Tuesday March 22, 2016
Compliance management is a vital process within the pharmaceutical and life science industries. Due to rapidly evolving regulatory changes, companies do not want to risk making mistakes in these fast-paced and market driven industries. Regulatory compliance and quality assurance is also important because fines, audits, recalls, etc. cost life science companies billions each year.
According to various FDA Warning Letters, here are some examples of common compliance mistakes in the pharmaceutical and life science industries:
- “Failure to adequately validate according to established procedures.”
- “Failure to review and approve design output before release.”
- “Failed design validation that ensures the medical device conforms to defined user needs and intended users.”
- “Failure to adequately establish procedures for acceptance of incoming product.”
- “Failure to follow an established procedure for Change Control or following an established Change Control procedure that has not yet been approved”