoneNumber() {
 return phoneNumber;
 * @return String
 public String getPostalCode() {
 return postalCode;
 * @return Set
 public List getProductTypes() {
 return productTypes;
 * @return String
 public String getProvince() {
 return province;
 * @return String
 public String getRole() {
 return role;
 * @return String
 public String getState() {
 return state;
 * @return int
 public int getUserId() {
 return userId;
 * Sets the address1.
 * @param address1 The address1 to set
 public void setAddress1(String address1) {
 this.address1 = trimString(address1);
 * Sets the address2.
 * @param address2 The address2 to set
 public void setAddress2(String address2) {
 this.address2 = trimString(address2);
 * Sets the address3.
 * @param address3 The address3 to set
 public void setAddress3(String address3) {
 this.address3 = trimString(address3);
 * Sets the city.
 * @param city The city to set
 public void setCity(String city) {
 this.city = trimString(city);
 * Sets the companyName.
 * @param companyName The companyName to set
 public void setCompanyName(String companyName) {
 this.companyName = trimString(companyName);
 * Sets the companyTitle.
 * @param companyTitle The companyTitle to set
 public void setCompanyTitle(String companyTitle) {
 this.companyTitle = trimString(companyTitle);
 * Sets the countryName.
 * @param countryName The countryName to set
 public void setCountryName(String countryName) {
 this.countryName = trimString(countryName);
 * Sets the emailAddress.
 * @param emailAddress The emailAddress to set
 public void setEmailAddress(String emailAddress) {
 this.emailAddress = trimString(emailAddress);
 * Sets the firstName.
 * @param firstName The firstName to set
 public void setFirstName(String firstName) {
 this.firstName = trimString(firstName);
 * Sets the lastName.
 * @param lastName The lastName to set
 public void setLastName(String lastName) {
 this.lastName = trimString(lastName);
 * Sets the memberId.
 * @param memberId The memberId to set
 public void setMemberId(int memberId) {
 this.memberId = memberId;
 * Sets the phoneNumber.
 * @param phoneNumber The phoneNumber to set
 public void setPhoneNumber(String phoneNumber) {
 this.phoneNumber = trimString(phoneNumber);
 * Sets the postalCode.
 * @param postalCode The postalCode to set
 public void setPostalCode(String postalCode) {
 this.postalCode = trimString(postalCode);
 * Sets the productTypes.
 * @param productTypes The productTypes to set
 public void setProductTypes(List productTypes) {
 this.productTypes = productTypes;
 * Sets the province.
 * @param province The province to set
 public void setProvince(String province) {
 this.province = trimString(province);
 * Sets the role.
 * @param role The role to set
 public void setRole(String role) {
 this.role = trimString(role);
 * Sets the state.
 * @param state The state to set
 public void setState(String state) {
 this.state = trimString(state);
 * Sets the userId.
 * @param userId The userId to set
 public void setUserId(int userId) {
 this.userId = userId;
 * @return List
 public List getProductTypeAcronyms() {
 return productTypeAcronyms;
 * Sets the productTypeIds.
 * @param productTypeIds The productTypeIds to set
 public void setProductTypeAcronyms(List productTypeAcronyms) {
 this.productTypeAcronyms = productTypeAcronyms;
 public List getProductTypeIds() {
 return productTypeIds;
 public void setProductTypeIds(List productTypeIds) {
 this.productTypeIds = productTypeIds;
 private String trimString(String str) {
 String tmp = null;
 if (str != null)
 tmp = str.trim();
 else
 tmp = str;
 return tmp;
 public List getTradeNameIds() {
 return tradeNameIds;
 public List getTradeNames() {
 return tradeNames;
 public void setTradeNameIds(List list) {
 tradeNameIds = list;
 public void setTradeNames(List list) {
 tradeNames = list;
 public TorqueDb getTorqueDb() {
 return torqueDb;
 public void setTorqueDb(TorqueDb db) {
 torqueDb = db;
 public int getCompanyId() {
 return companyId;
 public void setCompanyId(int i) {
 companyId = i;
Question:
How do I insert the code I assembled:
<logic:present name="UserContainer" property="userView" scope="session">
 User
<bean:write name="UserContainer" property="userView.firstName" scope="session"/>
<bean:write name="UserContainer" property="userView.lastName" scope="session"/>
! 
</logic:present>
<logic:present name="UserContainer" property="userView" scope="session">
Company
 <bean:write name="UserContainer" property="userView.companyName" scope="session"/>
! 
</logic:present>
INTO the function:
function AppSubmit() {
 str1 = "Submitting this form will begin the approval process.";
 str2 = "You will not be able to come back to this form to edit it again.";
 str3 = "Do you want to continue submitting this form?";
 if((confirm(str1 + "\n" + str2 + "\n" + str3))){
 document.forms[0].status.value="Submitted";
 document.forms[0].submit();
So that the popup window will show the [username], [CompanyName], [Date]. I can�t find any doc�s on how to insert logic into a function with str�s.
Any help would be very much appreciated. Thanks in advance.
Applications used by me: Sun solaris 8 server, Tomcat 4.1.24, pulling from postgresql 7.3, and I edit in Eclipse 2.11.

if the user info is in a bean, you can write it out:
function AppSubmit() {
str1 = "welcome, <bean:write name="UserContainer" property="userView.firstName" scope="session"/> ...";
The javascript code will is interpreted only on the browser, it has no idea that it was written with fixed strings or inserted from the bean.
If the user info is in form fields, you can do something like this:
function AppSubmit() {
str1 = "welcome, " + document.forms['myform'].username.value + " ...";
...

2nd password on digital signature file

I am deploying Acrobat Standard 9 in a regulated environment (21 CFR Part 11) and need to have the digital signature file require a second password. While I know this is possible it does not seem to be a feature activated upon a default install. How do I turn on this feature?

Hi Madam Curie,
Part of the problem is the phraseology is incorrect so I'll start with some basic so we are all speaking the same language.
One thing to realize is you can digitally sign any piece of electronic data just like you can use you pen to sign any physical object such as a piece of paper, some one's cast, a wall, or you photo for your fans. In the electronic world you can sign your e-mail, your Word document, or as far as I'm concerned (realizing that I'm biased ) the most important thin, a PDF file.
A digital ID in the electronic world is analogous to a pen in the physical world. It is what you use to create a digital signature. A digital ID is comprised of three pieces; a public key, a corresponding private key, and a block of text with some identifying information. When the digital IS is initially created the public-key is signed with a private key. If the public key is signed with it's corresponding private key the digital ID is know as a "self-signed" digital ID. If it is signed by a different private key, the owner of that key becomes the issuer of the digital ID that it signs.
A digital signature in the electronic world is analogous to a wet ink signature. You use a digital ID to create a digital signature.
The next thing to realize is a digital signature is cryptographic blob of data and is not something one would normally see. If you are geeky enough you can decode one and view it in a special purpose viewer, but for the most part nobody ever sees the signature contents.
When you do sign a PDF file you can either create a visible signature or an invisible signature. In the case of the later, all you do is write the digitally signed blob of data into the PDF file and don't bother creating any visual representation. It's the visual signature that throws most people for a loop, but the key thing to understand is the visual appearance you see in the signature field (which is nothing more than a special purpose text field) is NOT the signature, it is just a representation of the actual signature which you never see.
The visual appearance is comprised of three things, a background (which by default is the PDF trefoil logo) and a foreground that is divided into two halves, text and a graphic.
Acrobat (and when I say Acrobat I really mean both Acrobat and Reader) will let you create a digital signature with any digital ID that you have that is within it validity period, and includes digital signature as a key usage. The digital ID can be saved in several locations that Acrobat has access to. One is file on disk. The file would have the .p12 or .pfx file extension and you would have to add the file to Acrobat using the Security Setting dialog. Another place the digital ID can reside is the Windows Certificate Store of the Mac Keychain. If you've installed the digital ID into one of the OS based storage locations Acrobat will find it without you having to do anything else. Digital IDs can also reside on hardware devices such as a token (they look like a flash drive) or a smart card (they look like a credit card with a gold chip).
So, if you have a digital ID, but Acrobat doesn't know about it need to search you computer for a *.p12 or *.pfx, find out where the file is, than use the Add ID function in the Security Settings dialog to attache the file.
Finally, after you find and attache the file you can modify the Password Timeout to require that a password is always required. Or, if you want to import the file into the Windows Certificate Store you can use the High Assurance option to require a password otherwise Windows will just assume that if you can log in to your desktop then that's good enough.
Steve

21 CFR Part 11

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