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