Pharmaceutical Computer System Validation and Regulatory Compliance
It'sQA provides experienced consultants in IT security and Computer System Validation (CSV) for the pharmaceutical industry to ensure the systems used are validated to meet the predicate rules (GxPs) and comply with the requirements for electronic records and signatures.
We can support you throughout all stages of the system validation life cycle by using and adopting methods that suit your organisation. This includes applying a risk-based approach in line with current GAMP guidance.
Our experience extends to a number of functional areas that include GMP, GCP, GLP, 21 CFR Part 11, documents and records management, infrastructure and data centres.