4
min read
How Blue Mountain Simplified Auditor Preparation with Orcanos’ Custom Reporting
Medical Device
Document Control
Pennsylvania, United States
Blue Mountain, founded in 1989, is a software development company that serves the Life Sciences industry. Its flagship product, Blue Mountain Regulatory Asset Manager (RAM), helps pharmaceutical, biotech, and medical device companies manage calibration, maintenance, and validation systems, ensuring GMP compliance and supporting operational excellence.
“With Orcanos, we were able to generate a custom compliance report that gave us exactly what the auditor needed. What used to be complex and manual is now simple and accessible — Orcanos adapted the system to our needs, not the other way around.”
When Blue Mountain faced the challenge of presenting critical documentation to an auditor, they needed a fast, precise, and compliant solution. Orcanos stepped in to deliver exactly that — tailored to their unique needs.
The Challenge
Blue Mountain needed to present a folder containing more than 40 Document Management System (DMS) records to an auditor.
The auditor required visibility into the condition of each DMS from a training perspective — information that was spread across different places and not easily accessible.
Manually compiling and verifying this data would have been time-consuming and error-prone.
The Orcanos Approach
The Orcanos Professional Services team worked closely with Blue Mountain to design a custom report that met the auditor’s exact expectations.
The process included:
- Defining the report requirements — what it should look like, what information it must contain, and which folder it should pull from.
- Collaborating with the R&D team to develop and implement the report directly in the Orcanos system.
The Outcome
With the new custom compliance report in place:
- Blue Mountain could instantly access all 40 DMS records with their training status in one place.
- Auditor preparation became faster, simpler, and more reliable.
- The compliance process became more transparent and streamlined.
Why It Worked
Blue Mountain highlighted Orcanos’ adaptability as the key to success.
Instead of forcing them into a rigid system, Orcanos adapted the platform to their specific audit and reporting needs — ensuring both compliance and efficiency.
A Happy Customer
The result? A smoother audit process, less manual work, and a satisfied client.
As Blue Mountain’s representative put it, the ability of Orcanos to custom-fit solutions to their needs made all the difference.
💡 Lesson Learned: For organizations serving regulated industries, compliance tools must be flexible enough to match the unique workflows and reporting needs of their customers — without compromising speed or accuracy.
Trusted by
