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)

Differentiators

  • 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.

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    ADDRESS

    63739 street lorem ipsum City, Country

    PHONE

    +12 (0) 345 678 9

    EMAIL

    info@company.com

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