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.
