Oakdale MN, April 20, 2008 – Pace Analytical Life Sciences (PLS) reached several milestones over the past few months in regards to regulatory accreditation and audits.
In February of 2008 PLS successfully added new methods to the existing scope of ISO 17025 accreditation. In addition, PLS successfully hosted a re-accreditation audit in support of the requirements of international standard ISO/IEC 17025, demonstrating “technical competence in the field of testing.”
The ISO audit was followed by a four-day, combined FDA Pre-Approval Inspection (PAI)/General Inspection audit performed during the first week of March, 2008. The result of the FDA visit was one FDA 483 observation, which was addressed prior to the close of the audit. Copies of the EIR will be available to PLS clients upon request.
Following these two audits Gregory Kupp, VP/COO of Pace Analytical Life Sciences, commented, “We were extremely pleased with the success of our two most recent regulatory audits, which confirms the fact that our Quality Management System can successfully withstand regulatory scrutiny and allows us to continue to confidently support the pharmaceutical and medical device industries with their testing needs”.
Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industry. Services include methods development/validation, raw material testing, stability testing and storage, product release testing, chemical characterization, and residual chemical analysis. Questions about service offerings can be directed to Jim Wheeler at (651) 294-0807.