BPV offers comprehensive Validation Consulting Services to help life sciences companies navigate the complex process of equipment and system validation. Our team of Subject Matter Experts has extensive knowledge and experience in providing Validation Master Plans (VMPs), computer systems validation, equipment qualifications, process validation, and test method validation services.
At the core of our Validation Consulting services is the development of robust Validation Master Plans (VMPs) and validation protocols. BPV has its own validation protocols and clients can follow our cGMP-compliant documentation or can choose to use their own. Our consultants work closely with clients to understand their specific requirements and develop tailored VMPs that outline the planned validation activities, essential documents, staff responsibilities, and a documented approach for conducting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in compliance with cGMP requirements.
The VMPs created by our validation consultants employ risk analysis to establish the scope and extent of qualification protocols, applicable test methods, critical control points requiring evaluation, sampling locations, frequency, and size, as well as schedules for requalification. Key documents included in the VMPs are user requirement specifications, impact assessments, risk analyses, traceability matrices, qualification plans and reports, deviation reports, and final reports.
In addition to Validation Master Plan services, BPV offers assistance with validation throughout the entire lifecycle of equipment and systems. Our full validation package can be customised to suit client needs and typically includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Equipment Specific Development Testing, and Requalification packages.
