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

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.

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/

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

Issue regarding implementing the PM Spare Parts Scanning process

Dear friends,
I have the following issue. It seams that the client, who want to implement the scanning procedure for the PM Spare Parts, can not do this with wireless scanners if the maintenance of the spare parts is done with Inventory Management means and has requested to implement Warehouse Management integration. The fact is that I know that IM can be use. And I know, also, that the basic needs for IM use is that the materials have activated the Batch Management and, the scanning is based on batch bar code/material bar code, together with - for GR - PO bar code and, for GI - the WO bar code. But the issue regarding the wireless baffles me. Please, can you tell me what is the way for setting the wireless connection for the scanners in IM? Thank you very much for your kindness.
Sorin

hi,
It basically depends how your business process is designed for producing Spare Parts before they are reworked.
rework order can be cerated without material with reference to original production order whcih is responsible for proeducing that SFG.
consider below lonks:
http://help.sap.com/bp_bl603/BBLibrary/HTML/151_EN_US.htm

Implementing interfaces and packages part deux

Ok, I've been reading some more posts, and it seems like a lot of people have the same issues as I have right now.
One suggestion that i read was to go into the directory that is the package name.
That is if everything is in package Grid, then go into ./src/Grid directory and then do a javac *.java
when I do that, all my code, even the one that implements an interface will compile. But when I don't do *.java within the /Grid directory, and lets say I am in the ./src directy and I do a javac Grid.Cell (where Cell is the class name), the program will not compile. Why is that...I haven't found a good answer as to why this isn't working yet. Please please help.

I wont get into your directory structure bcz its makin me dizzy..
hopefully it is ok.
can you see a difference between these 2 lines that you say you have tried:
javac *.java <<<< u said compiles
javac Grid.Cell <<<< u said doesnt compile
Two things come to mind:
1.javac needs the .java extension to compile
2.you need to be IN the directory where the source is to compile
k?
try it...

What is the best way to implement Carousel i.e. web part in a site page on office 365 site?

We can implement the Carousel web part in many ways like content By Query Web Part , jquery (nivo) plugin or content search web part etc. But among these which one is the best way to implement to get best performance of the page?
Thanks

content search web part always provides best performance because it uses the search. only consideration you need to take is, it does not display the changes immediately and you need to wait for the incremental crawl to happen.
My Blog- http://www.sharepoint-journey.com|
If a post answers your question, please click Mark As Answer on that post and Vote as Helpful

SRM 7.0 for Pharma industry

Hi,
We plan to implement SRM 7.0 for a pharma industry. Will all the FDA compliances be met in the SRM system or do we need to handle it by some customisation?
Regards

Hi,
As SRM 7.0 is part of the Business Suite the FDA compliance assessments are detailed here:
U.S. Food and Drug Administration (FDA) Title 21 Code of Federal Regulations (CFR) Part 11 [original link is broken]
Hope this helps.
Regards,
Jason

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

Implementing QM

I am implementing QM for purchased parts.
I wanted to know that what are the master data I need to maintan,what configuration I have to do ,what transaction codes I have to use and what is the QM cycle.
ravi

Hi,
QM Cycle --When you will do GRN of materail against purchase order inspection lot will get generated & stock wil get moved to quality then QC person will take result record ,QA person will give Uasge decision ,stock posting.
When you do GRN 101 movement will take place & after usage decision .stock posting 321 movement will take place.
Master data.
In Materai l master Quality MANGEMENT VIEW ACTIVATE INSPECTION TYPE 01
You need to create inspection plan for same material with usage 5 ,then in inspection plan you need to put MIC ( Master inspection charecteristic )
So that based on that result record & usage decision can be possible.
Still any information if you want please revert me back.
Regards
SANIL

Creating an application server stub until the JCA is fully implemented

Greetings,
          We have pretty much decided that the Java Connector Architecture is the
          way to go, when it comes down to integrating with EIS systems.
          However, the problem still remains that the JCA spec is not fully
          supported in the current beta release of the Connector implementation
          within WLS 6.0. In particular,
          I see that only non-transaction Resource Adapters can be deployed in
          this release (local transaction and XA transaction ones will have to
          wait until the full release in the summer).
          However, what our group wants to do is write XA-compliant Resource
          Adapters, even ahead of the actual support for them in the product. The
          issue for us is how to structyure our implementation so that we end up
          with a minimal re-write when the full implementation of the spec
          arrives.
          It seems to me that if I wanted to have support for XA-compliant
          Resource Adapters NOW, I would have to actually write some of the code,
          that would otherwise be part of the application server/container,
          myself. In particular, it is the code that "enlists" the XAResource
          object, which is associated with the ManagedConnection that an
          application bean asks for, with the Transaction Manager that is later
          going to coordinate things in the global XA transaction.
          Let me describe how I see things:
          when the application component calls into the Resource Adapter for a
          connection handle, the ConnectionFactory class according to the spec)
          delegates the call to the application server ConnectionManager (that it
          has been initialised with, typically at creation time), which in turn
          calls the createManagedConnection method of the ManagedConnectionFactory
          class inside the Resource Adapter.
          Now, I want to emulate the application server so that the
          ConnectionManager class is in fact implemented in my Resource Adapter.
          That I guess will not be a problem. However, the next thing IS (in the
          current BETA release): the application server code would normally
          retrieve the XAResource instance that is "hanging" off the
          ManagedConnection that has just been created and would "enlist" this
          with the Transaction Manager. Thereafter, everything would follow the
          normal XA transaction route, as the Transaction Manager would start
          calling back into the XAResource, notifying it on the status of the
          global XA transaction (start, end, prepare, commit, abort).
          Looking at the JTA specification, an in particular at what the
          application server code has to do, I see the following set of
          interactions:
          TransactionalResource res = ResourceFactory.getTransactionalResource();
          XAResource xaRes = res.getXAResource();
          (TransactionManager.getTransaction()).enlistResource(xaRes);
          <<<<<<<<<------------ how do/can I, in
          application code, within the Resource Adapter in fact, get hold of the
          TransactionManager instance? This is trivial when it is implemented
          within the app server code, but could I also do this?
          This will obviously be an interim solution for us: we will implement a
          very small part of the appliction server logic (you could call it a
          stub) around the registration of the XA resource with the global
          transaction manager. The aim is really to write something that will
          appear to our application beans as well as to the rest of the Resource
          Adapter as something that is behaving in the same way as the application
          server would (in the full implementation of the JCA spec), and would
          also ensure that neither our application component code nor our Adapter
          code would not have to be dramatically changed when that app server
          piece of the JCA-specified system contract implementation is in place.
          I realise that the APIs to the Transaction Manager implementation within
          WLS are "private" and that people may not want us to be using them. But
          it is the only way that I see for us to create something (Resource
          Adapters) which are a)XA compliant and b) will only have to change
          minimally, if at all, when the actual implementation is in place.
          I would appreciate any thoughts from BEA folks out there. Also, if you
          see another way of solving my problem (support global XA transaction
          within my Resource Adapters, AND minimal re-write) that I may be
          missing, I would appreciate your feeback around that.
          Many thanks in advance
          Kostas
          Kostas Karagianidis
          Technical Consultant
          PricewaterhouseCoopers
          Delta 602, Delta Business Park
          Swindon SN5 7XJ, Wiltshire
          United Kingdom
          Tel: +44 1793 536291
          Fax: +44 1793 529641
          Mobile: +44 7768 083452
          e-mail: [email protected]
          The information transmitted is intended only for the person or
          entity to which it is addressed and may contain confidential and/or
          privileged material. Any review, retransmission, dissemination or other
          use of, or taking of any action in reliance upon, this information by
          persons or entities other than the intended recipient is prohibited.
          If you received this in error, please contact the sender and delete the
          material from any computer.


Did you sign your jar file for JWS? I don't think the security manager will allow a filebrowser if the jar is not signed.
Edited by: Plee on Dec 29, 2008 6:54 AM

How to implement SCD and outer join in OBIEE

Hi Experts,
1.How we can implement SCD1 and SCD2 in OBIEE.
2. How to implement outer join..? Can we implement outer join in physical layer.?
Regards
Frnds

1. Better to implement this as a part of data warehouse/ETL. If you insist there is explanation on how to work with SCD's in Administrator in some Oracle University Student Book, I think it's for Siebel Analytics version.
2. Implement outer joins using complex joins in BMM (type option). It's possible to implement in physical layer only in obiee views (new physical table/table type - select), otherwise not, you cannot specify outer join in the physical layer using complex joins.
Regards
Goran
http://108obiee.blogspot.com

Issue in performing search using advanced search web part with any of these keywords.

Hi,
I am implementing advanced search web part, and i have added few columns [ these columns are doc lib columns and NOT site columns ],property restrictions dropdown.
and when i try to search for the documents, contents from the subsites with the applied item from the property restrictions dropdown and with "contains" keyword , and filled-in the "any of these keywords"
textbox,
the search results are not displayed , though there are multiple documents which has the keywords.
am i missing any steps here.? i have ensured that managed properties were created and added in the properties.xml file in the adv.search web part's properties.

hi Steve,
thnx for the reply.
here is my xml file details:
<PropertyDef Name="DocComments" DataType="text" DisplayName="Comments"/>
    <PropertyDef Name="CreatedBy" DataType="text" DisplayName="Created By"/>
    <PropertyDef Name="ModifiedBy" DataType="text" DisplayName="Last Modified By"/>
    <PropertyDef Name="WellOWSTEXT" DataType="text" DisplayName="Well Name"/>
    <PropertyDef Name="BlockOWSTEXT" DataType="text" DisplayName="Block Name"/>
    <PropertyDef Name="ProjectOWSTEXT" DataType="text" DisplayName="Project Name"/>
    <PropertyDef Name="LocationOWSTEXT" DataType="text" DisplayName="Location"/>
    <PropertyDef Name="DisciplineOWSTEXT" DataType="text" DisplayName="Discipline"/>
</PropertyDefs>
<ResultTypes>
    <ResultType DisplayName="All Results" Name="default">
      <KeywordQuery/>
      <PropertyRef Name="Author" />
      <PropertyRef Name="Description" />
      <PropertyRef Name="FileName" />
      <PropertyRef Name="Size" />
      <PropertyRef Name="Path" />
      <PropertyRef Name="Write" />
      <PropertyRef Name="CreatedBy" />
      <PropertyRef Name="ModifiedBy" />
      <PropertyRef Name="WellOWSTEXT" />
      <PropertyRef Name="BlockOWSTEXT" />
      <PropertyRef Name="ProjectOWSTEXT" />
      <PropertyRef Name="LocationOWSTEXT" />
      <PropertyRef Name="DisciplineOWSTEXT" />
    </ResultType>
</ResultTypes>
</root>
am using the managedproperties without spaces. the problem is that, when i give the word/words
in the "any of these words" textbox and if i give a value with the "contains" dropdown
its not allwoing me give proper results.
After adding these property restrictions i have done the full crawl again.
@Steven Adnrews: i have done the full crawl, multiple times. Though these columns are NOT created as site columns, it came as managed properties in my Srch Serv.Appln, search schema page.
@Fabian: i am not getting your point.Can you pls tell,where will I see the xsl. i think, the xsl editor and xsl configuration has been replaced by html display templates in SP 2013 Search.

Pharma implementation USFDA ---21 CFR Part 11

Similar Messages

Maybe you are looking for