R&D and Clinical

The X-docs™ platform layer has been configured to manage R&D and Clinical documentation with storage structures and functionality specifically tailored to meet the needs of these business functions.

Standard Features include:

• Repository and document inventory designs based on the industry standard Reference Models which provide a good starting point for clients to work with and adapt where necessary
• Automated workflow and fully configurable lifecycle engine
• Enhanced audit trail ensuring compliance with Life Sciences regulatory frameworks
• Use of Working Published and Archive libraries to simplify system usage
• Digital and Electronic signatures available for workflow and document sign-off

• Clinical Trials Module
  eTMF module is designed to specifically recognises the different needs of Record and Authored document management. The system includes optional integration with Invu scanning and indexing software to facilitate the rapid upload and indexing of Trial records whether in paper or PDF format. GXPi is developing a number of additional modules to support the core platform including

  • an inventory module to enable the definition of expected incoming records and enable reconciliation and reporting as the trial progresses
  • a record export module to support the creation of Investigator record sets and uploads to other document management systems
  • flexible viewer to support audits and trail management requirements
• R&D documents Module
  Submission related information can be stored in a configured X-docs™ system and linked to a SharePoint compatible Submission publishing system. Using the Hierarchy Builder tools storage structures can be rapidly created and deployed. Using the project Builder functionality this hierarchy builder can be embedded to enable local business administrators to create new structures for new submissions, products or presentations. The X-docs™ New function allows complex metadata relationships to be supported and users assisted in the accurate and rapid indexing of content.
  GxP Compliant Training Management – X-train™
  In the Clinical, Quality and Non-Clinical areas staff are often involved in undertaking regulated actions controlled under the GxP Good Practice regulations. Evidence of the competence is necessary to support audits in these areas. 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™ functions 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

  
  
  
  
  
  
  
  
  
  
  
• R&D/Clinical Audit Process Management – X-forms™
  In the R&D and Clinical areas audits by regulators , partners, sponsors and other groups leads to a requirement to manage the findings and commitments to ensure the maintenance of compliance. The X-forms™ configurable process engine allows standard Audit and other 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. 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