Computer System Validation using a risk based approach

Looking for simple, compliant Computer System Validation solutions?

PharmOut are specialists in Computer System Validation and can assess your computer systems, or proposed computer system, against GAMP software life cycle development model (V model) and part 11 / annex 11. We will then recommend any remediation required to comply with "GAMP 5" and the 21 CFR Part 11 or Annex 11 requirements.

When seeking to comply with Part 11 a common mistake is to ignore the predicate rules and incur unnecessary expense in areas where it is simply not needed.

The FDA, after consultation with industry and the ISPE, released an updated risk-based guidance document. The guidance document was released four years ago, yet it is still common practice to over-elaborate this requirement

Criticality/risk assessment

PharmOut's validation professionals can lead the Risk/Criticality Analysis and assist with determining the impact level of computer systems. This assessment is guided by a Risk Analysis, assessing the likelihood of detection and impact of failure and documented in a matrix which indicates the level of qualification or validation recommended.

When performing computer system validation, GAMP 5 categories are a useful, well recognised tool to help validate computer systems.

Design

PharmOut consultants can assist you in developing the User Requirements Specification (URS), the basis for computer system design. From the URS the design process begins. By using Quality-by-design principles, we then perform design reviews to determine the optimal design, ensuring that profitability and quality targets are met.

Protocols for Qualification/Testing

The boring bit that every Life Science professional dreads regardless if you work in pharmaceuticals or medical devices....

So, outsource it to PharmOut! We can either provide templates and do the testing on a fixed price basis. Or we can provide the resources to perform the testing & documentation, under your supervision.

Also IQ, OQ and PQ are no longer used, this has been replaced with "verification", the emphasis is now on the activity, verification, not on the piece of paper that "qualification" implies, i.e. IQ, OQ and PQ.