Global Compliance for Computer Systems Validation - Mastering the Balance of Effectiveness and Efficiency with Risk and Compliance

Aims:
To provide an introduction to the data management systems with product and GMP impact (MES, LIMS, EDMS, ERP, MRP), and to develop a broad understanding of the scope of Good Automated Manufacturing Practices and Quality Management Systems applicable to drugs, devices and biologics.

Outline Syllabus: 

• Principles of Computer Validation as per USFDA part 11, PIC/S Annex 11 and ASTME2500.
• Understanding the GAMP 5 Approach to Computer Systems Validation (CSV).
• Data integrity and security measures (back-up, archiving and retention requirements)
• Electronic Records and Electronic Signatures.
• CSV Documentation and Testing.

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• Understand the requirements of the regulations and how they relate to the guidance documents and Good Automated Manufacturing Practices (GAMP5).
• Understand all stages of the software development lifecycle, and the activities, software quality assurance practices and documentation requirements in each stage
• Discuss data integrity and security measures required under International GMPs.
• Discuss the concepts of risk assessment.
• Understand the QA & IT terminology.
• Identify the requirements of computer system suppliers to the industry.

(2) Discipline skills

• Apply risk analysis to identify data management systems with product and GMP impact.
• Apply ERES principles to computer systems
• Audit data management systems to identify GMP compliance issues.
• Audit suppliers to determine GAMP5 compliance
• Prepare User Requirement Specifications for data management systems
• Prepare validation plans and protocols
• Prepare SOPs for securing data.