Validation

Blue Mountain's validation assistance service helps FDA-regulated companies get through the validation process quickly and meet compliance requirements. With validation assistance, a company can eliminate the time required to develop internal test scripts, free personnel to validate other essential systems, and implement Blue Mountain Regulatory Asset Manager or Calibration Manager quickly.

Blue Mountain's support specialists are able to perform a variety of validation functions, including:

Installation qualification (IQ) and operational qualification (OQ): Make sure that the installation is completed according to written and pre-approved specifications and document the system's actual operational functioning versus specification.

Performance qualification (PQ) script generation and execution: We work with you to develop the scripts or testing procedures to document that the system performs as required in actual working environments and conditions.

User Requirement Specification (URS) Generation: If you haven't developed one already, we can help you right this document that describes the required functionality from the system. It should establish what the product needs to do.

Gap analysis between URS and Functional Requirement (FR): Examination of the gap between what you need (URS) and what the current software can provide (the Functional Requirement). We help you determine how to use the software to satisfy your needs in the most efficient manner.

Server Qualification: The server components are qualified versus validation protocols to document that the server too is in full compliance.

The support specialists work under the supervision of your validation and/or IT departments to ensure best practices are being followed, as well as fulfilling internal requirements. From the initial overview meeting to the post-validation review meeting, the well-defined, documented process helps to ensure an organized validation.