"Electronic quality management systems should balance the people, process and technology triangle of effective organisations. Built on the general fuctionality of SharePoint, X-docs™can be easily configured to do just that."
X-docs is an EQMS built on SharePoint that can be delivered on Premise or in the Cloud.
X-docs allows organisations to simply and effectively manage everything from documents and templates to quality processes and personnel training. It is the foundation of a fully-functional, fully-integrated, single platform quality management system that allows businesses to measure and show (or not) that quality is continuously improving.
X-docs can be delivered ‘on premise’ or ‘hosted’ in a fully compliant GxP datacentre located in Europe and the US.
X-docs – GxP Compliant Document Management
The preconfigured QMS document module sitting on the X-docs enterprise platform has been configured to provide the functionality to manage GxP controlled documentation and maintain the necessary framework to satisfy regulatory authority audits.
This additional functionality includes:
- Preconfigured sites and content types to cover the ISO Quality document pyramid including Policies, Guides, SOPs, Work Instructions, Forms and Templates
- Fully configured lifecycle, versioning and related workflows
- Workflow management fetaures for ease of use
- Enhanced CFR21 Part 11 compliant Audit Trail
- Automated Periodic Review
- Compliant eSignatures associated with workflows
- Automated effectivity of the published PDF versions of documents
- Document Distribution and Training Records
- Compliant Property Changer function for electronic records
- Document Change Control
- Controlled Printing
- Can fully integrate with X-train and X-forms for full compliance management
View screen shots of X-docs by clicking the image below:
X-train – GxP Compliant Training Management
X-train is a secure web-based compliant training environment with traceable course participation, test recording, certification, training records and roles/competency management. Based on the X-docs enterprise platform, employing its configured document management features for the assembly and control of training materials, X-train brings a number of forms based features to provide confidence in being able to meet the rigorous audit demands for training records in support of employees performing regulated actions.
- Configuration of Skills, Packages & Position sites to reflect the organisation need
- Staff Profile management to provide a central source for employee information
- CV & Job Description document management with workflow and approvals options
- Generated Certificates & Training Reports with access to training history
- Link to X-docs documents to alert when controlled documents change
- Auto task distribution and monitoring & retesting
- Options for competence evaluation include Read & Understood, Multi-Choice tests & Skill or Management based Assessments
- Options to record External course, previous employment and qualifications
- CFR 21 Part 11 and EU Annex 11 compliant environment
View screen shots of X-train by clicking the image below:
X-forms – GxP Compliant QMS Process Management
The X-forms configurable process engine allows standard QMS processes to be implemented quickly and easily. Designed to enable the management of complex issues through the use of a multi-threaded framework, X-forms simplifies the job of monitoring and reporting on progress. Designed to meet the requirements of QMS processes such as CAPA, Change Control, Deviations and Audits, X-forms can be configured to route forms around groups and individuals to collect the appropriate input, whether that be impact assessments or root cause analyses, data collection to facilitate reporting and signal detection, or the approvals and authorisations to close out issues.
The main features are:
- Configurable forms processes
- Multi-thread issue support – capability to run multiple child processes
- Process map displayed on open forms
- Continuously updated PDF of the issue as it progresses
- Issue progress/status reporting
- Automated Routing for form completion
- Links to X-docs documents & X-train training modules
View screen shots of X-forms by clicking the image below: