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The Latest from Our Expert Consultants

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QUALITY SYSTEM VALIDATION AS A JOINT VENTURE BETWEEN INTERNAL RESOURCES AND EXTERNAL EXPERTS

UPDATES, MERGERS, ACQUISITIONS, OH, MY!

Unless your Company is a startup, you already have an established Quality System in place.  So for most, Quality System improvement is an ongoing challenge.  Often the most substantial changes take place if a new Quality software is implemented, a major software upgrade occurs or as the result of a merger and acquisition or divestiture.

The typical IM/IT and Quality units of a regulated company employ a base staff tasked with maintaining current operations.  When a major software project is planned or if an acquisition occurs, it provides the company the opportunity to redesign processes to make them lean, efficient and more relevant to current business needs, but current staffing does not usually provide adequate resources.

Most companies seek external assistance to complete these milestone projects.  Whether it is a new software, an upgrade or consolidation of multiple systems, a team of qualified individuals are sought to facilitate and complete the effort.  The redesign of the processes is primarily built during the requirements gathering phase.   Often, Validation resources are not involved in the early stages of the Project and this is a serious oversight on the part of the business unit.

“CAN” AND “SHOULD” ARE DIFFERENT THINGS…

Consulting firms must do more than provide manpower.  In an effort to create an amicable relationship, some external resources become bobble heads – they shake their heads ‘yes’ to every design request.  This happens with resources who have intimate knowledge of what the software can do but lack experience with the industry.  It can also occur with beginners who work in silos, are tasked with strictly functional activities, are unfamiliar with the software and have no background in regulated industries.

Lack of business knowledge is not a roadblock provided the team consists of adequate resources who have a solid background with regulations AND validation as they apply to your industry.  For example, just because you CAN leave all fields unlocked to correct typo’s after a record is approved doesn’t mean you SHOULD.  This is where a validation compliance specialist can make a big difference over a basic validation resource.  A conceptual wide angle lens approach captures the overall picture.

LEVERAGE RESOURCES TO PROVIDE CROSS-FUNCTIONAL EXPERTISE AT MULTIPLE PHASE POINTS

A validation resource who is brought into the project solely to author test cases is at a distinct disadvantage to provide valuable feedback to the team.  Decisions made during the design phase are usually not communicated to the Validation team.  Business cases / Performance Qualifications (PQs) are a challenge to author because the process is not understood.  Frequently critical questions go unanswered - or worse - unasked.  The validation phase is the last chance you have to ensure your process makes sense, so inherent project knowledge at this phase is critical.

Consider validation specialists who have a first-hand knowledge of the software being implemented/updated as well as a working knowledge of your industry and bring them into the process during the design planning phase.   They can double as Business Analysts and help ensure the right decisions are made – and documented – up front.  This promotes the “Bigger Picture” attitude throughout the team.  This also eliminates last minute rework during Validation and immediate change controls after go-live.