A hybrid system – combining Agile and traditional Waterfall Computer System Validation –  can offer a lean, scalable and risk-based approach when validating GxP systems. It can also accelerate the validation process significantly while enhancing compliance and reducing overall cost, effort, and time.

JDS Approach

Our overall process follows the GAMP 5 validation approach enhanced by some Agile concepts embedded in the validation process.

     We can significantly increase the quality of requirements by conducting workshops with the primary stakeholders to quickly solidify requirements and start the validation process sooner.

     We employ a methodology that reduces non-value-added activities and by using pre-approved templates we can shorten the review and approval cycle.

     And we also conduct all validations using a Risk-based approach which can greatly reduce the testing cycle and help scale down the validation effort while still maintaining compliance. Our approach would be to leverage any testing performed by the Software Manufacturer to save time, resources and dollars.

We can supply a full set of validation Templates that are Industry Best Practice saving design costs and approval cycles time.

User Requirements – Validation Plan – Functional Requirements – Testing Plan/Protocols – Test Scripts – Summary Reports – Validation Summary Report – Release to Production Documents

 As part of the final release to production we also provide a Procedures writing team to help create or modify the required Standard Operating Procedures for the new or upgraded system.

Please call for a Regulatory Assessment so that we can better serve your needs.