Formpipe Lasernet GmbH THE SQUAIRE 12 Am Flughafen 60549 Frankfurt am Main Email
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Formpipe, inc. 1200 US Highway 22 E Suite 2000 Bridgewater, NJ 08807 Tel : +1 908 200 7937 Email
Drive for continuous improvement
Norsk medisinsk syklotronsenter AS (NMS) was the largest single investment in advanced medical research and diagnostics in Norway. It was financed by GE Healthcare AS, the Research Council of Norway and the Ministry of Education.
NMS produce and develop short-lived radioactive pharmaceutical products (radiopharmaceuticals) for use in PET (Positron Emission Tomography) scans and for quality control. These laboratories must satisfy requirements for pharmaceutical production and radiation protection.
As part of NMS’ drive for continuous improvement, while the existing quality and compliance measures were sufficient, NMS realised there was an opportunity to improve efficiency across business procedures and quality management systems.
By introducing X-docs, NMS improved efficiency, data integrity and GMP compliance
Saves time and money
NMS has already seen a reduction in manual administration, saving both time and money
Expandability and scalability means the new platform can be adapted to meet the changing needs of the organization.
An EQMS to meet specified needs
Electronic quality management systems should be usable, reflect current regulatory processes and be on 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 during 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.
Implementation of the X-docs software 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 form 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 arises.
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.
Standard functionality challenges and evaluating operations
NMS encountered challenges in their existing paper-based system as it was labour intensive to manage and time-consuming to locate data and generate reports.
As the business expanded to multiple locations, it became apparent that using a paper-based system and a “wet ink” approval process would be increasingly difficult for NMS’s Quality Assurance team to manage.
When NMS moved into their new offices, they realised that their QMS system had to be more efficient, with the need to improve and streamline processes. In addition, NMS needed a system that would ensure a high level of data integrity and that would support remote approval via electronic signatures compliant to the relevant regulatory regulations.
With a clear mandate to deliver value, drive efficiency at every opportunity and a dedication to continuously improve processes across the company, NMS decided to assess their current methods of quality assurance and compliance management.
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, electronic quality management system 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 preconfigured 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 to 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.
Benefitting from improved quality assurance and compliance management
With quality assurance and process management transformed, NMS have noted several benefits as a result. Firstly, the firm has reduced manual administration representing a significant cost saving for the business. With X-docs in place, NMS also has full visibility over its entire quality-based workflows. The key performance indicators, automated reporting, sophisticated search functionality, and audit trail insights are providing a level of transparency that surpasses the capabilities of previous methods. For processes like SOPs, NMS can now establish which members of staff are qualified to perform certain tasks, and which ones aren’t in a matter of seconds.
Tina Solvang Tungen, IT and validation manager, NMS, comments, “The new system has improved the GMP compliance and data integrity of our QMS as it comes with audit trails, electronic signatures and automated data analysis tools. It has also made our QMS more efficient.”
“Now several people can work on the same documents at the same time without any loss of data or time because people are working on different or wrong versions of a document. People can sign of documents, forms, etc. at the time they are doing the work without needing to be in the same office. This has been useful since we have two office locations. It has also made it easier to work from home, which have been crucial during the Covid-19 pandemic.”
“The introduction of an electronic document management system has freed up resources in QA because the QMS now is easier to maintain. The introduction of X-docs has made it easier to control that people are trained in the correct procedures, that the current version of a document is available and being used and it is easier to get signatures as people can sign of documents, forms and training electronically. NMS would not have been able to grow as much as we have without introducing an electronic document management system, as it would have been challenging to maintain all the manual overviews. I would estimate that we would have needed an additional full time QA employee to maintain a similar paper-based system, in addition to being a less GMP compliant system.”
Tina concluded: “We are really happy with the support we are getting from Formpipe during regular operations of the system, and that Formpipe listen and includes improvements that we suggest and desire.”