UD authorisation

[Former Member]

HI Guru's

In Pharma companies, what is the practice for RR and UD authorisation

means we need to create different groups for recording the result, valuate the result by another gr and UD by 3rd group (pur/prod)

My question is Lab people authorise to do UD stock posting ???

Follow up action for automatic stock posting can be assigned for UD codes ....

what is normal practice........

Please throw some light

Thanks

[Former Member]

Hi Sami,

- All of first let me know you, that RR is done through a different trx code.

- The RR Valuation is can be controlled with the other object in RR.

- And UD can is done through QA11.

- You can define the Back ground stock posting in UD Code it self (trx QA51)

- So you can restrict these all different activites at trx level &/or object level.

Regards,

Shyamal

[Former Member]

Hi shyamal

Thank you for your quick response, Can you please explain in detail(i know how to do follow up action in QS51) I want to know what is the best / business process in Pharma industry....

Can you please give some details about validation process (SAP QM perspective) in life science /Pharama industry. Plz explain in detail

Thanks again

Sami

[Former Member]

Hi Sami,

I think you should Go like this,

All of first I would advice you to create three roles. Give some logical names to it...For example.

1] Data Recorder. (For that group which is supposed to do RR)

2] Data Verifier.(For that group which is supposed to do RR Valuation)

3] Data App rover (For that group which is supposed to do UD)

There are two separate and different objects are available for RR and RR Valuation. So your first question of RR to be done by a group and RR Valuation to be done bu another group will be solved by assigning these two different "Roles"

Now there is another functionality called "Mat. Auth. Group, Insp. Lot Approval, Digital Signature" at QM view of MM is available. So create an authorization object at following path.

SPRO>>>Quality Management>>>Environment>>>Central Functions>>>Authorization Management>>>Define Authorization Groups and Digital Signature.

And assign this Authorization group to the Third role only. So system will not allow any other users to perform UD.

Now let me make it clear that there is no need of follow-up action at QS51 to make the Stock posting in Back ground.

There is a check box in QS51 screen named as "Stock screen backgr."

Just activate this check box for the UD Code, And system will perform the Stock posting according to the ""Posting Proposal to UD" Only.

And normally in Pharmaceutical industry Stock is released / rejected from QI Stock. by QC only (QM Guy) not by the store.

More over then this I would like to share some document related to UD in Pharmaceutic

Using Digital Signatures in SAP® QM to Meet Regulatory Requirements

Assigning Authorizations

Pls revert for further inputs.

Regards,

Shyamal

[Former Member]

Hi Shyamal

Thanks for detailed info.(points awarded)

Can you please give some details about "validation process" in life science /Pharama industry.

What is SAP QM consultant role..

Plz throw some lights...

Thanks again

Sami

[Former Member]

Dear Sami,

(points awarded)

doesn't matter, as specially when they are awarded not according to the contents.

Anyways,

SAP validation is totally different subject then this thread but, you have asked for it and luckily I am also searching for some Validation work around for SAP these days so I think what ever the information I have gathered so far will defiantly help you and would like to share with you.

SAP Validation is a very big subject But at a broader level, SAP validates data on 3 levels 1. Configuration data/ Master data 2. Transaction data 3. Business user 1.A. Configuration data level validation When we do the configuration, there are certain steps and procedures should be followed. Certain configuration steps are always to be copied using the Standard provided by SAP. Because there are various tables and fields gets update when we do so. If we create on our own, the related tables fails to get update and there will be an inconsistency in the system. This leads to a major system failure. For example: Setting up the Plant. 1.B. Master data level validation: When ever we create a master data, there are certain data needs to be maintained like Company code, Plant, Purchasing organization, Purchasing group etc.. Based on the nature of master data we create, the information may vary. But it is necessary to maintain those values to ensure that the data is consistent wide the Organization. It is also validated that, the data is in sink with what's defined in the configuration 2. Transaction data level validation When ever we perform any transaction, based on the transaction the users may use some master data as reference data to create the data. There could be some business requirement that some of the information's are mandatory. There could be some business requirement like the transaction should be allowed only for a specific plant or only when the desired condition met. Each of these conditions are validated before the system saves the data. 3. Business user As per the business, there are various user roles are defined in SAP with various levels of authorization. The authorization specifies who is allowed to perform what? when ever the user try to perform any transaction, system validates the authenticity whether he/ she is authorized to perform the transaction or not. So this way there are lot of validations in SAP in each and every step. The validation ensures that the system works consistently, error free, authenticated for optimum system efficiency

Apart from these I would suggest you to refer these links

[Approval Using Digital Signatures|http://help.sap.com/saphelp_46c/helpdata/en/83/acd928db1c11d397d3080009c17b92/frameset.htm]

[Pharmaceuticals Compliance Tools and Validation Services|http://www50.sap.com/businessmaps/55BAC75187CC4DE4AED24F9CCDC69DE6.htm]

Note: If you wish to right (Points Awarded) then pls award according to the content of the reply, other wise pls don't mentioned "POINTS AWARDED"

Regards,

Shyamal

[Former Member]

HI Shyamal

Thanks for detailed info

sorry for that word

It is very useful info to me

I want to know the role of SAP consultant - for validation purpose

As a consultant what is the extra responsiblity in Pharma industry - implementaton..

Thanks again

Sami