Avara Responds Faster To Audits and Eliminates 100% of Lost Document Issues with ZenQMS
Avara Pharmaceutical Services, Inc., based in Norwalk, Connecticut is an international pharmaceutical services company that delivers world class contract manufacturing and technical services to the pharmaceutical industry. The company’s broad experience with supply chain, commercialization, product launch, and product transfer enables them to maintain exemplary levels of product quality and regulatory compliance.
The team at Avara believes that by integrating quality into their operational excellence programs, they will reduce waste and increase customer satisfaction. Given their commitment to delivering on-time and on-price for their clients, they cannot afford to be slowed down by regulatory and compliance obstacles.
In addition to being audited regularly by the FDA, Avara is also audited by their clients who include global pharmaceutical brands GlaskoSmithKline and Johnson & Johnson. Hence, it is critical that their team have access to a quality management system (QMS) that aligns with their business promises.
Prior to implementing ZenQMS, Avara managed quality via a combination of manual systems and legacy software solutions. The manual nature of their systems led to frequent missing documents and delays due to physical and electronic files being misplaced.
"Thanks to ZenQMS, my team is now able to quickly and accurately respond to audit inquiries and the error rate is significantly lower than with our prior quality management system.”
Heather Faber, Regulatory Compliance Analyst at Avara, is the ZenQMS Admin for a 100+ person site in Aiken, South Carolina. Faber reports that as a result of implementing ZenQMS, “We have eliminated several manual processes and have moved the majority of our training, issues, and document management into a single system.” Additionally, she states, “Thanks to ZenQMS, my team is now able to quickly and accurately respond to audit inquiries and the error rate is significantly lower than with our prior quality management system.”
Moving away from paper-based and legacy systems and implementing ZenQMS has helped Avara eliminate 100% of their lost document-related issues. This has allowed them to reallocate resources by bringing on a document control specialist and removing one full-time employee. Avara has also gained the ability to pull accurate lists of SOPs and related documents during audits, helping them to avoid costly slowdowns.