Focus Compliance & Validation Services2018-08-02T21:30:57+00:00
Welcome to Focus Compliance & Validation Services
Core Regulatory Compliance & Validation Services
Focus Compliance & Validation Services provides consulting services to assist our clients in achieving and maintaining FDA regulatory compliance. Our core areas of expertise include: computer system validation; quality system development, implementation, maintenance, and auditing; response to agency actions including 483s and warning letters; FDA mock inspections and mock recalls; training; risk management; process validation and equipment qualification; and related assistance. We have experience providing these services in the medical device, pharmaceutical, and biotech industries.
Computer Systems Validation
Medical Device Industry
Pharmaceutical Industry
Regulatory Affairs/GXP Compliance
Blood and Plasma Industry
Pharmaceutical Packaging Industry
Focus Compliance & Validation Services is located at 4700 Papermill Drive in Knoxville, Tennessee.

Be The Match, a Global Leader in Bone Marrow Transplantation, is a client of Focus Compliance & Validation Services

For the thousands of people diagnosed every year with life-threatening blood cancers like leukemia and lymphoma, a cure exists. Over the past 30 years Be The Match ® , operated by the National Marrow Donor Program ®  (NMDP), has managed the largest and most diverse marrow registry in the world.  They work every day to save lives through transplant.

Thanks to Mike Mushaw, a college football player, a little girl’s life was saved. Click the link to read the story:


Emergency Use Authorizations for the Decontamination of N95 Respirators – Webinar Recording Available Now

The U.S. Food and Drug Administration has issued emergency use authorizations for select sterilization systems that will allow N95 or N95-equivalent respirators to be decontaminated. The sterilization systems will help address the shortage of these vital masks used by healthcare workers to protect themselves from exposure to the novel coronavirus.


This May 4 webinar featured an expert from 3M who addresses the 3M perspective on the decontamination of N95 respirators and shares important caveats about doing so, as well as representatives from STERIS, Battelle, Advanced Sterilization Products (ASP), and Sterilucent, each of whom have systems covered by EUAs. Following the expert presentations, is a Q&A session.


Systems covered under EUA that will be addressed include:

  • STERIS: STERIS V-PRO 1 Plus, maX, and maX2 (Low Temperature Sterilization Systems)
  • Battelle: Battelle CCDS Critical Care (Decontamination System)
  • ASP: STERRAD 100S, NX, and 100NX (Sterilization Systems)

Sterilucent: Sterilucent HC 80TT Hydrogen (Peroxide Sterilizer)

For recording: