21 CFR Part 11 Compliance
Asset Management
Maintenance Management
Calibration Management
Cloud Infrastructure
21 CFR Part 11 Compliance
Compliance requirements can be costly and time consuming – during initial configuration of a software
and on-going usage. Blue Mountain Regulatory Asset Manager® (Blue Mountain RAM) is purpose-built to streamline and simplify asset management, maintenance, and calibration for companies while providing the necessary tools to manage compliance, including customizable workflows with e-signature capability.
Here are a few examples of Blue Mountain RAM’s built-in features:
Security
- Access limited to authorized individuals
- User Authentication
- Access credentials must be unique to each user
Electronic Signatures
- 2 components required for initial signing in a session
- Signature reasons
- Associate e-signature to a specific record
Audit Trails
- Old/New values
- Audit reason
- Date & Time stamp
- Name of person making change
Validated System
- GAMP 4 & GAMP 5 approach