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GxPi

Consulting and Compliant Document Management Solutions

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GxPi

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, info@gxpi.com or take a look over our website www.gxpi.com for more information on how we can help.

GxPi Limited
Unit 13 Poplars Court
Lenton Lane
Nottingham
NG7 2PW

Tel: +44 115 924 8475
Fax: +44 115 924 8472
info@gxpi.com
www.gxpi.com

BioPharma Process

Providing you with a wealth of experience and knowledge to help get your biopharma products and processes developed, validated, approved and to market.

GxPi is able to provide you with the knowledge and support you need in taking laboratory based concepts all the way through to full-scale pharmaceutical manufacture. This service incorporates initial process studies, where choice of the appropriate strategy will minimise time to market, through to final implementation of full-scale manufacture and process validation. Strategic consulting…

Clinical Technology

Utilising expertise and experience to deliver the best selection, integration and use of e-clinical technology solutions for your business.

Our team has unrivalled experience of working both with sponsors and vendors on a wide variety of technology issues and applications relating to management of clinical trials. This experience covers the spectrum of activities from pre-clinical through to phase IV clinical trials. Our consultants are fully conversant with the regulatory requirements of Good Clinical Practice…

Computer Compliance

Validation and compliance to define, prove and maintain your regulatory requirements.

Our highly experienced consulting team can provide your business with support in the specification, design, ensuring GxP compliance and adherence with all applicable regulations and best practice guides, including 21 CFR Part 11 & Good Automated Manufacturing Practice (GAMP) for the procurement, implementation, testing, validation and maintenance of systems. An essential part of any pharmaceutical,…

Regulatory Compliance and QP Services

Enabling dossier submission and regulatory approval and release of investigative and marketed products world-wide.

GxPi has many years of experience in advising on how to best meet the regulatory requirements of the MHRA, FDA, EMEA, CDA, HTA, WHO and ICH. Our consultants are highly skilled and experienced in identifying, communicating, managing and delivering your Good Manufacturing Practice (GMP), Good Automated Manufacturing Practice (GAMP), Good Clinical Practice (GCP), Good Laboratory…

Validation

Smart, cost-effective and resource efficient validation to demonstrate regulatory compliance.

Whether it is a single, stand-alone equipment item or an entire facility, the GxPi team is able to support you with the planning, management and implementation of validation. With a huge amount of accumulated knowledge and experience, our team of validation project managers, validation engineers and validation scientists is able to help your business complete…

x-docs Solution

For management of SOPs, controlled templates, clinical trial and R&D content management, QMS and templates, forms – CAPA management, change management, deviation management. We also offer compliant training management and certification as well tested integrations with third party application.

x-docs hosted solution x-docs™ hosted offers companies who want to commence compliant document and content management an easy and cost effective starting point. You can get going quickly and your site will grow as your business grows. Out-of-box hosted, 3-15 users. Configured hosted, 15-75 users. Key features include: • Microsoft SharePoint platform with enhanced document…
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