Neuren Pharmaceuticals Implements Egnyte as eQMS in Record Time

Neuren Pharmaceuticals was facing the daunting task of implementing a new electronic Quality Management System (eQMS) while simultaneously developing an entirely new set of quality documentation to replace their legacy QMS. With prior eQMS implementations at other companies often extending well beyond promised timelines, Neuren needed a solution that could deliver on schedule without compromising compliance or usability.

By selecting Egnyte's life sciences solution, Neuren achieved a complete eQMS implementation in just 12 weeks. The intuitive, SharePoint-like interface led to rapid adoption, while the cost-effective validation package significantly reduced the resource burden typically associated with system validation. Today, Neuren is expanding its use of the platform beyond document management to create a comprehensive quality ecosystem that can scale with the company's growth.

Challenge: Implement a compliant eQMS quickly without breaking the budget

Neuren Pharmaceuticals faced the challenge many biotech companies encounter: implementing a validated eQMS that could meet stringent regulatory requirements while being cost-effective and user-friendly.

"In the last decade to 15 years, I've implemented probably over 20 quality management systems," notes Sharon Reinhard, a pharmaceutical executive with 27 years of experience across clinical development, operations, and quality assurance. "We all have a little bit of PTSD left over from prior experiences."

With plans to launch an entirely new quality management system, including SOPs, policies, forms, and templates, Neuren needed a solution that could support this complex transition. Previous implementations at other companies had often extended well beyond promised timelines, sometimes ballooning from 12 weeks to six months or more.

Solution: Egnyte's intuitive eQMS with flexible domains for different workflow needs

After evaluating multiple eQMS vendors, Neuren selected Egnyte's life sciences solution. Key factors in their decision included cost-effectiveness relative to comprehensive features, adherence to 21 CFR Part 11 compliance requirements, straightforward implementation timeline, intuitive interface familiar to users, and flexible multi-domain structure for different workflow needs.

"We had demos from four or five of the big name providers in this space," Reinhard explains. "Seeing the system firsthand, how it works, and if it seems simplistic is important. The easier something is, the easier the uptake is by your organization." 

Neuren implemented three distinct Egnyte domains: 

1. A test environment for experimentation and validation
2. A validated GxP environment for controlled document
3. A non-GxP workspace for drafting and day-to-day collaboration

Benefits: 12-week implementation with high user adoption and cost-effective validation

Despite launching an entirely new quality management system alongside the Egnyte implementation, Neuren achieved go-live in just 12 weeks—a timeline often promised but rarely delivered in the industry.

"This by far was the easiest experience that I've had," says Reinhard. "Most companies promise you a 12-week implementation with a Gantt chart... and then very quickly, you start to realize that timeline isn't going to be met. But in this case, we really did go live in 12 weeks."

Egnyte provided a comprehensive, cost-effective validation package that significantly reduced the time and resources typically required for system validation.

"Egnyte already has what we can call sort of an off-the-shelf set of solutions, scripts, things that are already pretty progressed," notes Reinhard. "That was what kept the 12-week launch more realistic than if you are truly starting from scratch."

The system's intuitive interface led to rapid adoption across the organization. The familiar folder structure and permissions model reduced the learning curve for end users.

"When people are familiar with something, you tend to get faster buy-in and adoption rather than push back and resistance," explains Reinhard. After launch, Neuren achieved nearly 100% training compliance within a six-week training period.

Employees particularly appreciate the secure file-sharing capabilities, which enable them to exchange large data files with external partners without risking exposure of sensitive information.

"We all have to get massive data files and document files from outside parties," Reinhard notes. "The fact that we can send them a link and bring it straight into the system is just not a feature you can use in a lot of other systems where it's secure."

The integrated learning management system streamlined the training process for new SOPs and policies.

"What's nice is you can set the amount of time people are going to have to train. It doesn't force you into something. I like the flexibility of making something effective immediately if I need to start using it right away, or I can set a training period of two, four, six weeks."

Looking Ahead

As Neuren continues to grow, they value Egnyte's scalable licensing model that can accommodate rapid expansion—a common scenario in the biotech industry where companies often grow from 5-10 employees to 30-50 virtually overnight following promising clinical data.

The company is also exploring additional uses for the platform beyond standard document management, including processing deviations, CAPAs, and change controls, leveraging Egnyte's flexibility to create a more comprehensive quality management ecosystem.

"Overall, Egnyte is a straightforward, cost-effective, easy-to-adopt system," concludes Reinhard. "If your needs are to have a one-stop simple solution, something that's cost-effective, that meets the health authorities’ expectations for a 21 CFR part 11 compliant system, and that your management isn't going to have a heart attack when they see the budget, Egnyte is definitely a good option to pursue."