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Validation

The document discusses the standard steps for SAP validation projects: 1. SAP analysis to understand system requirements and regulatory expectations. 2. Creation of an action plan to address technical and procedural gaps. 3. A risk assessment of relevant modules to determine validation scope and effort. 4. Validation including a master plan, protocols, and traceability matrix. The most difficult tasks are tracing requirements and identifying key users.

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Dinesh Kumar
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44 views1 page

Validation

The document discusses the standard steps for SAP validation projects: 1. SAP analysis to understand system requirements and regulatory expectations. 2. Creation of an action plan to address technical and procedural gaps. 3. A risk assessment of relevant modules to determine validation scope and effort. 4. Validation including a master plan, protocols, and traceability matrix. The most difficult tasks are tracing requirements and identifying key users.

Uploaded by

Dinesh Kumar
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as ODT, PDF, TXT or read online on Scribd
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SAP Validation

I appreciate your difficulty. SAP Validation is a huge task and it changes from project to project as it depends upon its implementation. We have done number of such projects and no two are similar. et me briefly tell you standard steps devised by us to make the task more organised. !. "ap Analysis # $rying to findout from implemented systems% available documentation% applicable S&Ps present day position of SAP against e'pectations of (egulatory agencies% say )*A. We have devised a checklist and map system against that. +. Action Plan # ,ased on that we create action plan alongwith client% and decide which gaps can be closed technically and which are to be attended procedurely. &f course% cost aspects to be kept in mind. -. (isk Assessment # .e't step is to carryout detailed (isk Assessment of all relevant modules i.e. //0 /aterial1% 2/02uality1 and PP/0Production1. Some scope also falls into *istribution module as well as 3( module depending upon implementation strategy. $his step is very important as it allows you to determine which $#codes or transactions are most important to cover into validatin and which are least. We classify into typical - categories as per "A/P guidelines. )urther validation effort is based on this classification. 4. Validation # $his in a traditional sense starts with creation of Validation /aster plan% Protocols preparation and ends with $raceability /atri'. &ne of the most difficult task in such projects is to trace or identify 5(S and6 or )S. Also most of the time% validation group is assigned task only after system has been implemented and running for more than year7 So finding out what system was supposed to deliver is a major task and this has to involve some senior representative from each user of module. And person has to be one who can define present re8uirements too. So% you have to create a 9ore $eam which includes all above users as well as senior rep. from 2A% 29 % I$ and Validation. At some point of time you may need to involve )inance% if its capital incentive. 3owever they are not actively part of Validation 9ore $eam. $here are of course many things to be considered% however i have tried to summarise above. $rust above is of some help. (gds. :aydeep 9hhatrapati

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