Field notes from the front line of quality.
Practical guidance from Globiox SMEs — FDA readiness, auditing, CAPA, validation, and quality systems for regulated life sciences.
Part 11 Compliance Is About the Environment, Not Just the Software
Written by: Patti Rossman A validated system with full audit trails can still produce records that fail 21 CFR Part 11. The software is only half of…
October 8, 2026AuditingStep-by-Step Strategies for Effective REMS Audit Preparation
Written by: Patti Rossman Preparing for a REMS (Risk Evaluation and Mitigation Strategies) audit can be a daunting task, but with the right approach, it can be…
June 27, 2024AuditingThe FDA’s “dos” and “don’ts” for responding to a 483
DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to…
November 13, 2013AuditingFDA 483: Does your business contain critical errors?
In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed…
August 22, 2012Ready to get inspection-ready?
Request an Audit Quote →
737.231.0233LinkedIn ↗TrackWise® is a registered trademark of Sparta Systems, Inc., a Honeywell company.Some illustrative imagery on this site is AI-generated.Payments are processed securely by Stripe.Privacy Policy · Terms of Service