Computer systems validation has evolved over the last two decades. In the light of FDA’s new “GMPs for the 21st Century Initiative” there are plentiful opportunities to redefine, streamline and make computer validation a true value added exercise. The focus of our practice is to ensure that the computer systems in the GxP world are reliable and robust through validation. We apply the knowledge base that our practice has created, to design validation programs, which not only exceed FDA expectations, but align with our client’s business needs.

Our Computer Systems Validation (CSV) methodology strives to achieve the 4 Rs (Reliability, Robustness, Repeatability and Risk Based) in any application we validate. Our System Development Life Cycle Methodology (SDLM) is consistent with GAMP, ISO and other industry standards. We call our methodology “Good Pragmatic Engineering Practices (GPEP)". We leverage Risk Management Techniques in all our engagements.

Some of our specific offerings are

Develop Validation Plans and Project Plans

Evaluate Technology and Vendors

Perform Vendor Audits

Develop Software Quality Assurance Plans

Develop User Requirements, Functional Requirements, System Specifications

Perform Design and Code Reviews

Perform Risk Analysis

Support Development, Installation and Commissioning

Implement Unit and Integrated System Testing

Implement Factory / Site Acceptance Testing (FAT / SAT)

Develop and Implement IQ, OQ and PQ Protocols

Develop Traceability Matrices

Develop Policies and Procedures (SOPs)

Perform Systems Optimization