Background

In preparing for an upcoming 21 CFR Part 11 audit by the FDA, a pharmaceutical chemical manufacturer required a gap analysis. The goal of the chemical products company was to determine compliance of quality and laboratory software to requirements for electronic records.

Challenge

RCA was contracted to perform a gap analysis for software systems used by chemical suppliers. Eight quality management system (QMS system) and twenty-nine lab software systems were analyzed in the chemical factories based in USA.

Approach

Regulatory Compliance Associates^® Inc. developed a gap assessment strategy based on each unique chemical manufacturing plant. Client interviews were conducted based on specialty chemical manufacturing and each software system. A gap testing questionnaire was used with each level of manufacturing team member. 

Answers were reached to determine compliance with chemical manufacturing industry standards and specific requirements of Part 11. Then a risk assessment was performed to determine highest risk software systems based on compliance with Part 11.

Finally the gap analysis process prioritized each of the software systems based on the risk analysis. This prioritization was used to develop a data gap analysis and remediation plan to bring all software into compliance.

Result

The final gap analysis document results was presented to the chemical supplier company. It contained a detailed SWOT analysis and software gap analysis to prioritize work needed for the remediation plan. Each production facility had an individual remediation action plan and recommendations to reach regulatory compliance. 

Within a month of the gap assessment, the FDA revisited the client’s corporate headquarters. The Food and Drug Administration reviewed the findings and remediation plans. The FDA determined the client demonstrated a regulatory pathway to eliminate the non compliance. No additional regulatory observation was given and the FDA approved the client was in compliance with 21 CFR Part 11. 

 

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