This U.S. based contract research organization (CRO), was founded in the early 1980’s and has been committed to cancer research ever since. Quality is at the core of their business model given that their clients are life sciences companies and subject to regulatory compliance and good manufacturing practices (GMP.) The company is audited multiple times each year by their clients and could be audited by the FDA at any time so it is critical that their Quality Management System is best-in-class.
Selection and Implementation of the Electronic Quality Management System (eQMS)
For this CRO, having a robust and reliable Quality Management System is a mandate by their clients but has also become a competitive advantage for their growing business. Early on, the company was using a manual, paper-based system which the team reported to be challenging to store, access, and retrieve documents and data.
In 2013, the company implemented their first online management system for training compliance and transitioned off of a manual/ paper-based system. While the new system offered significant efficiencies over the manual one, but validation for part 11 requirements meant duplicating records outside of the system to maintain compliance.
Hence, the organization conducted a search for a validated system that was part 11 compliant and selected ZenQMS in 2017. The implementation went smoothly and the quality team successfully rolled the eQMS out to their 150+ employees. The team has had a positive reaction to the ease of use and simplicity in the ZenQMS interface. Since much of the staff travels around the world to execute work-- they have seen first hand the benefits of the SaaS/ Cloud service approach over the restrictive nature of traditional on-premise eQMS solutions.
When the business development team shares with prospective clients that they use an eQMS, they are more likely to win the business. Having ZenQMS, a validated, part 11 compliant system, has been proven to be a competitive advantage for them.
ZenQMS has helped a great deal with the company’s ongoing management of training records and they are able to create reports and dossiers quickly and easily. Their Head of Quality reported that years ago, audit findings indicated that the business was unable to provide reliable training documentation. Now, using ZenQMS, it is much easier to manage operations for day-to-day compliance and they have avoided auditor findings of that nature.