Biotech, Pharmaceutical and Medical device manufacturers need to be meticulous in their development process and undergo strenuous verification. QualiTest has created a wide range of consulting services, using a team of domain experts, to deliver high quality solutions for the medical field:
- Computerized systems Gap Analysis
- System classification and deliverables determination
- Product and equipment risk assessment
- FDA validation
- cGMP/GAMP
- cGMP & Computer Validation Training
- Validation Master Plan (VMP) & Computer Validation Master Plan (cVMP) preparation
- Computer Validation Protocols preparation & execution
- 21 CFR Part 11 Risk Assessment and Gap Analysis, Assessing and developing 21 CFR Part 11 SOPs and test documents
- Validation Protocols preparation and execution (IQ/OQ/PQ)
- Development of Standard Operating Procedures (SOPs)
- Design Review of Construction & Critical Systems
- Verification & Validation of Processes & Equipment Required By HACCP
- Product and product line equipment Risk Assessment
- Construction of Pharmaceutical, Biotechnology Facilities Design Review
- Review of Engineering Files, Basis of Design for