SCOPE – WP7 Quality Management Systems

• SCOPE WP7 Quality Management Systems – Compliance and Performance: Management and Indicators (1937kb .pdf)

• SCOPE WP7 Quality Management Systems – Document and Records Management (2572kb .pdf)

• SCOPE WP7 Quality Management Systems – Survey Report: Interaction with Pharmacovigilance Inspectors (4122kb .pdf)

• SCOPE WP7 Quality Management Systems – Exchange of Information between PV Assessors and PV Inspectors: Best Practice Guidance (2721kb .pdf)

• SCOPE WP7 Quality Management Systems – Pharmacovigilance Quality Manual Template (37993kb .pdf)

• SCOPE WP7 Quality Management Systems – Quality Planning and Quality Objectives (2429kb .pdf)

• SCOPE WP7 Quality Management Systems – Quality Standards of Pharmacovigilance Assessment (1336kb .pdf)

• SCOPE WP7 Quality Management Systems – Survey Report: Understanding National Quality Systems (4633kb .pdf)

• SCOPE WP7 Quality Management Systems – Resource Management Best Practice Guidance (15469kb .pdf)

• SCOPE WP7 Quality Management Systems – Survey Report: Resource Management (4483kb .pdf)