x-docs™ allows Quotient to manage their controlled documents on a Microsoft SharePoint platform. It has been configured to their specific controlled document needs and is now being rolled out to over 400 users.
Quotient is a leading provider of early stage and specialist drug development services to pharmaceutical, biotechnology and medical device clients worldwide. Their services are regulated under GCP, GLP and GMP regulations by the MHRA.
They acquired x-docs™ to enable secure sharing of controlled documents in a secure environment across multiple locations, but they also wanted a Validated product that conformed to the FDA‟s 21CFR Part 11 requirements on Electronic Records and Electronic Signatures. This meant compliant audit history, security access, and operational features such as document specific auto-numbering, configured document lifecycle and integrated change request processes.
Standard Operating Procedures (SOPs) are essential documents in Life Sciences businesses and are used to ensure that all quality processes and procedures are carried out in a consistent and compliant manner. SOPs need to be securely stored and tracked throughout their entire life-cycle, including when they are superseded and withdrawn in order to comply with Part 11 electronic records management. This continues into the support for the storage of these „archived versions‟. They decided to use MS SharePoint as their platform as their existing systems did not support the group-wide services they needed. GxPi has developed an SOP module on x-docs™ to streamline and standardise the creation, review, approval, publishing and distribution of SOPs in a fully Electronic Document Management System (EDMS).
x-docs™ ensures compliance with FDA 21 CFR part 11 guidelines by storing the full audit history for each document, allowing electronic signatures to be stored with the document during approval stage. There is also a centralised PDF rendering tool, which saves the user time by allowing the creation of high-quality, FDA-compliant PDFs as part of the publishing process. Other additional functions suited for the needs of the Life Sciences industry include:
x-docs™ was a great help when, earlier in 2010, Quotient acquired a new business with many existing documents, and they were able to migrate the existing documents straight on to the new system making for a hassle free changeover. Quotient were using the hosted version of the x-docs™ product at the time which means that their documents are held on GxPi’s secure servers in their validated data centre. The system was taken in house on Quotient’s servers in November.
The Quality Manager at Quotient comments that "We chose GxPi and x-docs™ because the team seemed to understand a lot of our problems with controlled documents, particularly where we had documents that were going to be shared across multiple sites and access would be based on permissions. We really liked the simple user interface and the integration with our existing working tools. We were able to talk to some of their other customers who had employed x-docs™, and we looked hard at their processes and systems and were very satisfied by what we found".
The Group ICT Manager commented "We had already established that SharePoint was going to be our platform and, after talking with GxPi, we realised that they not only had the skills to deliver the compliance aspects of the document management system, but as Microsoft Gold Partners, they had the technical skills to configure our build. We knew we wanted some new code functions and features building, and also some specialised webparts and they were able to quickly understand what we wanted and why.
They had developed some useful tools to deploy, build, assign permissions and test quite a complicated site hierarchy. We were also pleased to see that they had other solutions on SharePoint for compliant training management and Digital Signatures that we could integrate at a later stage."
Keith Williams, CEO, GxPi comments: "We are really pleased that this project has been such a success. When we started the process, we spent time educating the Quotient team around what was possible with SharePoint and x-docs™, establishing and capturing their baseline requirements, and setting up a test area for them to work in.
We then built a detailed design specification and configuration specification with them and helped bring one of their sites on-line sooner than expected to migrate their documents following an acquisition. After the build and testing we trained the key User group and administrators and delivered a User manual specific for their system. Most of the time both project teams worked in a very constructive and collaborative way, and this has made it a pleasurable experience right the way through the process."