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, firstname.lastname@example.org or take a look over our website www.gxpi.com for more information on how we can help.
Unit 13 Poplars Court
Tel: +44 115 924 8475
Fax: +44 115 924 8472