GAMP5 Computer Software Validation

Description

The main objectives of this course is to give attendees the ability to apply the GAMP® 5 approach to categorise software and hardware for a networked and configured computerised system. It defines the appropriate engineering and life cycle activities and describes the suite of documentation required to maintain the system in a validated state. The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as applied to Computer Systems Validation. It gives guidance on leverage and management of suppliers and outsourcing to reduce the validation effort. The validation of Excel spreadsheets and other small bespoke applications is also covered.

Prerequisites

This computer systems validation course is designed for those working within the Pharmaceutical and Medical Device Industries seeking training in the requirements of GAMP5 and who need to gain a solid foundation in the principles of Computer Systems Validation in a regulated environment

Learning Objectives

Upon completion of this course; participants will be able to:
 

• To understand the bigger GMP picture, and see where Computer System Validation and GAMP5 fit in the overall picture
• To apply GAMP 5 concepts to Computer and software systems that need validation
• To apply a risk based approach to software validation
• To scale validation based on risk to patient safety, product quality & data integrity
• To write the main documents required to validate software e.g. URS/FDS/SDS, IQ/OQ/PQ Protocols, Reports.
• To leverage supplier involvement and reduce re-work
• Generate the key software validation documents needed to implement and maintain the validated state

Course Content

• The history of GAMP, the key concepts of GAMP 5 and Computer Systems Validation
• Introduction to GxP’s (Good Manufacturing Practice, Good Laboratory Practice etc.)
• General principles of validation, and it’s relationship to GAMP.
• V-Model and how to apply it to software
• Assigning categories and the associated validation effort
• Risk based approach to reduce validation costs
• The types of testing to consider
• The main design documents of the CSV life-cycle i.e. URS, FDS and SDS.
• The main qualification documents of the CSV life-cycle including IQ, OQ and PQ protocols
• Exercise: Writing URS, FS, DS & Test Cases
• Good test practices
• Good documentation practices
• Good Engineering Practices, and how to leverage Engineering activities in the validation phase.
• System Level Impact Assessments
• Component Level Impact Assessments
• Management of outsourcing
• Audit and leverage of suppliers
• Electronic Records and Signatures
• 21 CFR Part 11 compliance
• 21 Part 11 compliance for legacy systems
• Special interest topics e.g. Manufacturing Execution Systems and Electronic Batch Records, spreadsheets, Patch management, outsourcing, organisational change.