Graphic: PENSA Technology Solutions Inc.

Graphic: PENSA Technology Solutions Inc.
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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.
 

VQA Level Fees(US) PENSA Service Provided PENSA Benefit Provided
Level 1 $10,000 annually, includes one re-audit per year. Completion of one time on-site audit and semi-annual re-audit Exceeds current industry requirements to solve today's problem. Reuseable audit report supplied by PENSA.
Level 2

$30-50,000

plus $10-15,000per annual review.

Royalties to PENSA $5-10,000 for resale of audit dataset.

Level 1 service in addition to support to clients (with vendor approval). Audit dataset is maintained by PENSA. Full service package for the validation effort is an option.

Level 1 benefit in addition to a unique validation audit dataset. Full service package to complete the validation effort avoids tying up valuable team resources.

Level 3

$75-100,000 (negotiated)

Full implementation package by PENSA $75-100,000 (negotiated)

Level 2 service in addition to PENSA's validation software and datasets prepared by PENSA, which are available for resale to vendor's clients.

Level 1 and 2 cumulative benefits in addition to PENSA's validation software application, TVM, the Validation Manager and corresponding audit datasets giving the vendor the ability to maintain compliance themselves, if they wish.

'PENSA Certification' noted on PENSA and partner websites.

Level 4

Pricing negotiated

Level 3 service in addition to integrated software solutions and joint development efforts.

Levels 1 - 3 cumulative benefits in addition to a collaborative effort between PENSA and the vendor toward a uniquely integrated and re-branded software solution to meet client needs.

 

E-mail Sales@PENSA.ca to request more detailed information.

Artificial knee joint image Zimmer Inc. Used by permission only.

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