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:

  • 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

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