04. Users Team Role in Computer Validation

Sometimes users describe a “requirement” but can’t figure out how to “test” for that requirement. In this case they have described a “wish” and must rethink their description until they can figure out how to test for what they are asking. There must be no “wishes” in a URS. …Developing a well-considered URS is the first step in the successful purchase of a new GXP system. (40)

The manager “owning” the regulated work process to be computerized is the GXP System Sponsor. This Sponsor has three roles to fill for the core of the user validation team – Team Leader, Test Coordinator, and Package Manager. The first team agenda is the User Requirements Specification (URS) and the second is to write a Validation Plan.

The success of the purchase, implementation, and validation of a GXP system begins and ends with the strength and completeness of its URS. The more care and attention put into the requirements by users who are know the regulated work process, the more usable will be the system purchased and the more successful the validation package in audits and inspections. A thorough analysis is needed of the user’s work process prior to the new system, how work is expected to change going forward, and what the new system needs to do in the work process for control and data handling activities.

Creating the URS requires a sharp work process focus and NOT a technical IT view. Once the work needs have been defined in user terms, then an IT person can discuss technical options and opportunities to meet those user needs. The URS will be refined in several rounds and during the purchasing process.

Simple three column WORD tables can be used to structure the URS with uniquely identified descriptions and user testing topics. Separate tables can be used to describe each phase of the work process, relevant regulatory needs, related equipment connectivity, and infrastructure requirements. Tables are useful because they can convey lots of information in a clear, concise manner with unique IDs that facilitate traceability to assure that all URS items are delivered and tested.

Next Month: The Auditable Computer Validation Package

People often ask why they need to have a Validation Plan if they already have a Test plan or vice versa…. Formal testing can be a complex and detailed activity and it does need a Test Plan of its own. There are, however, two other workflows to an auditable validation package and they need direction form an approved Plan as well. Thus there is a need for an overall package plan. (65)