In regulated industries like pharmaceuticals and life sciences, compliance with Good Manufacturing Practices (GMP) is non-negotiable. Ensuring that your document management system meets the stringent requirements of regulations such as CFR 21 Part 11 and Annex 11 is paramount. But can SharePoint, a widely used collaboration platform, be GMP compliant? At QikSolve, we answer this question with a resounding “Yes!” Let’s explore how we configure SharePoint to meet these compliance requirements and set the standard for GMP compliance.
Understanding GMP Compliance and SharePoint
Good Manufacturing Practices (GMP) are a set of guidelines and regulations that ensure the quality, safety, and consistency of products in regulated industries. In the pharmaceutical and life sciences sectors, GMP compliance extends to electronic records and signatures, a domain covered by CFR 21 Part 11 (issued by the U.S. FDA) and Annex 11 (issued by the EU).
SharePoint, with its robust document management and collaboration features, can be a valuable tool in achieving GMP compliance. However, proper configuration and adherence to best practices are essential. That’s where QikSolve steps in.
QikSolve’s Approach to SharePoint GMP Compliance
At QikSolve, we specialize in configuring SharePoint to meet the compliance requirements of CFR 21 Part 11 and Annex 11. Here’s how we set the standard:
1. Electronic Records Management:
- Configure SharePoint to ensure that electronic records are secure, accessible only to authorized personnel, and cannot be altered without proper authorization.
- Enable the robust audit trails to track changes to electronic records, maintaining data integrity using the security and compliance centre
2. Electronic Signatures:
- Set up SharePoint to enable electronic signatures that meet the stringent requirements of CFR 21 Part 11 using the INQ platform.
- Ensure that electronic signatures are unique to the individual and can be traced back to the signer.
3. Access Controls and Permissions:
- Define and implement granular access controls and permissions to restrict access to sensitive information.
- Ensure that user roles and permissions align with GMP compliance requirements.
4. Data Validation and Integrity:
- Establish data validation rules within SharePoint to prevent data entry errors and ensure data integrity according to ALCOA+ principles
- Configure data validation checks to meet GMP standards.
5. Document Version Control:
- Set up SharePoint document libraries with robust version control mechanisms.
- Ensure that previous versions of documents are archived and accessible when needed.
6. Training and Documentation:
- Provide training to SharePoint users on GMP compliance requirements and best practices.
- Maintain comprehensive documentation of SharePoint configurations for validation purposes.
Benefits of SharePoint GMP Compliance with QikSolve
- Regulatory Confidence: SharePoint configured by QikSolve meets the requirements of CFR 21 Part 11 and Annex 11, ensuring regulatory compliance and confidence.
- Data Integrity: Maintain the integrity and authenticity of electronic records and signatures.
- Efficiency: Streamline document management processes, reduce errors, and enhance collaboration.
- Cost Savings: Optimize resource allocation and reduce compliance-related costs.
- Validation Support: Our comprehensive documentation supports the validation process.
Conclusion: SharePoint GMP Compliance—Setting the Standard with QikSolve
SharePoint can indeed be GMP compliant when configured and managed correctly. At QikSolve, we go the extra mile to ensure that SharePoint meets the rigorous standards of CFR 21 Part 11 and Annex 11. Trust us to set the standard for GMP compliance in your organization. Contact us today to discover how we can configure SharePoint to meet your specific compliance needs.