Computer Systems Validation in the Pharmaceutical Industry (2003)

Industry is becoming increasingly dependent on computerised systems and the healthcare industry is no exception. With the rapid technological advancement in this sector, there is a requirement for evaluation and validation of existing IT systems and for out-dated systems to be phased out and replaced by those with improved performance and reliability. The quality of electronic systems for laboratory and clinical use is carefully regulated and there is a need to gain a greater understanding of what if required by the regulatory bodies such as the FDA and GMP.

This conference will aim to take on the challenge to today’s healthcare industry, to develop practical solutions for integrating the quality assurance of computerised systems and electronic data into everyday business operations. The conference will bring together information directors, software project managers, application users, IT/IS installing teams and quality assurance professionals in the pharmaceutical and biotech industries. Presentations and discussions will assess current problems in computer validation and put forward possible solutions to allow for the successful integration of IT and life sciences in 2003 and beyond.

Previous attendees Pfizer AstraZeneca Novo Nordisk Ipsen International Amgen Berlex Laboratories Celltech Siemens Schering Steripak PricewaterhouseCoopers Eutech Engineering Solutions Investec Asset Management Q-One Biotech Limited Oxford Asymmetry International CB Technologies

Key issues include Establishing clear and unambiguous requirements GAMP 4 guidelines Improving understanding of the requirements of 21 CFR Part 11 Practical implementation of 21 CFT Part 11 at the user site Preparing for computer system audits Improving communications between supplier and client Validating legacy systems The roles and responsibilities of OQ,IT dept, IQ and PQ Assessing the impact of software changes Process excellence in validation life cycle Increasing efficiency of software validation Back up and securing of data and applications The role of cryptography in securing electronic data Electronic devices and computerised systems in clinical trials