Deviation, CAPA, and Change Control Forms
Forms for deviation/CAPA/changes.
1 200 Skr
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Purpose:
Provides standardised forms to support the documentation and management of deviations, corrective and preventive actions (CAPA), and change control activities within a GMP quality system.
Regulatory Alignment:
Aligned with EU GMP requirements for quality management systems, including deviation management, CAPA, and change control as described in ICH Q10 (Pharmaceutical Quality System).
Included Files:
• Deviation reporting form
• CAPA initiation and tracking form
• Change control request and assessment form
Format:
Microsoft Word or Microsoft Excel (fully editable)
Intended Users:
Pharmaceutical manufacturers, contract manufacturing organisations, quality assurance teams, and operational personnel involved in GMP quality system processes.