Reduce total time to implement and validate a new system

When using internal or inexperienced resources, implementation and validation of new asset management systems can be a long and painful process. It can disturb your ongoing operations and delay the final implementation of the system with no assurances that the validation will be performed to regulatory requirements. For this reason, and to reduce the risk of compliance failures or audit issues (including the dreaded 483), many of our customers have turned to us for tools and assistance during validation.

Validation of a GxP software database is generally comprised of three steps - defining system requirements (URS - User Requirement Statements) matched to the software's functional requirement (FR), qualifying the software vendor, and performing the IQ, OQ, and PQ of the software. Blue Mountain Quality Resources has the experience and resources to help organizations easily and efficiently satisfy each of these steps when implementing Blue Mountain Regulatory Asset Manager.

Many customers take advantage of our Validation Services to manage the complete validation. By outsourcing this activity to someone with substantial experience, companies can drastically reduce the total validation time. Companies validating on their own can experience IQ and OQ completion times of months, sometimes much longer if any unanticipated difficulties arise.

For new facilities or when under pressure to comply with regulatory “recommendations”, it is often necessary to get a new calibration, maintenance, or validation department up and running on a tight schedule. Sometimes short timeframes are further dictated by a desire to harvest the return on investment from more sophisticated software package sooner.

Blue Mountain Quality Resources has the experience and resources to get you up, validated, and running quickly, enjoying the maximum benefits of the new system. The experience of our technicians means that the implementation is done efficiently. And the depth of our resources means that certain steps in the implementation and validation process can be performed in parallel, further compressing the time required to complete implementation.

We can manage your complete implementation, right through the validation, or help you overcome specific bottlenecks in your implementation. Our implementation solutions give you the flexibility and the resources to put you on the fast track.