Streamline CAPA Management with INQ: The Power of CFR 21 Part 11 and Annex 11 Compliance

Effective Corrective and Preventive Action (CAPA) management is the backbone of quality and compliance in regulated industries. Ensuring that your CAPA processes align with regulatory standards is paramount. At QikSolve, we bring you a powerful solution: CAPA management software configured on SharePoint, designed to meet the stringent compliance requirements of CFR 21 Part 11 and Annex 11. Let’s explore how we leverage the best practices of Microsoft SharePoint to streamline CAPA management and ensure compliance with ease.

The Challenge of CAPA Management

Corrective and Preventive Actions (CAPA) are essential in addressing non-conformities, improving processes, and preventing their recurrence. However, managing CAPA effectively in a regulated environment presents several challenges, including data security, electronic records, and electronic signatures.

CFR 21 Part 11 and Annex 11 Compliance

  • CFR 21 Part 11: This regulation by the FDA outlines the requirements for electronic records and electronic signatures, including CAPA records and signatures.
  • Annex 11: Annex 11 of the EU GMP guidelines focuses on computerized systems, including CAPA management systems, and emphasizes validation and data integrity.

QikSolve’s Solution: SharePoint CAPA Management Software

At QikSolve, we have a proven track record of configuring SharePoint to meet the compliance requirements of CFR 21 Part 11 and Annex 11, making it a robust platform for CAPA management:

1. Electronic Records Management:

  • Configure SharePoint to ensure that CAPA records are secure, unalterable, and accessible only to authorized personnel.
  • Implement detailed audit trails to maintain data integrity and traceability.

2. Electronic Signatures:

  • Set up SharePoint to facilitate electronic signatures for CAPA records in compliance with CFR 21 Part 11.
  • Ensure that electronic signatures are unique, verifiable, and compliant with regulatory standards.

3. Access Controls and Permissions:

  • Define and implement access controls and permissions within SharePoint to restrict access to sensitive CAPA data.
  • Align user roles and permissions with compliance requirements.

4. Data Validation and Integrity:

  • Establish data validation rules within SharePoint to prevent data entry errors and ensure the integrity of CAPA records.
  • Configure validation checks to meet GMP standards.

5. CAPA Workflow Automation:

  • Design and implement CAPA workflows in SharePoint to automate the initiation, investigation, and resolution of CAPA requests.
  • Ensure that workflow steps are compliant with regulatory requirements.

6. Training and Documentation:

  • Provide training to SharePoint users on CAPA compliance and best practices.
  • Maintain comprehensive documentation of SharePoint configurations for validation purposes.

Benefits of SharePoint CAPA Management Software with QikSolve

  • Efficiency: Streamline CAPA processes, reduce errors, and enhance collaboration among teams.
  • 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 CAPA records and signatures.
  • Cost Savings: Optimize resource allocation and reduce compliance-related costs.
  • Validation Support: Our comprehensive documentation supports the validation process, ensuring compliance and audit readiness.

Conclusion: Elevate CAPA Management with INQ

Effective CAPA management is vital for ensuring product quality and regulatory compliance. QikSolve’s CAPA management software, configured on SharePoint in accordance with CFR 21 Part 11 and Annex 11, empowers your organization to streamline CAPA processes while maintaining strict compliance. Contact us today to discover how we can transform your CAPA management with SharePoint.