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.
