A global healthcare corporation faced significant challenges in complying with 21 CFR Part 11, especially section 11.10 that deals with electronic records and controls for closed systems. Notable noncompliance issues were identified in key areas such as authority checks (11.10(g)), device checks (11.10(h)), written policies (11.10(j)), system document control and accounts (11.10(k)), and operational system checks (11.10(f)). SQA Solution was engaged to address these challenges and ensure compliance.
The Solution by SQA Solution
- Management Support: Secured top-level executive support for the initiative, emphasizing the importance of compliance for business continuity and integrity.
- Customized Compliance Approach: Focused on specific noncompliance areas, developing a tailored strategy for each subsection of 21 CFR Part 11.
- Global Policy Development: Created comprehensive corporate policies to address global compliance requirements, ensuring uniformity across all divisions.
- Training and Awareness Programs: Initiated extensive training programs for employees at all levels to foster a culture of compliance and awareness of regulatory requirements.
- Advanced Compliance Tools: Implemented software tools specifically designed to assist with compliance in the identified areas, enhancing operational checks, authority checks, and document control.
- Effective Project Management: Adopted a structured project management approach to oversee the implementation process across various departments and global locations.
- Ongoing Compliance Monitoring: Established a system for regular audits and continuous monitoring to ensure sustained compliance and address any emerging challenges.
