
Improving Compliance of FDA Validated System with Improved Data Governance for Pre-Approval Compound Testing
A case Study
Introduction
Our client, a large pharmaceutical company, is committed to maintaining the highest standards in drug safety and efficacy. To meet stringent FDA approval processes, to continually seek technological advancements in its quality testing protocols and required improved technical data governance to ensure compliance.
Client Background
Our client’s quality testing operations had governance processes that relied too much on human intervention and verification of controls. The FDA validated system in-scope was critical for testing compounds and occasionally had compliance issues stemming from governance processes requiring human intervention and oversight.
Challenges
Partially manual verification and validation processes experienced occasional error or delayed error detection.
Human Error
1
The data governance framework did not cover aspects that included manual verification and only covered the integrity of the data itself and not verification of processes and procedure results.
Data Governance
2
Results
By automating portions of the verification of processes, the need for human oversight was significantly reduced while monitoring of data and tracking of process results helped, leading to fewer errors and discrepancies in data.
Reduced Human Intervention
1
The new data governance protocols ensured better management of process-related data throughout the verification of processes, from data collection to analysis and oversight, ensuring greater consistency and reliability.
Strengthened Data Governance
2
The updated processes and data governance standards showed a marked improvement in compliance rates during subsequent FDA audits, with fewer citations for data management and process control issues.
Enhanced Compliance
3
By enhancing data governance and reducing reliance on manual processes through automation our client significantly improved compliance in FDA-validated systems used for pre-approval compound testing. This approach not only meets regulatory requirements more effectively but also supports the company's commitment to drug safety and efficacy.
Conclusion
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Consulting Approach
Our consulting firm worked with stakeholders on a detailed approach to address the client's challenges and implement updates to data governance strategy:
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Conduct a comprehensive audit of the existing quality testing of verification processes and procedures to identify weaknesses in data governance in regard to validation of control mechanisms and process completion.
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Verification processes and the associated data from those processes were identified along with gaps in the process outputs.
Assessment & Analysis
1
Verification processes were re-designed to reduce the need for manual oversight and increase the accuracy and reliability of test results by ensuring process results from verification were properly captured or added to processes.
Design of Automated Verification
2
Provide extensive training for all relevant personnel on the updated processes and process verifications to ensure proper oversight and adherence to compliance standards.
Training & Development
3
Establish a schedule for regular reviews of data testing results and handling of process verification issues to ensure it remains compliant with evolving FDA regulations and standards.