Blue Mountain RAM Cloud Best Practices

Commercial-off-the-shelf (COTS) Software For GMP Asset Management

With the Blue Mountain RAM Cloud Best Practices, you can achieve GMP compliance and implement quickly while leveraging industry best practices for GMP asset management.

As a software-as-a-service solution, Blue Mountain RAM Cloud Best Practices eliminates the need for upfront investment in software, licenses and hardware while delivering the industry standard Blue Mountain Regulatory Asset Manager® (Blue Mountain RAM) in a highly available cloud environment.

The Blue Mountain RAM Cloud Best Practices works well for firms who want to leverage industry Best Practices to jump-start their operations or for getting into compliance after an audit. With the Best Practices solution, you won’t have to compromise functionality. Our team of industry experts designed this template to include a full set of features and functionality that includes:

  • Complete control of an asset’s life cycle from induction to retirement
  • Enforcement of SOPs and electronic signatures with GMP business rules
  • Management of all work – calibration, corrective and preventive maintenance and validation
  • Paperless work flow and data capture for maintenance and calibration events
  • Management of measurement data and work plans
  • Management and notification of calibration and maintenance incidences and/or failures
  • Full reporting, including work and asset analysis, querying and audit trails for turning data into actionable knowledge

 

What’s Included

  • Online access to the industry standard Blue Mountain RAM (version R3) – including the full functionality of the Blue Mountain RAM platform
  • Streamlined configuration that allows companies to use software in compliance with the FDA’s GMPs
  • Cloud-based infrastructure provided by Microsoft Azure
  • Acclaimed, in-house technical support
  • Ongoing infrastructure and Blue Mountain RAM maintenance
  • Blue Mountain RAM R3 service releases, hot fixes and patches
  • Single tenancy architecture – ultimately meaning that your data is separate from other customers’ data
  • Qualified platform
  • Pre-executed validation

 

Validation Package

Since it’s a tightly, pre-configured software implementation, a complete validation package is available and ready to go, speeding the validation process.

  • Pre-executed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Customer-specific IQ
  • Ongoing validation of future updates
  • Standard Operating Procedures for application use provided
  • Supporting validation documentation provided (User Requirements Specification, Software Requirements Specification and Traceability Matrix)

 

 

A few of our Customers

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