8
min read
Growing Together: The Story of Third Pole Therapeutics - Making Quality Management Better
A complete shift from a paper-based eQMS to a digital compliance platform.
Cardiopulmonary Therapies
ALM & QMS
Boston, USA
Company Overview:
Third Pole, founded on Professor Warren Zapol's groundbreaking research, develops an investigational device that produces pure Nitric Oxide (NO) for inhalation. Inspired by a lightning-struck moment, our device relaxes lung blood vessels without compromising systemic blood pressure. With NO's antimicrobial properties, including effectiveness against drug-resistant strains, we're dedicated to advancing respiratory care in honor of our founder, Warren M. Zapol, MD.
"The decision to consolidate processes into one system, avoiding the learning curve of another system, was optimal for us. It was cost-effective for expanding our training management capabilities using the existing EQMS solution," the team noted.
The Transformation Challenge: Transitioning to Electronic Quality Management System (EQMS) at Third Pole
When Third Pole realized their paper-based quality management system couldn't keep up with the company's expansion, the Quality team knew it was time for a change. To support ongoing growth and product development, they decided to adopt an electronic quality management system (EQMS).
As an organization that innovates in medical devices and services, Third Pole previously relied on paper to manage its quality processes and procedures. However, this method was no longer sufficient for the company's evolving needs.
eQMS selection process
The team explored various EQMS providers to find a software solution that could handle their Quality Management System and integrate training management. Orcanos was chosen for its comprehensive EQMS solution, including a Training Management module. This module was seamlessly integrated with the EQMS Document Control module they were already using, eliminating the need for additional third-party training software.
Finding the Right EQMS Fit: Simplifying Training and Documentation with Cloud-Based EQMS
Anthony Raymond and the quality team discovered Orcanos ALM/QMS, a preconfigured cloud-based EQMS designed for quick setup for small companies. They opted for the Orcanos "PREMIUM" package, tailored to Third Pole's needs for training and document management solutions.
With Orcanos being cloud-based, Third Pole didn't need dedicated servers or IT staff on-site. The system enabled efficient management of CAPA documentation and streamlined collaboration. It also met Third Pole's educational needs for training.
By moving to Orcanos, Third Pole reduced the operational costs associated with their previous paper-based processes. They have since implemented additional Orcanos modules, like Change Control, without incurring extra costs for third-party software.
Time Savings: 90 Seconds vs. 90 Minutes
With Orcanos, Third Pole imported about 5,000 documents with ease, thanks to the built-in import tools. The most significant improvement was in training program management. What once took over an hour now takes minutes. The process for training new hires has been significantly simplified, with automated reminders and easy training status checks.
"This efficiency is crucial for us, a growing company with nearly 100 employees where staff often take on multiple roles. The saved time allows our Document Control Specialist to focus on other QA tasks," they shared.
Achieving Audit Excellence by Enhancing Training Programs
Third Pole's adoption of Orcanos eQMS led to a successful recertification audit for ISO 13485. The auditors were impressed by the system's efficiency in document retrieval for quality and training documentation.
Timely and Economical Implementation
The cloud-based, preconfigured nature of Orcanos EQMS allowed for quick implementation. Third Pole is planning to expand its use of Orcanos modules, providing a cost-effective alternative to internal development.
Additional Benefits of Orcanos eQMS
Orcanos has become a trusted solution for Third Pole, offering:
- Affordable document control
- Compliance made easy with preconfigured templates
- Increased productivity with fewer people
- Scalable solutions for company growth
- Faster market entry for products
- Time and resource savings
- Access to on-demand education and training
- Easy regulatory document review and organization
- Seamless upgrades and validation
- Elimination of the need for dedicated IT staff
The Result
Faced with aggressive market timelines and stringent FDA regulations, Third Pole, a small company of about 100 employees, needed an efficient way to manage its ISO 13485-certified QMS. Orcanos eQMS provided a solution that enhanced efficiency and productivity, proving essential for the company's success.
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