Monday, November 4, 2013
The sponsor of a system and its validation package is the work process manager responsible for the regulated electronic data being processed. This is the manager who will meet with FDA inspectors to get their 483 report following a site inspection. (p. 35)
The Sponsor of the GXP software application is the end user manager or department head of the regulated work process using the system. When more than one department or facility is using the same GXP system, then often a council of managers representing all relevant departments is formed to provide “due diligence” management control of the strategic GXP system. Sometimes a Sponsor Council is formed as a Business Decision Group to address multiple systems with a specific regulated focus such as GLP or GCP, or GMP systems at a specific site or company.
The key idea is that the system Sponsor is someone or some group with the business responsibility and authority to commit budget, time, and user resources to the validation and ongoing compliance of the GXP system. The Sponsor role is to assure that the system performs its intended GXP function up to the goals of the organization and the standards of relevant regulations. If the system crashes, the Sponsor’s business process crashes, so the system Sponsor has a dedicated self-interest to assure that the system performs as intended in a reliable manner over time.
Sponsors need to understand that even for GXP SaaS applications in the cloud; an end user performance qualification (PQ) validation effort is still required. To accomplish this, the Sponsor assigns a Validation Team Leader to project manage the validation effort. The best Team Leaders are chosen because they clearly understand the GXP work process and data flow requirements and their own business role relies on reliable performance of the new system.
The Sponsor approves a PQ Validation Plan that defines personnel and deliverables in a timeline to give the Sponsor a clear view of what resources are needed and for how long. Sponsors need to back-fill the positions of validation team members with temporary relief from normal duties so that validation work can be accomplished in an efficient manner. It is tough for Sponsors to put some of their best people on validation teams and endure weeks of back-filled substitutes during the validation project, but this is the most cost-effective way to implement a validated system that really works well in production from day one. An added benefit is the cross training of the backfills. Providing the team with the added resource of an internal or external experienced validation coach can also provide efficiencies.
System validation work takes large chunks of concentrated effort and cannot be done in a few hours twice a week. Writing requirements, developing work process based test strategies, writing test scripts, preparing training materials, SOPs, and Work Instructions are time-consuming tasks. A large database system such as a clinical data management or pharmacovigilance application can be validated by a dedicated team in 90-100 work days. A team forced to work sub-rosa around an already full time work assignment can take nine months to a year or more to complete the same validation.
Next Month: Developing a Good User Requirements Specification (URS)
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. (p. 40)
Posted by Dr. Teri Stokes at 7:22 AM