IT & Software

GxPi - Consulting and Compliant Document Management Solutions

GxPi specialises in simple to use Quality & Lean Compliance solutions for the Life Science industry. Specifically looking after the smaller companies in the sector. Either through x-docs™ (our Microsoft SharePoint based content/document management solution) or high value, high impact consulting services.

Any area where compliance, validation and quality management is required.

  • Hosted or client site modular solutions - Grow as you grow - Five users upwards
  • Save money, resources and time
  • Enable efficient and effective process, with reduced risk

Solutions - x-docs™

Developed to assist smaller Life Science companies deliver functional process based solutions. x-docs™ is our modular 21CFR Part11 Compliant ECM/eDMS to deliver integrated:

  • QMS / SOP process, content and template management
  • Forms based CAPA
  • Change control and deviation management
  • Regulatory content control, including eTMF
  • Reduced risk compliance

x-train™ is our configurable eTraining environment, which supports rich media training course material (provided as part of the package or added/supplemented by the user organisation) and enables understanding to be confirmed via configurable multiple choice tests, all within a compliant, KPI measured environment.

  • CoSign® is the licensed Electronic Signatures solution
  • AdLib is our partner for high quality PDF document rendering and publishing solutions

Services - GxP Consulting

High impact, high value resource and Services specialising in:

  • SharePoint – Implementation, integration, development and support
  • Regulatory compliance help and support to its clients operating within GMP, GLP, GCP and GDP environments
  • Computer system validation and complianceincorporating CFR21 Part 11 and GAMP compliance
  • Project management of ISPE baseline methodologies and good engineering practice (GEP)
  • Strategic consulting – Planning and support and smart integration of technology for clinical trials management
  • Qualified person (QP) support services
  • BioPharma process development and technology transfer
  • Training - GxP coaching and knowledge transfer – eLearning and classroom

Please contact GxPi on +44 115 924 8475, or take a look over our website for more information on how we can help.

GxPi Limited
Unit 13 Poplars Court
Lenton Lane

Tel: +44 115 924 8475
Fax: +44 115 924 8472