Developing a good URS requires high expertise in the work process to be computerized, not in the computer technology itself. (p.40) Developing a well-considered URS is the first step in the successful purchase of a new GXP system. (p.41)
The forte of IT is in knowing technology and the various types of system and software options that could be compatible with the infrastructure currently installed at a user’s location. IT staff do not know the specific details of the many regulated work areas they support. Only people working in the specific area can know the distinct requirements of their particular workflow and data handling activities and their applicable regulations.
Managers looking to replace a current system with a different one or move from manual to computerized operations are often reluctant to put their best people on the team to write a User Requirements Specification (URS). They see the URS as an IT task when in fact the exact opposite is true. It is a work process task to define the URS for getting the best return on investment for GXP systems, e.g., the right system fit to the user’s work process and compliance to GXP regulations.
The major technical knowledge an End User needs is that required by his/her role in the GXP work process and the ability to make 3 column WORD tables. The first column is for unique identifiers for each requirement. The second column is for a title and brief description of the work process need. Then the third column is for a bullet list of work process based testing topics that can be used to check whether the system can deliver the requirement. An example from pharmacovigilance is given below.
Data Entry Function
PV Safety System Test Topics
|DEUR.01||Safety Case: System accepts the criteria for a safety case.||Enter identifiable Reporter, Event, Patient and Suspect Drug into a case. Printout a MedWatch form that incorporates these data.|
|DEUR.02||Case Template: The system supports replication of a new case from a template.||Set up a case & replicate/edit three times.|
|DEUR.03||Case Tracking: The system supports tracking of a case in the workflow.||Set up a case and check status in workflow.|
|DEUR.20||Role Security: The system supports a role-based security system.||Attempt cross role activities.|
Such a URS can easily be converted into a Trace Matrix by adding a fourth column to record the Test Script IDs used to test each uniquely identified requirement.
Next Month: What’s the hardest part of a Test Plan?
An approved Test Plan is essential to formal testing as it gives the scope and strategy for the whole testing effort…The IEEE Standard 829-1983 for Software Test Documentation provided a test plan outline that experience has shown to work for any testing effort and across all validation packages. (p.92)