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

Similar Messages

PI sheet for pharma industry - step by step customization required very urg

Hi,
We are implementing sap PP-PI for pharma industry.Can some one please send some good document explaining the customization for PI sheet , custom pi sheet .
any help is gretaly appreciated.
sonia

Hi,
Please check with following Baseline Buliding Block link provided by SAP. Here u can select industry type and contry type.
<b>http://help.sap.com/bp_blv1470/BL_UK/index.htm</b>
i hope this will help.
regards
pardeep

Business Process For pharma industry

hi,
can u pls tell me about business process for pharma industry.
regards
Guru

Hi,
the best place to get an intial overview of the pharma business processes is to look at the solution map. This can be found here: http://www.sap.com/industries/lifesciences/index.epx . On the right there is an area called "SAP Business Maps for Life Sciences".
I hope this helps.
Oliver

"Cleaning Validation Process Scenario" in SAP QM/PM for Pharma Industry

Dear Gurus,
I have a client requirement in the Pharma Industry. The scenario needs to be mapped in SAP for which I need your help.
The scenario is that the company is making medicines (tablets/capsules). Whenever, there is a changeover of the product, there are certain regulatory requirements which the client needs to adhere to.
For example, a shutdown of machinery for 10-12 days may be planned during which the machines are cleaned with soap/cleaning agents. Now, during this cleaning process, the QA department would take samples of the soap water recovered after cleaning process. These samples would be inspected for residues of the previous product that was being run on the line.
If everything is ok, then the approval is given by QA to start the next product.
This process has to be mapped in SAP, maybe in QM or PM.
I thought over the following process. Please let me know your inputs to fine tune the below process -
1. As the shutdown for changeover will be a planned one, we can create a Maintenance Plan in IP42.
2. Schedule the Mantenance Plan by IP10.
3. Release the maintenance plan in IP10.
4. Preventive Maintenance order will be created. (Also assign an Inspection Type in config to this maintenance order so that inspection lot also is triggered. The doubt here is that the inspection lot would be triggered for all preventive maintenance orders which may not be required. How to control this?)
5. Carry out Result Recording in QA32.
6. Confirm Preventive Maintenance order in IW41.
7. Carry out Usage Decision in QA32. The status of order will now become TECO.
8. Order Settlement in KO88.
9. Business Completion of Order in IW32
Thanks for you time!
Regards,
Nitin

Your ASIS Process
1. Cleaning is done by maintenance before change over
2. Inspection is done to ensure that cleaning is acceptable
3. Records of inspection are to be maintained
4. Information is to be sent to concern regarding quality testing and its status
5. Change over performed
You can MAP this by Notifications also. Follow the steps
1. Create a new notification type ( config)
2. Ensure you have following mapped in the action box (config)
    a. Send a mail
    b. Create a inspection lot
    c. Create a QM order
    d. Close Notification
The process will be as follows
1. Create a dummy material and activate insp type 08 in the QM set up.
2. PM creates the notification (t-code QM01) (New notification & triggers a mail (Action box) which is delivered to QC as information regarding the start of process .
3. QC on looking at the information creates the inspection lot through the notification (action box) the QTY specified in the notification is moved from unrestricted to Quality .
3. Perform RR & UD and post stock to unrestricted
4. Close the notification giving your remarks or set the notification for further processing if required .
Note :
1. The material is a dummy material
2. The intial stock can be one qty which is posted to quality -
from unrestricted and then again to unrestricted.
Deepak

"Cleaning Validation Process Scenario" in SAP PM/QM for Pharma Industry

Dear Gurus,
I have a client requirement in the Pharma Industry. The scenario needs to be mapped in SAP for which I need your help.
The scenario is that the company is making medicines (tablets/capsules). Whenever, there is a changeover of the product, there are certain regulatory requirements which the client needs to adhere to.
For example, a shutdown of machinery for 10-12 days may be planned during which the machines are cleaned with soap/cleaning agents. Now, during this cleaning process, the QA department would take samples of the soap water recovered after cleaning process. These samples would be inspected for residues of the previous product that was being run on the line.
If everything is ok, then the approval is given by QA to start the next product.
This process has to be mapped in SAP, maybe in PM or QM.
I thought over the following process. Please let me know your inputs to fine tune the below process -
1. As the shutdown for changeover will be a planned one, we can create a Maintenance Plan in IP42.
2. Schedule the Mantenance Plan by IP10.
3. Release the maintenance plan in IP10.
4. Preventive Maintenance order will be created. (Also assign an Inspection Type in config to this maintenance order so that inspection lot also is triggered. The doubt here is that the inspection lot would be triggered for all preventive maintenance orders which may not be required. How to control this?)
5. Carry out Result Recording in QA32.
6. Confirm Preventive Maintenance order in IW41.
7. Carry out Usage Decision in QA32. The status of order will now become TECO.
8. Order Settlement in KO88.
9. Business Completion of Order in IW32
Thanks for you time!
Regards,
Nitin

Hi,
For multiple samples we can use no of sample(SAmpling Procedure) to record more than one results and system will calculate the arithmetic mean of all results of all sample
For this we have to maintain control indicator of MIC . Single result radio button will enable us to record results based on the number of sample defined in sampling procedure
And if you have requirement like different target values at different level,
Then you can configure inpection point -
SPRO > Quality Management > Quality Planning > Inspection Planning > General > Define Identifier for Inspection Points
in this Field act - 2 and give description
Regards,
SandeepV

Batch Managemnt for Pharma Industry

Dear All Hi,
I have the following scenario for material level batch management & all external numbering system & repeation of B/No., should not happen.
1.All RM's will have a batch number assigned with manufacturing & expiry date, i.e. when GR is done then system should ask for B/No., manufacturing & expiry date & this data entry has to be mandatory
2.For FG the B/No., is assigned at the time of process order creation/release & without this the process order should not allow to save order & .
Also the requirment For manufacturing & expiry date for FG is MM/YYYY & by default system should diplay the manufacturing & expiry date while making GR by considering the confirmation date of process order as manufacturing & number days defined in material master as expiry date in non editable fields
Please do tell me what settings in masters & SPRO that i should maintain to have this functionality working

Hi
answers for your issues :
1.your Q:all external numbering system & repeation of B/No., should not happen.
Ans: you can use user exit available in SPRO under the step
Batch number assignment - Coordinate with your technical team.
2.next Q:All RM's will have a batch number assigned with manufacturing & expiry date, i.e. when GR is done then system should ask for B/No., manufacturing & expiry date & this data entry has to be mandatory
Ans: Batch number will be assigned wih the prior answer.
Mfg & expiry date will be done by config setting:
OMCV: for movement type 102 select option"2"
3.Next Q For FG the B/No., is assigned at the time of process order creation/release & without this the process order should not allow to save order & .
Ans In Material master MRP2 for filed Batch entry select either option"1" or "3" . this will give batch while releasing the order.
4.QAlso the requirment For manufacturing & expiry date for FG is MM/YYYY & by default system should diplay the manufacturing & expiry date while making GR by considering the confirmation date of process order as manufacturing & number days defined in material master as expiry date in non editable fields
AnsBy ans for q2 above the first part you will getmfg date expiry date .
The fileds in the material master "number days defined in material master as expiry date in non editable fields"
you can make in Tcode OMS9.
Hope it will solve your requirement.
Regards
YMREDDY

Sales deals in pharma industry

can somebody tell me what a Sales Deal is?
all i know is that there a corresponding Contract for every Sales deal that we have.
sk

Hi Ravi,
Please go through the information provided by SAP Best Practices for Pharma Industry,if this suits your business process suits you may go ahead with this.
[SAP Solution Map for Pharmaceuticals|http://help.sap.com/bp_pharmav1600/Pharma_US/HTML/solution_map_EN_US.htm]
[Preconfigured Scenarios|http://help.sap.com/bp_pharmav1600/Pharma_US/HTML/preconfigured_scenarios_pharma_EN_US.htm]
Please do let me know if you have any questions.
Thanks and Regards,
Naveen Dasari.

BW Pharma Industry

Hi All,
Have u any one worked under pharma industry...what type of reports client except from BW (pharmaceuticals) and what would there requirements. consider this an very urgent.
Thanks in Advance,
Anil.

Hello,
Please see below link for standard business content customized for IS-Pharma...
http://help.sap.com/saphelp_nw04/helpdata/en/cb/e11540bf1af72ee10000000a1550b0/frameset.htm
hope it helps..
cheers,
Vishvesh

CTM or optimizer in Pharma Industry

Dear Gurus,
Is CTM or Optimizer usually used in Pharma industry? I understand the reasons behind the selection of SNP solution that if you just need a simple supply planning with capacity levelling, you go for Heuristics, if you need rule based go for CTM and if you need cost optimization, you go for Optimizer.
In your experience, does Pharma industries go for CTM or optimizer? While I understand it's specific to the business model , does the Pharma industry process support the CTM or Optimizer?
Thanks.

Visu,
I shall put forth a different argument based on my experience with one of the pharma company mentioned by Ken and another that is not listed in the discussion so far.
According to my experience Pharma industry is more of Supply-driven rather than Demand-driven.
As a result PPDS pretty much is the most important planning engine where long-term sequence of orders are carried out. Campaign-based planing is pretty much a mandatory requirement in case of API / Active Ingredient manufacturing. To start with SNP is not capable of doing Campaign-based planning. So it does not matter if its CTM or Optimiser. Frankly speaking I find Heuristic much easier to understand and handle.
One Golbal Pharma major uses SNP for long-term planning (that too heuristic) basically to pass the demand from the markets all the way to the API manufacturing plants. Then PPDS is run for a shorter horizon depending on the product level. For APIs the PPDS plan is almost 1 year out - because when you are doing campaign planning each campaign (for a particular API) typically lasts 2-3 months. That means if on a manufacturing line (a complex series of pressure vessels and piping) you need to manufacturing 4 different APIs you will make the same API after 1 year (3 months per campaig x 4 APIs). For Semi-finished products (like forming the tablets) the production process is faster and hence PPDS planning is not done for 1 year out but maybe upto 6 months. As for the final finish and packing lines each Production Run lasts for few days and hence te PPDS plan is say upto 3 months only. Now given these different production levels you need to maintain master data parameters suitably to match PPDS and SNP planning runs.
This client did not use SNP Optimiser or CTM engine in their planning when I was working. Even now I they are not using these engines.
On the other hand another Indian Pharma major started off APO implementation using SNP especially CTM engine and over a period of time as they rolled out more and more of Production Planning at the plants they realised CTM is not serving the purpose. As far as I know they were in process of switching over to PPDS for the production planning and keep CTM only close to the demand side i.e. the Distribution Centers.
Hope this helps.
Somnath

Business process of Automobile & Chemical & pharma industry

Hi Experts,
If anyone worked in Automobile , Chemical & pharma industry Please provide me various business process that
take place with examples.
Such as Manufacturing , production & sales process etc
Points will be rewarded.
Thanks
Shabnum

Dear Shabnum
Do you think your question is easy to answer.
If you are working in any of these industries, let us know where exactly your problem is, so that somebody would try to answer.
If we take an example for automobile process, client to client the process will vary and it cannot be listed out here.
Thanks
G. Lakshmipathi

OPM implementation in Pharma Industry

Hello All
I am looking for information (case studies/white papers/others) on OPM Implementation in Pharma industry primarily to learn :
- How active drug mfg & formulations mfg was mapped to OPM
- Business requirements that could be fulfilled by standard package
- Business requirements not fulfilled by std package and the workarounds for the same.
Any info this regards would be great to have.
Thank you !

We have implemented OPM in a pharma company. I will try to give you some of the inputs.
- How active drug mfg & formulations mfg was mapped to OPM
These were mapped as items and we used recipe versions extensively. For Samples we used the same itemcode prefixed with S.
- Business requirements that could be fulfilled by standard package
OPM was able to fulfill almost all the requirements of the pharma business.
- Business requirements not fulfilled by std package and the workarounds for the same.
We had problem in costing. The cost is maintained at item level in OPM. However the company wanted the cost at a lot level. For example, the same item could be manufactured inhouse or purchased outside. They wanted to track costs separately. This was not possible in OPM. Hence we mapped the company on Standard cost for accounting purposes. This was more of a compromise.
I have recently implemented lot costing which specifically addresses the above problem.
I feel that Oracle OPM with lot costing will address most of the manufacturing / costing requirements of a pharma industry.
If you want more info. kindly update these columns or you can contact me at [email protected]
Regards
Ram

Which availability check procedure will be approprite for Pharma industries

Hello All,
I am working with a Pharma client.
Please suggest me which availability check procedure will be approprite for Pharma industries.
Depending ATP or On Product Allocation.
Thanking you in anticipation.
Regards
Venkat

Hi,
ATP is a basic availability check which have limited functionality. GATP is a more dynamic checking which is suitable for real-time availability check, which is more appropriate for pharmaceutical industry.
The basic differences between the two checking systems are:
APO GATP:
- Check for several Online Transaction Processing (OLTP)
- Uses Live Cache Technology
- Advanced Basic method
- No restriction for combination of basic methods
- Rules-based substitution
- ATP check in several locations ("global")
- Advanced backorder processing
- Call of production possible
ERP ATP:
- Check possible only in an ERP system
- Uses database tables or shared buffer (ERP server)
- Basic methods
- Restriction for combinations of basic methods
- Standard substitutions
- Check only in one location
- Restricted backorder processing
- No call of production possible
This topic has been discussed before in the forum.
You may find the following thread relevant to you:
GATP
Thanks.

What is the Best practice for ceramic industry?

Dear All;
i would like to ask two questions:
1- which manufacturing category (process or discrete) fit ceramic industry?
2- what is the Best practice for ceramic industry?
please note from the below link
[https://websmp103.sap-ag.de/~form/sapnet?_FRAME=CONTAINER&_OBJECT=011000358700000409682008E ]
i recognized that ceramic industry is under category called building material which in turn under mill product and mining
but there is no best practices for building material or even mill product and only fabricated meta and mining best practices is available.
thanks in advance

Hi,
I understand that you refer to production of ceramic tiles. The solution for PP was process, with these setps: raw materials preparation (glazes and frits), dry pressing (I don't know extrusion process), glazing, firing (single fire), sorting and packing. In Spain, usually are All-in-one solutions (R/3 o ECC solutions). Perhaps the production of decors have fast firing and additional processes.
In my opinion, the curiosity is in batch determination in SD, that you must determine in sales order because builders want that the order will be homogeneus in tone and caliber, and he/she can split the order in diferents deliveries. You must think that batch is tone (diferents colours in firing and so on) and in caliber.
I hope this helps you
Regards,
Eduardo

SRM and MDM for material master in SRM contracts for multiple R/3

Dear all,
my question is:
We are implementing SRM 4.0 in classic scenario with multiple R/3 back-end and we want to set-up Global Outline Agreements in SRM in a multi-backend environment where the Material Master are not harmonized.
We heard that MDM and COntent Integraton can be a solution.
Then detailled question is:
Can we have 2 material numbers (e.g. ABC and XYZ) in 2 different R/3 systems refering the same product.
Have the mapping done in MDM (Content Integrator?) to a third material number:123
Replicating the material master 123 to SRM from MDM(?)
Create global Outline Agreements in SRM for Material Master 123.
Distribute the GOA as Outline Agreement to R/3 system 1 with the translation to ABC and to R/3 system 2 with the translation XYZ, all of that during the distribution step (or another).
Have the call-offs quantities correct on 123 in SRM and BW?
IF yes, how is it working, do you have some documentation discribing the scenario and the config steps to do?
Thanks in avance

Hello RD,
That's a good question.
You are on the right way. MDM is the tool for you.
But..
Content Integrator (CI) was first developped for Shell, to address the need of cross-referencing of material/supplier/category IDs, for:
- reporting purpose (actual Spend Analysis)
- mapping purpose (send of XML PO)
CI was later "fusionned" into the new MDM (1.0) solution.
So now, you can not order CI without MDM (even if some SRM slides still present CI).
But mapping API where developped for all inboud/outbound interfaces in SRM, for materials only (good luck for you).
You will find everywhere this piece of code:
Call ECI
    CALL FUNCTION 'BBP_PRODUCT_MAP'
      TABLES
        it_input          = lt_mapping_in
        et_output         = lt_mapping_out
      EXCEPTIONS
        logsys_not_found = 1
        driver_not_found = 2
        product_not_found = 3
        internal_error    = 4
        OTHERS            = 5.
So it is ok, you have the mapping call, but I don't know if all the rest of the process was really "finalized" (call of API mapping in CI, via XI). I personnaly never used it, but I assume it should work.
I my opinion your process is supported by SAP:
- Extract materials from both R/3 and consolidate them as a single product in MDM.
- Distribute this product into SRM.
- Maintain contracts on those products.
- Distribute them to R/3 (The ECI call is also used during contract distribution).
- Call offs corrects in SRM and BW
For MDM documentation, look at netweaver area of service.sap.com.
For MDM/SRM integration, look at SRM 4.0 spend analysis:
https://websmp206.sap-ag.de/~sapdownload/011000358700004424262004E/GlobalSpendOverview.ppt
For SRM contract distribution, call-offs, BW, look at SRM in details in service.sap.com/srm/SRM4.0:
https://websmp206.sap-ag.de/~sapdownload/011000358700001966382004E/contracten.ppt
For SRM5.0, see online help on help.sap.com.
Rgds
Christophe

Custom screen field in the SRM portal screen for Business Partner Bidder

I need to add a custom screen field in the SRM portal screen for Business Partner. I have added this custom field in the include structure: CI_EEW_BUT000 and activated it.
I was expecting to see the enhanced field available in the SRM portal screen when I create the bidder. But is not available.
The new field are available if I edit an Business partner only.

Hi,
Please look into the following OSS Notes:
Note 675800 - Business partner enhancement SRM on maintenance screen
Note 672960 - User-defined fields 2
Thanks,
Pradeep

SRM 7.0 for Pharma industry

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