ZenQMS Supports Autumn Harp’s Commitment to “Pharma-Ready” Standards and Continuous Process Improvement

Continuous Process Improvements are a Priority

When Allie Foco joined Autumn Harp as their Quality Systems Manager, she encountered a quality system that, while fundamentally sound, was predominantly paper-based and cumbersome to manage. For example, during a routine document search, she discovered firsthand why tracking was so time-consuming. Document control was performed manually, which meant that updating documents and re-controlling them took a long time and the system didn’t scale well as the company continued to grow. Additionally, the training activities were difficult to track as it too was a manual physical paper-based system and hard to see how the company was doing as a whole.

The shortcomings of a system like this are obvious: compliance with regulatory bodies is more difficult than necessary, and timely data retrieval, especially during high-stress audits, is cumbersome. Having document control and training that relies on physical paper records is much more difficult to Audit.

For someone like Allie, with a Quality background in the highly regulated pharmaceutical industry for sterile injectables, a limited manual quality system wasn't going to cut it. She was set on keeping Autumn Harp ahead of the curve and ready for change. Her goal was to not just meet, but exceed the regulatory requirements for cosmeceuticals across FDA, Health Canada, and EU standards.

“We started looking for a Learning Management System (LMS), but I knew about ZenQMS from before I started at Autumn Harp,” said Allie. “I pitched an eQMS to Leadership as it would allow us to have a robust LMS but would also come with the bonus of being able to capture all of our quality workflows, audits, document control, and be compliant with current 21 CFR Part 11 requirements. And it would stand up in an FDA audit. That’s when I got more buy-in.”

The choice to implement ZenQMS has changed the landscape of quality management at Autumn Harp, turning a previously clunky system into a cohesive, efficient, and compliant framework. But what it really boils down to is this: Autumn Harp now enjoys faster, easier audits because ZenQMS comes complete with what inspectors are looking for.

“Because Autumn Harp is dedicated to continuous improvement, we went with ZenQMS. From my point of view, the most important thing is that ZenQMS is CFR compliant, ISO 9001, and 27001 certified, and maintains these systems with vigorous, robust validation and verification practices. They have been transparent with all updates and even provide all validation work they perform, and UAT scripts if needed for your facility.”

More Streamlined Audits

For a cosmetics and OTC manufacturer like Autumn Harp, hosting frequent, sometimes remote audits from multiple sources is business as usual. That’s why having such an organized, flexible, and validated eQMS is so important. ZenQMS allows Autumn Harp to shine brightly during customer audits, as they can configure workflows to match the specific needs and requirements of their customers, even when they change over time.

In the case of regulatory audits, ZenQMS has proven to be an upgrade over their previous system as far as training compliance and document control is concerned. The intuitive interface means even employees with limited computer access can easily use the system, significantly enhancing the operational visibility.

“Not everyone here has a computer, so Autumn Harp needed something that was simple to use,” said Allie. “It had to be intuitive.”

Now that training records and SOPs are readily available and trackable in a centralized system, instead of being stored across multiple locations, audits move faster, and business can get back to normal that much sooner.

“We’ve got everything an auditor could possibly need right at our fingertips,” said Allie. “Based on how our audits have been going, ZenQMS has proved itself to be an invaluable asset.”

The decision to adopt ZenQMS was driven by Autumn Harp’s commitment to Continuous Improvement regarding Pharma-ready standards. Based on their ability to have more transparency and configurability around training, to keep documents in a state of control, and to meet the highest levels of regulatory scrutiny, it’s safe to say they succeeded.

Experience the future of quality management today. Schedule a demo and see how you can transform your quality systems with ease and efficiency. Don’t just meet compliance standards –  exceed them with ZenQMS.