Ancillare is the first and only Life Sciences company dedicated to Clinical Trial Ancillary Supply Chain (CTASCTM) management for pharmaceutical, biotechnology, and contract and medical research organizations in Phase I-IV clinical trials. Their approach consolidates as many supply chain functions as possible throughout the duration of a trial. This mitigates delays and helps avoid non-compliance issues while ensuring efficient delivery of ancillary supplies and equipment to accelerate the approval of life-saving therapies to patients.
Ancillare arms sponsors of global clinical trials with customized, end-to-end supply plans, which enables developers of new therapies to optimize their supply chains using streamlined processes, extensive global buying power, a vast depot network, and proven teams of clinical, procurement, operations, logistics, and regulatory experts. Like many modern Life Sciences organizations, they found themselves at the leading-edge of innovation, but struggling with the inherent problems that come with paper-based quality management systems (QMS).
As a highly regulated company, Ancillare are audited by their customers multiple times a year. With so much at stake, they needed a QMS that would improve their processes and keep them compliant.
Melissa Gillott-Egyed, Director of Quality Assurance at Ancillare, experienced the frustrations of paper firsthand. “I felt like I was always chasing people down to get them to write up events for me. They wouldn’t submit them for weeks at a time, which was totally outside the guidelines of our SOPs. Things weren’t getting completed.”
Additionally, Ancillare was in need of a QMS they could rely on for the foreseeable future.
Transitioning away from Ancillare’s paper-based QMS took some getting used to, but the Ancillare team are seeing the benefits of more efficient processes with ZenQMS. “It was a huge difference. It was a huge transition, but a good one,” said Melissa. “Now we have everything in front of us and we’re making progress.” Their SOP compliance has also improved because they now have greater insight into who is opening and reading documents on time, (and who is not).
For the Ancillare Quality team, having a single source for everything has made their job easier compared to what they had to do on their paper QMS. They can manage their quality processes like Issues and Change Control, and find, compare, and change documents without delay or confusion. “If I update an SOP, I can easily send it out to everyone in the organization and I’ll know if they’ve reviewed it. I can also add test questions, which is very helpful,” said Melissa. “Having everything in one place is the biggest benefit of the system.”
But perhaps the greatest benefit for Ancillare is how ZenQMS helps them from a business continuity standpoint. Like any Life Sciences company, Ancillare has adapted to personnel turnover and continued to move forward. For example, a previous Manager built Ancillare’s entire quality system without help from a consultant. But when they moved to another job opportunity, Ancillare’s processes didn’t grind to a halt. With ZenQMS verified and implemented, the transition from one Manager to another was seamless.
If you’re looking to upgrade from a paper-based QMS, but are worried about how business continuity will be affected, schedule a live demo of ZenQMS and learn how we can put those fears to rest.