PTSM: Pharmaceutical Technology Sourcing and Management
Regis Technologies passes a recent FDA audit with no Form 483 observations.
Regis Technologies, which provides synthesis, separations, and manufacturing services to pharmaceutical and biotechnology companies, reported that it passed a recent FDA audit with no Form 483 observations. Regis’ GMP manufacturing facility, QC laboratory and quality systems were part of the detailed compliance inspection. The company reports that it was the second consecutive audit without a Form 483 observation. Regis operates a 36,000-sq ft facility that includes laboratories and production capabilities with eight dedicated reactor suites, individual kilo lab suites, a cryogenic reactor, and a quality control department. The company has regulatory approvals in 20 countries across the globe.
Source: Regis Technologies
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.