Continuous Validation

Continuous Validation

With our partner xLM

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Validation is required by FDA 21 CFR Parts 11 & 820

Why continuously validate your QMS software?

Regulatory compliance

All pharmaceutical and medical devices, most dietary supplements, and some F&B companies are required to validate their Quality Management Software (QMS) solutions regularly.

Save time

Continuous validation of applications can be extremely time-consuming when performed manually.

About xLM

Through innovative technology, xLM makes the traditionally complex, manual Cloud software validation processes simple, effective, and seamless. xLM also develops, markets, and provides online validation services, including the Automated Validation Manager.This is an online subscription service that provides validation services for life sciences companies through xLM’s online validation services platform.

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xLM helps Intellect customers

Continuous validation for your modified Intellect applications

Continuous validation for your modified Intellect applications
Intellect logo

xLM helps Intellect customers

Continuous validation for your modified Intellect applications

Simple & easy

To simplify and automate the validation process, Intellect partnered with xLM to provide an automated solution for continuous validation.

  • Ensure validation on a continuous basis
  • Reduce compliance and business risk

How does continuous validation work?

  • Continuous validation for Intellect apps
  • Automated testing in a dedicated test instance
  • Deliverables include:
    • Validation Plan (VP)
    • Configuration Qualification (CQ) Protocol
    • User Acceptance Test (UAT) Protocol
    • Trace Matrix
    • Validation Summary Report (VSR)
    • Customers to provide User Requirements Specifications (URS)