A specialized audit checklist for evaluating GMP compliance in pharmaceutical computerized systems validation, ensuring data integrity, system reliability, and regulatory compliance in electronic records management.
GMP Computerized Systems Validation Audit Checklist
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About This Checklist
In the modern pharmaceutical industry, computerized systems play a crucial role in managing manufacturing processes, quality control, and data management. This GMP Computerized Systems Validation Audit Checklist is an essential tool for evaluating compliance with Good Manufacturing Practice (GMP) standards in the implementation, validation, and maintenance of computerized systems. It addresses critical aspects such as system lifecycle management, data integrity, access controls, and change management specific to computerized systems. By systematically assessing these areas, pharmaceutical companies can ensure the reliability and accuracy of their computerized systems, maintain data integrity, and comply with regulatory requirements for electronic records and signatures.
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Select the compliance status based on the current lifecycle stage.
Attach or describe the validation documentation.
Enter the risk assessment score.
Select the date of the last review.
Select the backup status of the data management system.
Confirm if access controls are implemented.
Provide a detailed description of the training program.
Enter the average response time in hours.
Select the compliance status of the electronic records.
Confirm if audit trail functionality is implemented.
Provide a detailed description of the user access management policies.
Enter the average number of downtimes per month.
Select the status of risk assessment procedures.
Confirm if regular risk reviews are conducted.
Attach or describe the mitigation strategies.
Enter the risk acceptance threshold score.
FAQs
The checklist covers system development lifecycle, validation documentation, user requirements, functional specifications, risk assessments, testing protocols, data integrity controls, and system maintenance procedures.
It includes specific items to verify implementation of ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) in electronic records management.
Yes, the checklist is designed to audit validation processes for both custom-developed software and commercial off-the-shelf (COTS) systems, with sections addressing the specific requirements for each type.
It's recommended to conduct a comprehensive audit annually, with more frequent reviews when implementing new systems or making significant changes to existing ones.
The audit team should typically include IT specialists, quality assurance personnel, validation experts, and end-users or process owners of the systems being audited.
Benefits of GMP Computerized Systems Validation Audit Checklist
Ensures comprehensive evaluation of computerized systems used in GMP-regulated environments
Helps identify and mitigate risks associated with computerized system failures or data integrity issues
Supports compliance with 21 CFR Part 11 and other relevant regulations for electronic records
Enhances overall data reliability and system performance in pharmaceutical operations
Facilitates continuous improvement in computerized system management and validation practices