Continuous Validation Solution

iLink and xLM are partnering to deliver a GxP validation tool for Microsoft.

What is GxP Validation?

  • Validation is providing “documented” evidence that software performs as per its pre‐established acceptance criteria while operating in its production environment with all its interfaces.
  • The End Customer has the regulatory obligation to ensure any software service that directly or indirectly impacts the drug product and/or patient safety is duly “validated”.
  • This can be an onerous task in the SaaS world considering the complexity of the Platform/Apps and the velocity of changes.

Old Thinking Around Cloud Validation

  • Validation costs are supposed to be high
  • Validation must be time-consuming and resource-intensive
  • “Old style paper‐based” validation is the only validation option even for modern cloud apps.
  • For Life‐sciences firms, validation must be a deterrent to cloud adoption

Value Proposition

  • We can validate any cloud App “continuously”. This enables customers to “GxP enable” their instances shifting focus to using the App to its fullest potential.
  • Our technology platform automates the GxP validation process alleviating compliance risk‐ related concerns – all while considerably reducing spend and increasing speed to market.
  • Our managed service is governed by a cutting‐edge Quality Management System built on ISO 9001:2015, 21 CFR Part 11, Annex 11 and GxPs.

Market Segment Segments & Industries

  • Global Pharmaceutical / Biotech / Med Device Companies
  • SMB Pharma / Biotech / Med Device
  • Contract Manufacturing Organizations (CMO)/ Packaging Organizations (CPOs)
  • Third Part Logistics Companies (3PLs)


  • Know‐How – unmatched cloud validation and FDA GxP knowledge/expertise
  • Innovation Enabled – first of its kind, automated, continuous validation platform for Cloud Apps
  • Built for Purpose – build around requirements of Life‐science companies to enable seamless consumption of periodic updates.

    Etiam magna arcu, ullamcorper ut pulvinar et, ornare sit amet ligula. Aliquam vitae bibendum lorem. Cras id dui lectus. Pellentesque nec felis tristique urna lacinia sollicitudin ac ac ex. Maecenas mattis faucibus condimentum. Curabitur imperdiet felis at est posuere bibendum. Sed quis nulla tellus.


    63739 street lorem ipsum City, Country


    +12 (0) 345 678 9