With the FDA’s current standards, you must track everything you possibly can about Assets. You have to be able to justify the need for an unscheduled calibration, an emergency repair or even the retiring/decommissioning of an asset; yet it can be hard to trace these activities from their origin. Paper processes may not be enough to handle these kinds of tasks and can lead to many inefficiencies in your facility. For example, compiling a request via a paper document can be time consuming; hand writing may be illegible when referenced in the future; and paper requests can be lost throughout the process of submission, requiring everything to be started over. A more efficient method for handling requests is through an Enterprise Asset Management software, such as Blue Mountain RAM. A software solution can allow for digital tracking of requests for work and data changes, as well as electronic signatures to handle review and approval of these requests.
Blue Mountain RAM has the capabilities to handle these processes through the Request record types that are integrated in the software. Blue Mountain RAM allows for rights controlled asset and work management. Requests can be submitted by Request Only Users that utilize license free accounts or by Blue Mountain RAM users who do not have Asset creation or work creation rights (among other things).
A common scenario where requests become useful is when technicians are granted rights in Blue Mountain RAM only for execution of work and not for the creation and allocation of work orders. To alleviate the issue of not being able to create work, Blue Mountain RAM allows for the creation of a Work Request so that supervisors can handle the creation and allocation of work and the software can track the work from its inception via the Work Request. This process will lead to better work management and accountability so that you can build the whole story with evidence to show via an Audit Trail when audits occur.
Each Blue Mountain RAM R3 instance can handle up to seven different Request types. The most common requests are Work Requests, Asset Induction Requests and Change Requests. Other request types include requests for Asset Decommission/Retirement, specific work type requests (Calibration Only/Maintenance Only), User Login and Security Rights Requests and Vendor Qualification Requests.
Request Window Seen By All Blue Mountain RAM Users:
Request Window Seen By Request Only Users in Blue Mountain RAM:
You have the ability to build these requests how you see fit. Furthermore, you have control over the data tracked in the fields across two different tabs on each Request record. Request records also allow for a Workflow to have a review and approval process for any type of request. A review process allows for a seamless transition from paper-based approval signatures to Electronic Signatures in compliance with 21 CFR Part 11. Workflows for any request record can also include email notifications to the Request Originator.
With the benefit of the free and unlimited Request Only User licenses, you can easily integrate the request system throughout your facility. Tracking requests for general facility work or GMP Asset work will allow you to have full control over how work is handled. The ability to have anyone in your company file these kinds of requests allows you to leverage more Blue Mountain RAM functionality, while saving paper and working towards a more efficient facility.