GXPI has announced that its X-Docs Server electronic document management solution (EDMS) has been installed by Quotient Bioresearch across four sites in the UK.
X-Docs allows Quotient to manage its controlled documents on a Microsoft Sharepoint platform.
It has been configured to its specific controlled document needs and is now being rolled out to more than 400 users.
Quotient is a provider of early stage and specialist drug development services to pharmaceutical, biotechnology and medical device clients.
It acquired X-Docs to enable secure sharing of controlled documents in a secure environment across multiple locations, but it also wanted a validated product that conformed to FDA 21 CFR 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SOPs need to be securely stored and tracked throughout their entire lifecycle, including when they are superseded and withdrawn, in order to comply with Part 11 electronic records management.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'.
Quotient decided to use MS Sharepoint as its platform as its existing systems did not support the group-wide services it needed.
GXPI has developed an SOP module on X-Docs to streamline and standardise the creation, review, approval, publishing and distribution of SOPs in an 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.
Additional functions suited for the needs of the life-sciences industry include: configurable document lifecycle and workflow-based state transition; approval workflows with user authentication (enables Part 11 compliant e-signature); configurable approval groups; read and understood distribution - groups configurable at point of despatch; PDF-published approved versions for content consumers to access; configurable autonumber function; automated document effectivity function; periodic review functionality; Infopath forms-based document change process; automated sitebuilder and configuration tools to enable the creation and rapid validation of complex storage structures; Infopath forms-based CAPA module.
When Quotient acquired a new business with many existing documents in 2010, X-Docs enabled it to migrate the existing documents straight onto the new system, making for a hassle-free changeover.
Quotient was using the hosted version of the X-Docs product at the time, which meant that its documents were held on GXPI's secure servers in its validated data centre.
The system was taken in-house on Quotient's servers in November.
The quality manager at Quotient said: '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,' the quality manager added.
The group ICT manager at Quotient said: 'We had already established that Sharepoint was going to be our platform and, after talking with GXPI, we realised that it had the skills to deliver the compliance aspects of the document management system and, as Microsoft Gold Partners, it had the technical skills to configure our build.
'We knew we wanted some new code functions and features building, and also some specialised web parts and it was able to quickly understand what we wanted and why.
'It had developed some useful tools to deploy, build, assign permissions and test quite a complicated site hierarchy.
'We were also pleased to see that it had other solutions on Sharepoint for compliant training management and digital signatures that we could integrate at a later stage.'
