Validation. We show you the way it was meant to be.. easy!

Computer Systems Validation (CSV) has a bad press.. IT solutions in the regulated industries must be ever safer, reliable, secure and meet the provisions of advancing and progressing regulations. Whilst at the same time the expectations are that technology and software projects must be implemented within shorter project durations and rapidly demonstrate return on investment and lower total cost of ownership. To meet these conflicting pressures and since the early 1980's; Factorytalk consultants' led the formation of the industry wide group that developed internationally accepted CSV guidance known as the Good Automated Manufacturing Practice  guide (GAMP).

The GAMP guide is published through the International Society of Pharmaceutical Engineers (ISPE) and our Consultants have been responsible over the last 15 years as joint authors to constantly update, improve and enhance the body of work to incorporate regulatory updates and initiatives such as Risk Management. The latest release is the GAMP5 release and we will help you understand it and provide coaching or turnkey services to practically implement the best practices within your Quality Management System. We provide support across all stages of the lifecyle:

- Identify the most appropriate validation strategy

- Prepare computer validation plans, policies and procedures

- Provide templates for pre-qualification and qualification documentation

- Perform supplier audits

- Develop and execute test protocols

- Conduct IS / IT Gap Analysis studies

- Perform 21 CFR Part 11 assessments on systems

- Project manage implementation and upgrades of computerised systems

- Conduct training to suit your needs