Qualification & Validation
Our equipment qualification approach is in alignment with GAMP, ISPE, and ASTM E2500, whereby validation support activities and documentation focus on what is critical for end product quality and are scaled according to customer requirements based on risk and complexity.
- Installation and Operational Qualification of equipment, Process Qualification and Validation for consistency and repeatability, is of key importance in the biopharma industry.
- With a systematic approach to controlling the various stages of project life cycle from design, development, production to testing, every aspect of the project is well documented as per cGMP guidelines.
- We also perform Computer System Validation as per 21 CFR Part 11 guidelines.
Validation
Master plan
Installation
Qualification
Operational
Qualification
Documentation
Process
Validation
