Technical Training

Computer Systems & Software Validation

Objectives

This 3 day interactive course will give attendees the knowledge and skills they need to comply with European, US and Worldwide Computer Systems Validation requirements

The course is fully tutor-led and focuses on the practical implementation of Computer Systems Validation requirements. The course provides attendees with a well-thought-out approach and real-world implementation methodologies, to help achieve compliance and assure consistency of performance of computerised systems. The course addresses the use of software and computerised systems in QMS, production, testing and distribution. Risk Management of software and computerised systems, and scaling of validation effort in proportion to risk are covered in detail. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Data Integrity.

The course involves practical group exercises which take the learner through the entire validation cycle with comprehensive feedback from the course tutor throughout.

What will I learn?

• Identify the regulatory requirements for Computer Systems Validation,
• State the benefits of conducting Computer Systems Validation,
• Categorise software in accordance with GAMP guidelines,
• Apply the V Model to Computer Systems Validation,
• Design a Computer Systems Validation master plan,
• Write user requirements for software and computerised systems,
• Assess software and computerised systems risks,
• Identify the main requirements for Electronic Records and Electronic Signatures,
• Apply the FDA guidance on 21 CFR Part 11 to software systems,
• State the main Data Integrity requirements,
• Complete a software DQ,
• Write IQ test cases for computerised systems,
• Identify challenge tests for software systems,
• Write Software OQ, PQ test cases,
• Report on Software testing results,
• Leverage vendor documentation to minimise validation effort,
• Assist in ensuring that the validated state is maintained.

Content includes

DAY 1:

• The Need for Computer Systems Validation
• European and FDA Regulations and Guidance on Computer Systems Validation
• The latest FDA Guidance on Computer Systems Validation
• The GAMP Approach to Computer Systems Validation
• The V Model Approach
• Computer Systems Validation Planning - designing master validation plans
• Writing Computer Systems Validation Rationales

DAY 2:

• Requirements Specifications
• Application of Risk Analysis to Software
• Software Design Qualification
• Requirements Tracing – using the RTM to plan qualification testing
• Software Testing and Software Test Environments
• Application of Statistics to Computer Systems Validation
• Statistical Rationale for Samples Sizes

DAY 3:

• Electronic Records and Electronic Signatures
• Application of the FDA Guidance on Part 11
• Data Integrity and Computer Systems Validation
• Software Performance Qualification
• Leveraging Supplier documentation for off-the-shelf systems
• Validation Reporting - How to Report on Computer Systems Validation testing
• Maintaining the Validated State

Who should attend

Personnel in the Pharmaceutical/Medical Device/Healthcare sectors who need to gain a solid foundation in the principles of Computer Systems Validation in a regulated environment.

Upcoming dates:

No training dates available at the moment.