Recently, Augmentir completed a rigorous qualification audit as part of a Tier 1 Pharmaceutical Manufacturing company’s Good Manufacturing Practice (GMP), and we are pleased to announce that our product successfully passed the audit.
Recently, Augmentir completed a rigorous vendor qualification audit as part of a Tier 1 Pharmaceutical Manufacturing company’s Good Manufacturing Practice (GMP), and we are pleased to announce that our product successfully passed the audit.
According to the International Society for Pharmaceutical Engineering, GMP regulations require that pharmaceutical manufacturers adequately control manufacturing operations, and establish a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. The use of Augmentir’s connected worker software is a critical component for manufacturing within the pharmaceutical and life sciences environment as it helps to reduce errors and ensures compliance with these regulations.
This qualification audit, performed by our client’s Lead Auditor and the Senior QA Validation Specialist, assessed the adequacy and effectiveness for adherence and compliance to regulatory requirements. The quality and effectiveness and compliance to the site’s Quality Management System (QMS), policies, and procedures were also assessed and ultimately, Augmentir was approved to be an Enterprise IT System/Infrastructure Provider.
Audits like these are challenging for any company and can present even greater challenges for small companies like Augmentir. Yet, it is extremely important as GMP regulations ensure a quality approach to manufacturing, helping companies minimize errors, mistakes, and instances of contamination.
At Augmentir, we have successfully completed multiple audits to date and are excited to add this Pharmaceutical GMP Audit to that list as we continue in the steps of our legacy products. These audits aren’t new to our team, and this recent milestone is a continuation of our history in bringing innovative, high-quality software into the manufacturing sector, having delivered on more than an estimated 100,000 audited processes throughout the history of software products our team has been involved in.
As we kick off 2022, this Pharmaceutical GMP Audit completion stands as a testament to Augmentir, our team, and our commitment to maintaining the highest global quality standards and validates our success in the pharmaceutical industry.
Here’s to our next successful audit!