Norsk Medisinsk Syklotronsenter

Electronic quality management systems should be usable, reflect current regulatory processes and be a stable technology. Formpipe’s X-Docs solution has been built and maintained to those requirements. X-Docs delivers efficiency that can be measured in working time saved and the intangible benefits of allowing the Quality Professional to focus on business improvements rather than administrative tasks.

NMS initially engaged Formpipe through the issue of their RFP and URS in January 2017. Both RFP and URS were a perfect match for X-Docs, with only a handful of items not being met by the Out of the Box (OOB) product. This was then followed with an on-site demo of X-Docs to show how the core functionality met the URS requirements in March 2017.

The implementation of X-Docs took three months, from the point of change control to implementing X-Docs until the system was validated and released for use. Formpipe then guided NMS through the migration process using tools to transfer documents from the current paper-based system to X-Docs and set up the associated Staff electronic training programs. The implementation gave NMS a pre-configured, easy-to-deploy, EQMS that met all the specified needs and could be tailored as and when the need arose.

The contract itself was agreed based on NMS taking the Core OOB product and benefitting from industry best practices this brought to their business operations in addition to standard EQMS functionality.

Keen to implement a more robust way of managing quality assurance and demonstrating their compliant status, NMS researched the market to find a new solution.

They required a system that would not only be effective but facilitate a quick implementation too. A system that would offer the best of both worlds: a pre-configured, easy-to-deploy, EQMS that could be tailored as and when the need arose. The introduction of X-Docs gave NMS a system that was designed to be compliant with Eudralex Volume 4 (GMP) and easy to use.

Formpipe’s X-Docs EQMS is an intuitive solution that reflects current regulatory procedures for the FDA, MHRA and EU markets. Delivered on a stable SharePoint platform it offers pre-built modules and workflows that can be adopted Out of the Box or configured to meet individual needs the result being the easiest and quickest EQMS to deploy within a regulated environment.

NMS selected the pre-configured, SharePoint-based, enterprise EQMS X-Docs by Formpipe utilising the Docs, Train and Forms modules. The latter consisted of pre-configured processes to manage Deviations, Change Controls and CAPAs. The EQMS met all of the company’s specified needs.

The X-Docs solution is scalable and has a full and filterable audit trail, cross-modular functionality and a proven migration path for documents and training programs. X-Docs also includes electronic signature approval workflows that are compliant with relevant regulations such as FDA CFR 21 Part 11.

X-Docs is used by all the staff at the NMS site. All employees are trained in reading documents and signing for them in X-Train. 90% of NMS’s employees are now trained in raising deviations, change controls and CAPAs within X-Forms, as well as writing, updating and sending documents for approval in X-Docs (QMS contribute users).

By changing to an electronic system, NMS’ system became efficient and compliant with GMP.