The Atlas 2000 chromatography data system (CDS), developed and supplied by Thermo LabSystems (Altrincham, UK), was implemented at Covance as an upgrade to the current CDS, Multichrom Version 2.0. Multichrom runs on a VAX minicomputer cluster using VMS as the operating system and, although it has proved a robust and reliable CDS for several years, it was thought necessary to upgrade the software. Multichrom was built using 'old technology' that was not adequate to meet the current and future expectations of Covance, and its validation was considered inadequate to meet modern standards. Also, because of the introduction of the US Food and Drug Administration (FDA) regulation 21 CFR Part 11 for electronic records and electronic signatures in August 1997,1 compliance with this regulation became a priority.
The introduction of a major new system into the company presented logistical challenges - the system needed to be implemented in a compliant manner following software development life cycle (SDLC) principles, whilst ensuring seamless integration into the operational areas to minimize the effect on ongoing projects (Figure 1). To deal with these issues, it was necessary to identify key personnel from across the site, to get high-level commitment to the entire validation process and to plan the validation by implementing in a phased approach by department.
Requirements gathering and system evaluation For the replacement of Multichrom, three systems were evaluated: Atlas (Thermo LabSystems), Millennium32 (Waters Corporation, Milford, Massachusetts, USA) and Chromeleon (Dionex Corporation, Sunnyvale, California, USA). Supplier assessment questionnaires were sent out to each of the vendors as part of this process. The responses to the supplier assessment questionnaires were retained as part of the SDLC documentation.