by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title …
CSV & Part 11 Compliance
Enforcement of Part 11 and Annex 11 varies, but electronic data integrity is something that cannot be compromised. Our experienced Part 11 team has tackled many firsts in the industry, for example, iPad apps and cloud-based systems.