BioQA Solutions, LLC

Industry Trend

Quality has become a focal point of cost-effective business management.

The attitude has shifted from quality systems
being seen as a luxury to a necessity
and proactive business objective.

 The most successful Biotech Start-Ups start with a Quality Plan

and Quality Manual!

Our Business

Typically large consulting companies charge sizeable fees for what seem to
be “universal template” procedures, plans, and training sessions.  

They may not  take into account how your business, and the regulations you are to comply with,
must not only assure the quality of your services/products, but also not
impede upon the efficiency or productivity of your company!  

Since its inception in 2004 as Lab Quality Resources, BioQA Solutions, LLC continues to focus on the relevant standards and regulations as they
apply to YOUR Biotech company and will provide tools (gap analysis, pre-
inspection/ remedial action plans, training, procedures) with YOUR business
in mind.

Whether your company has short term quality goals or is in need of a quality system
“make-over”, BioQA Solutions, LLC has the knowledge and proven experience
to take you to the next level.





Who We Are

The company was founded and is managed by Kristen Knezevich, ASQ-CQA, BA (Biology-UMBC).

Ms. Knezevich's vast experience includes over 30 years of veterinary, human
embryology, andrology, clinical endocrinology, bioassay development, cryotechnology, cGMP QC labs, biopharmaceutical QA, medical device QA, cryorepository QA with over 25 years in management roles.

Accreditation, certification and related inspection experience includes Food
and Drug Administration (FDA), ISO Notified Bodies including BSI and Intertek, American Society of Quality (ASQ) Foundation for the Accreditation of Cellular Therapy (FACT), Clinical Laboratory Improvement Act (CLIA), College
of American Pathologists (CAP), Joint Commission (for the Accreditation of Hospital
Organizations (formerly JCAHO), American Association of Tissue Banks (AATB), and American
Board of Bioanalysis (ABB).  

QA  and Quality Management System (QMS) experience includes medical device manufacturers in support of IDE, PMAs and 510K approved devices, contract
biopharmaceutical manufacturing, bioassay laboratory techniques and molecular biology laboratories.

Projects have included Quality System Plan development and execution,
validation activities and the development of medical device cGMP Quality Systems. Most recently successful upgrade and implmentation of ISO 13485:2016 systems.

This broad range of experience and success has been based on the same basic
Quality System principles that BioQA Solutions, LLC can customize to fit your
needs.