X-docs™ for the Quality and Manufacturing areas

With functionality specifically designed to support Good Practice (GxP) based regulations, X-docs™ is ideally suited to solving all your compliance problems. Deploying modules to manage your controlling QMS (Quality Management System) documents with X-docs™, your compliance related training management with X-train™ and your QMS related processes such as Change Control, CAPA and Audit with X-forms™ provides complete coverage across your regulated environments.

• GxP Compliant Training Management – X-train™
  
  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 it’s 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 X-train™ Screenshots

  
  
  
  
  
  
  
  
  
  
  
• GxP Compliant QMS Process Management – X-forms™
  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 round 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
  • Issue progress/status reporting
  • Automated Routing for form completion
  • Links to X-docs™ documents & X-train™ training modules