From implementation to operation, CRO Biorasi enjoys seamless Quality processes with ZenQMS

The Glacial Pace of Paper

“We came from a manual QMS where everything was tracked on paper, and it just made life difficult and challenging.”

Those are the words of Christopher Culver, Quality Assurance Manager at Biorasi. If you’ve ever worked in Quality, you might be saying to yourself, “Hey, that sounds familiar!” Quality teams at regulated companies are used to doing more with less, and that includes keeping quality in a state of control with tools that are slow and complicated. Moving to a validated electronic quality management system (eQMS) is a smart move for modern life sciences organizations looking to keep pace and stay competitive.

“We needed to make the switch to an eQMS because we were growing internationally,” said Christopher. “We needed a complete eQMS that could handle the volume of documents we were releasing for training and signatures. Additionally, we had to make sure it was compliant with 21 CFR Part 11 and Annex 11 regulations.”

For Christopher and his team at Biorasi, the significant delays they experienced using their manual QMS and cumbersome learning management system (LMS) to try and keep documents up to date were frustrating. For their controlled documents (SOPs, forms, work instructions, etc.), each one had to be sent via Docusign for edits and comments, manually uploaded into their LMS, cross-referenced with their training matrix, and finally distributed to the right employee for training. 

Keep in mind, Biorasi repeated this process for every controlled document. For every employee. The status quo simply wasn’t feasible for a rapidly-growing CRO looking to disrupt the industry and raise the level of service for sponsors.

That’s why Biorasi made the decision to implement ZenQMS.

“Once we got ZenQMS, the revision process was much easier, as was the sign-off process,” said Christopher. “We’re now able to configure workflows so things are done in one stage. Controlled documents go from approval, to signature, to being released for training, and it’s a click of a button. We’re not waiting for 2-3 hours trying to get the right people the right training.”

With intuitive dashboards and the flexibility to make changes in real time, Biorasi has been able to take advantage of the benefits found in an easy-to-use eQMS and move beyond the inefficiencies of paper and manual systems.

“We tried other systems, but they didn’t match how we work,” said Christopher. “They had workarounds, but we weren’t looking for workarounds. We wanted a system that could do what we wanted it to do.”

Implementation that moves at your speed

Of course, none of the benefits of an eQMS matter if it can’t be implemented in the first place. It’s not uncommon for some life sciences companies to wait months or even years before completing their eQMS implementation process. That’s why Christopher appreciated having a dedicated ZenQMS Project Manager to handle the implementation, walk him and his team through the process, and answer questions in a timely manner.

“Joe was our PM and led the implementation. He’s one of my favorite people to work with. My whole experience with ZenQMS has been outstanding. From the contact points in Sales and CS, to the actual implementation, it’s been wonderful.” 

At ZenQMS, a 90-day implementation is standard. The thinking is, the faster your controlled documents can be migrated away from paper files and into a secure, compliant, cloud-based environment, the better. But it’s not just about security, it’s about business. An eQMS is a substantial investment, and facilitating a speedy implementation means companies can begin realizing the ROI that an eQMS is designed to deliver, sooner rather than later. 

“It was no small task, as we were migrating thousands of training records and hundreds of controlled documents like SOPs, forms, templates, and work instructions,” said Christopher. “All of our project-specific documents for training were migrated into the system as well. And Joe was there every step of the way.”

If you’re ready to move away from paper solutions and are looking for an efficient, intuitive system that can help you get started right away, talk to us.