PENSA's Vendor Qualification
Auditing
As
part of the due diligence, under the legally
mandated regulatory obligations, companies in the
Life Sciences industry must routinely audit a
software vendor's development process and
environment to assure that high quality standards
exist and are maintained. In situations where the
software vendor's process and environment are
inadequate, the software vendor may be rejected as
a vendor, or they may be required to make certain
changes to meet FDA cGMP Guidelines (current
Good Manufacturing Processes) before the software
can be purchased and used by the Life Sciences
client.
PENSA
has been providing audit services to software
vendors for several years. The VQA Program
formalizes these services into a program with a
range of options for the software vendors that are
attempting to sell into the Life Sciences. The
PENSA VQA certification provides software vendors
the ability to build a solid plan of business
development in the industry. By progressing through
VQA levels and certification, software vendors can
ultimately deliver exactly the right solution for
their customers including satisfactory audits as
well as support for the client's validation
process.
PENSA's
VQA Program is available to software developers in
four levels of increasing sophistication. A
software developer may elect to begin at the most
basic level (L1) and to remain at that level or
progress from one level to another. VQA level
selection is usually driven by market needs and
business goals.
