Data Integrity and ALCOA+ Governance SOP
ALCOA+ compliance and audit trail review.
4 000 Skr
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Purpose:
This SOP defines the governance, responsibilities, and controls required to ensure the integrity, reliability, and traceability of data generated, processed, reviewed, and retained within GxP activities, in accordance with ALCOA+ principles.
Regulatory Alignment:
EU GMP documentation and data integrity expectations, including principles outlined in regulatory guidance from EU authorities and international inspection bodies.
Included Files:
• SOP – Data Integrity and ALCOA+ Governance
• Data integrity risk assessment template
• Audit trail review and data integrity checklist
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical companies, marketing authorisation holders, manufacturers, distributors, and quality assurance teams responsible for data governance and data integrity oversight.