Fix My Systems Compliance
What You Are Dealing With
Your computerized systems touch nearly every critical process in your GMP environment, and the FDA’s expectations around validation, data integrity, and audit trail compliance are specific and getting stricter. Whether you are implementing a new system, preparing for an inspection, or trying to close gaps that have been sitting on the list too long, the work is technical, time-consuming, and hard to resource internally without pulling your team off everything else. Unvalidated systems and data integrity gaps are among the most common triggers for 483 observations. You need someone who knows exactly what the FDA looks for and can get it done.
How We Approach It
We assess the state of your computer systems and data integrity controls, identify where the gaps are relative to FDA expectations, and build and execute the validation and remediation work required to close them. We cover CSV, CSA, 21 CFR Part 11, data integrity, LIMS qualification, and IT quality management across systems of every size and complexity.
What We Have Done
A pharmaceutical manufacturer engaged MEDVACON to develop a comprehensive validation plan and data integrity strategy for their QA laboratory spreadsheets, ensuring full version control, security, and validation. MEDVACON deployed CSV and data integrity analysts to verify compliance across all datasets. The client moved through FDA review with no CSV or data integrity issues identified.
A specialized testing laboratory engaged MEDVACON to assess cGMP compliance at their facility, with a focus on computer controls and processes. MEDVACON assisted in migrating the client from manual closed-loop systems to a cloud-based platform and developed both a Data Governance Policy and Data Integrity Policy. The client retained MEDVACON for ongoing consulting work following the engagement.