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Gmp Compliance

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title: Is SharePoint GMP Compliant? How QikSolve Sets the Standard date: '2023-09-22' author: QikSolve category: GMP tags: gmp, sharepoint, cfr-21-part-11, annex-11 excerpt: How QikSolve configures SharePoint electronic records, signatures, access controls, and validation to meet GMP compliance requirements.

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!"

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.

QikSolve's Approach to SharePoint GMP Compliance

  1. Electronic Records Management — secure electronic records, accessible only to authorized personnel, with robust audit trails to track changes and maintain data integrity.
  2. Electronic Signatures — enable electronic signatures that meet CFR 21 Part 11 requirements using the INQ platform, unique to the individual and traceable back to the signer.
  3. Access Controls and Permissions — define granular access controls aligned with GMP compliance requirements.
  4. Data Validation and Integrity — establish data validation rules to prevent entry errors and ensure integrity according to ALCOA+ principles.
  5. Document Version Control — robust version control mechanisms with archived, accessible previous versions.
  6. Training and Documentation — train SharePoint users on GMP requirements and maintain comprehensive configuration documentation 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.
  • 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 — comprehensive documentation supports the validation process.

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. Contact us today to discover how we can configure SharePoint to meet your specific compliance needs.