Achieve control over the validated state

Controlling the validated state of assets and processes can be a time consuming endeavor at some organizations, and hit or miss at others. Calibration, maintenance and quality personnel each play a role in this process and the best results are achieved when they are able to share information and work together seamlessly.

For most equipment and instruments, procedures require regular preventive maintenance and calibrations to be performed and documented to keep those assets in the validated state. Sometimes discovery during the maintenance or calibration event will reveal something that jeopardizes the validation and requires activity by another group to allow the asset to remain in active use. For example, a maintenance event may require recalibration or even revalidation of an instrument or a piece of equipment. When changes occur evaluations must be made to determine the impact on the validated state, impacting the asset’s availability for regular activity.

Blue Mountain Regulatory Asset Manager allows quality personnel to achieve control over the validated state. With calibration, maintenance and validation personnel all using a single system to manage assets, the software can be configured to send automatic notifications across groups to notify when an activity has been scheduled or completed. With this notification any follow up activity that may be required can be scheduled quickly and efficiently and quality personnel are aware immediately when activity that threatens the validated state has occurred.

Blue Mountain Regulatory Asset Manager also features configurable electronic approval routing to improve work flow and processing of approval on changes. Data entry on the record can be restricted based on the current status of the record and prevented from being used if not an “approved” state. With strict control of records and audit trail on activity throughout the application, all aspects of the validated state are controlled, even down to storing procedures and results from qualification activity.