p2000 Validation Project
22/10/2008
ITS has made a major commitment to the life science and other regulated markets by introducing a validated version of its popular p2000 system. In a 12 month project, ITS has extended its Quality Management System to include validation based on the industry standard GAMP for computerised systems. ITS worked with ABB Life Sciences, a leading provider of validation services, in developing its policy, procedures and templates and applying these to three applications of the p2000:
The p2000 software has been refined, fully documented and extensively tested to give a well-defined and controlled product that meets the demands of the life science industry in general, and 21 CFR Part 11 regulation in particular. Test software has been added that enables ITS to perform automated regression testing, something that will greatly assist in future changes and customisations. A fully compliant security package for access control has been added as has an automated audit trail.
Emphasis has been placed on providing lifecycle documentation that meets the end user needs making the introduction of p2000 into regulated areas a straight forward task. ITS can now provide documentation such as qualification protocols and requirements traceability as part of their standard offering, thus smoothing the way for using p2000 for critical process operations.
This investment demonstrates ITS long-term commitment to the regulated industries and willingness to invest in its quality system and operations, something that should prove beneficial to all users of ITS systems.
More detailed information will be sent to readers in the regulated industries. If you have a specific queries on ITS’s validation project or quality systems, please contact :
Gary Bolton
E: gary.bolton@itoms.com
