Case Studies
21 CFR Part 11 Gap Analysis
Client
Bulk Chemical Manufacturer
Industry
Pharmaceutical
Business Challenge
Preforming gap assessments of quality software systems and laboratory systems
Project Timeline
6 Months
Challenge
In preparation for an upcoming FDA audit, a pharmaceutical-grade bulk chemical manufacturer engaged ÐÓ°ÉÂÛ̳ to conduct a comprehensive gap analysis assessing compliance with 21 CFR Part 11 requirements for Electronic Records. ÐÓ°ÉÂÛ̳ was tasked with evaluating eight quality software systems and twenty-nine laboratory software systems to identify gaps and ensure regulatory readiness.
ÐÓ°ÉÂÛ̳ Approach
ÐÓ°ÉÂÛ̳ designed a structured assessment strategy that included targeted interviews with key stakeholders for each software system to evaluate compliance with specific 21 CFR Part 11 requirements. A risk assessment was then conducted to identify high-risk systems based on their level of compliance. Using the results of this analysis, ÐÓ°ÉÂÛ̳ prioritized the software systems and developed a risk-based remediation plan to ensure full regulatory compliance across all platforms.
Result
ÐÓ°ÉÂÛ̳ presented the results of the gap assessment, risk analysis, and system prioritization to the client’s leadership team. Within a month, the FDA conducted an inspection and reviewed the assessment findings along with the remediation plans. Based on the thoroughness and clarity of the approach, the FDA concluded that the client had sufficiently demonstrated progress toward compliance with 21 CFR Part 11—and issued no regulatory observations.
