Practical Training and Mentoring in Computer Systems Validation for Life Sciences companies and organisations.

Validation Overview

Here we tell you what you need to know. The course introduces the principles and concepts of computer systems validation (usually called CSV), enabling you to focus in on the areas of computerised systems that most impact patient safety, product quality and data integrity within your organisation. We can tailor the course to your requirements, but it is typically between a ½ day and a full day. The full day allows us to go more in depth into each of the topic areas and cover some real life lessons learnt (it’s quite often painful but worth listening too). You can use this course as the start of your learning to allow you to perform the work or use it so you have the knowledge to be able to pick the right person.

Change Management

This course covers the specialist topic of Change Management, a key process of good IT practice in any industry, but of particular importance in IT Validation. This course provides you with the knowledge to develop and apply a Change Management system to demonstrate control over changes made to computer systems, software, hardware and documentation. It considers the controls required during the computerised system development phase and the on-going change control process throughout a system’s life.

21 CFR Part 11

We have been heavily involved with Part 11 and the evolving regulatory and industry interpretation for many years. In this course we pass on to you some of the simple techniques we have used with our clients to help them achieve compliance. Remember Part 11 is about electronic records as well as electronic signatures, so we will help you get a better understanding of which records are within the scope of the ruling.

We also cover a risk based approach to the records within your organisation, how to manage your records, conduct Part 11 assessments and help mitigate any gaps in your systems or processes.

Dealing with the Retrospective Validation of Legacy Systems

This course deals with the application of the principles of validation to legacy computer systems. How to demonstrate that a system you have been using for years does what it is supposed to do and nothing else and how what and indeed whether to test during a retrospective validation exercise.

GAMP Testing, What and How

In this course we introduce you to a practical and pragmatic approach to testing based on a GAMP 5 approach. We will introduce you to the different types of testing and the difference between testing something and demonstrating you have tested something 3 years from now, to an auditor, when none of the IT people involved in the project still work for you. We might even throw in a few templates!

Network and Infrastructure Qualification

This course covers the practical and pragmatic approaches that we know can work to achieve Network and Infrastructure Qualification and the procedures to follow, to maintain the qualified status (which you worked so hard to achieve in the first place). These include Change Management, Configuration Management, Access Control, Backup, Disaster Recovery, Archiving and dealing with problems.