Article of the month Jan 08

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
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Software Master validation Plan -Top Tips

The validation plan is a strategic document that should state what is to be done, the scope of the approach, the schedule of validation activities and tasks to be performed. The plan should also state who is responsible for performing every validation activity. Once reviewed the validation plan should then be signed off by the associated project team members.The validation plan is a strategic document that should state what is to be done, the scope of the approach, the schedule of validation activities and tasks to be performed. The plan should also state who is responsible for performing every validation activity. Once reviewed the validation plan should then be signed off by the associated project team members.

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Nice article, I am actually developing a MVP for a web-based pharma system and this will help me greatly.

Thank you

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Excellent article

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Very nice anf informative article

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good article this month

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This shall be of great help for my establishing MVP and PV guideline of process chromatography. When i finish the work as a draft one, I will be again here.
Thanks again and best regards;)

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The summary information I have seen for the changes from GAMP 4 to GAMP 5 appear to scale back the validation documentation process somewhat. I work for a small nonprofit, so buying the full GAMP 5 package from ISPE would be a budget-breaker right now. Has anyone in here created validation procedures against GAMP 5, or modified validation processes in accordance with the changes that were implemented with GAMP 5, and if so, did you modify or exclude any elements of the software validation plan described in this article?

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Hello,

Its a nicely structured article.

I would like to add here that nowdays we are also adding following two sections in VMP.

  1. Revalidation or requalification - Considering lifecycle approach, VMP should also address criterias for revalidation or requalification as the case maybe. This also includes changes and risk assessment of same before deciding for revalidation.

  2. Ongoing Operations and Control - VMP also briefly talks about maintaining the system in validation stage, which includes various SOPs, change management, performance management, periodic review etc.

Trust above is useful.

Regards

Jaydeep D. Chhatrapati
Epitome Technologies.

Hope above are