"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-docs™ home page includes webparts for example Aggregated tasks for the user and quick links to frequently used areas”
  • “Documents are Authored in the Working Library. The X-docs™ Ribbon interacts with the Document State to  guide the User through the process enhancing usability”
  • “The property popup is easily accessed through a hover on column. Note the information in the properties of this Effective document which includes eSignature information and Periodic Review dates”
  • “X-docs™ New Document feature offers significant advantages over the standard SharePoint functions enabling multiple templates per Content type and options for cascading and auto completing metadata”
  • “X-docs™ includes configurable lifecycle and workflows. Here the Management Approval of the SOP is being initiated”
  • “Once documents are on workflows X-docs™ includes a comprehensive set of Management tools to enable variations and terminations to be dealt with”
  • “Here a Workflow task is being completed, note the collection of metadata and the re-authentication requirement which constitutes the 21CFR Part 11 compliant eSignature”
  • “Once the Approvals have been completed a document can be Rendered and put into the Published Library where is can be accessed on a read only basis  by the document consumers. The most recent Effective version of the document is found in the Published Library”
  • “The Publishing and Rendition process is able to add a completed Signature Page which acts as the manifestation of the eSignature for 21C CFR Part 11 compliance. The PDF can have overlays and controls to stop copying or printing”
  • “X-docs™ products all contain 21 CFR Part 11 compliant Audit Trail, extending SharePoint’s capabilities to capture relevant events. In order to provide accessibility to the information the Audit Trail feature enables filtering to see specific versions, dates or entry types”
  • “X-docs™ includes a Controlled and Issued printing module. This records controlled prints, manages recalls and enables prints to have overlays and embedded information as well as a unique number”

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.

These include: 

  • 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-train™ is designed to support the management of Training Records in a compliant manner. Staff profiles can be setup and current status us easily accessed through a webpart “
  • “Each member of staff has a Training Record which reflects the current training status. In this screenshot the current training status is explained”
  • “The Training Report in X-train™ also included is information on Qualifications, previous employment and any course attended which are not part of the training plan”
  • “X-train™ also has a Working Library where the training requirements are maintained for the User. The User may view their own profile. Each of the products has its own specific Ribbon to make using the system even more straight forward”
  • “The Profile identifies the Training Skills which the User must complete. On this tab these Skills are listed. Additional Skills specific to the User can also be added to the profile”
  • “X-train™ is based upon a structure of Skills, Packages and Positions. These are maintained in the system.”
  • “One of the key features in X-train™ is the ability to measure training through the use of four different options. Read and Understood, Test without Sign-off, Test with Sign-off and Assessment”
  • “If a Skill requires a Test it can be defined in the Skill form or uploaded from a formatted spreadsheet to speed up the process. Pass marks, randomisation, question weighting and correct answers can all be defined in the Test tab of the Skill form“
  • “X-train™ uses a Package to enable a number of Skills to be linked together for ease of handling etc. Within the Package Dependencies can be defined to ensure that any specific order of completion is achieved”
  • “In X-train™ Positions can be created as templates so that groups of users in the same job can have the same baseline training. Positions can contain Packages and Skills”
  • “X-train™ can be organised with Divisions and Departments. Access to the information is permission based. Here a Manager sees all the staff in their Department”

 

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:

  • “X-forms™ offers a full range of preconfigured QMS processes, as see in the links area of this screenshot. Processes have touch points between them consisting of a number of non-conformance feeder processes, a common issue/risk assessment and the option to start a CAPA with multiple actions and change controls”
  • “X-forms™ Deviations is one of the feeder non-conformance processes. Its home page holds the tasks and monitoring webpart”
  • “Each stage of the process dynamically creates forms to collect necessary data, display previously collected data or enable decisions to be made to route the process onwards. The process diagram is provided to guide the user”
  • “As information is collected through the forms it is rendered into a report which can be used as a summary document that can be shared with any third parties in the process”
  • “As the process moves through its stages in X-forms™, tasks are distributed to the participants. The forms can be accessed via the email and task links simplifying the user experience. From each task the Report being created can be accessed in order to provide access to all available data.”
  • “X-forms™ non-conformance processes all share a Risk/issues Assessment process as shown in this screenshot. This can be used to establish the appropriate route to follow, for example whether a CAPA is required or the process closed out directly”
  • “X-forms™ supports the creation of multiple child or sub-processes through its configuration. For example here a CAPA has already been started from within the Deviation. This enables the context to be maintained when 0065tracting KPI and management reports”
  • “Starting a sub-process is X-forms™ opens the form from that process and creates the link between them. Here a second CAPA is being initiated from within the Deviation”
  • “This screenshot shows the result of having created a second CAPA process from within the deviation. Note how the parent deviation cannot proceed until its child CAPAs have been completed. The sub-processes can be monitored from this form as their stages will update as they proceed”
  • “When X-forms™ processes are completed a copy of the PDF report is placed in a read-only library which can be made accessible to a wider group of users through its permissions”
  • “The completed process is detailed in the PDF report which can also then be shared with third parties such as  manufacturing partners as a record of the outcome”