Gilles Tremblay and Spencer Andrews
Its value in the pursuit of regulatory compliance
One of the most critical challenges facing today’s research
facilities is the acquisition of regulatory compliance—that
stamp of approval that defines an institution as highly
qualified, safe and desirable for the demands and challenges
of complex and highly technical research. The inability to
acquire regulatory compliance can affect a lab’s capacity
to procure needed funding, conduct regulated work and
attract top tier researchers. Lack of licensure can also push
a research lab to the back burner of the industry, thus
impacting its future viability as a recognised scientific
It’s anticipated the licensure process will become more
complex as well. Demand for qualified, high containment
research facilities is increasing as human, plant and animal
populations are impacted with expanding and changing
disease forms. It’s one of the many challenges being faced in
the industry today.
To acquire licensure in this ever-changing environment,
institutions are devoting valuable time and resources to
the regulatory process with solutions to improve that
process being sought from many directions and sources.
One approach quickly gaining acceptance is the use of a
highly purposeful and rigorous, two-tiered commissioning
(Cx) verification and validation (CVV) program. This process
(CVV) provides a second tier of monitoring, assessment,
evaluation and recommendations above and beyond the
traditional Cx process.
WHAT IS CVV?
CVV is the combined activities of two independent steps.
1. Verifying that the Cx process has been completed
to the best practice performance standards in the
2. Validating the planning, design and operations of the
facility to ensure it was designed and built as planned
and is fit for intended use.
The activities of the traditional Cx process have been
in use for a considerable time and in some instances is
delivered by the contractor. However, CVV is bringing a new
paradigm to the industry. CVV combines the protocol of
verifying the Cx of a qualified system with the more robust
approach of validation (qualification). It provides a second
set of eyes on the project and a viewpoint independent of
the Cx/contractor role; a viewpoint that is committed to and
usually contracted directly by the client.
In addition, CVV can go well beyond the Cx model
traditionally used in Food and Drug Administration-approved
facilities and the pharma industries. The CVV approach is
moving the needle in the direction of ASTM E2500, which
relies more on subject matter expertise in commissioning
laboratory settings and focuses on product (laboratory
output) quality and user/environmental safety.
WHAT ROLE CAN ASTM E2500 PLAY IN CVV?
ASTM E2500 can play a major role in CVV. Per
Pharmaceutical Engineering Magazine, for many years, a Qualified
system meant that there existed a QA pre-approved,
executed and QA post-approved set of documents consisting
of an IQ and OQ (and in many cases a PQ) protocol. What
mattered was whether the local procedure was followed to
develop, execute and approve each protocol.
ASTM E2500 goes beyond that by stating that verification
is “a systematic approach to prove that Critical Elements,
acting singly or in combination, are fit for intended use,
have been properly installed, and operating correctly”. It
extends beyond traditional Cx and the V model by stating
that “the extent of verification and the level of detail of
Verification vs Validation