The challenge
A global healthcare corporation struggled to meet 21 CFR Part 11, especially Section 11.10 on controls for closed systems. Auditors flagged noncompliance in authority checks, device checks, written policies, system document controls and accounts, and operational system checks.
Fixing single gaps was not enough. The company needed one global reading of the regulation, applied the same way in every division. That meant winning management support and managing the rule's broad impact.
New compliance protocols also had to fit into existing corporate structures.
Our approach
- Secured executive sponsorship to drive the program from the top.
- Built a tailored remediation plan for each noncompliant Part 11 subsection.
- Wrote global corporate policies so every division applied the rule the same way.
- Ran training and awareness programs for staff at all levels.
- Deployed software tools for operational checks, authority checks and document control.
- Used structured project management across departments and locations.
- Set up regular audits and continuous monitoring.
Results
- Better compliance in the areas auditors had flagged.
- Stronger data integrity and security through tighter controls.
- Leaner compliance processes with higher efficiency and lower risk.