Continuous Validation of QMS Software

Why Continuously Validate Your QMS Software?

Validation is Required by FDA 21 CFR Parts 11 & 820

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

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

xLM Provides Continuous Validation for Your Modified Intellect Applications

To simplify and automate the validation process, Intellect has partnered with xLM to provide a simple solution for continuous validation.

xLM helps Intellect customers:

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

How Does Continuous Validation Work?

xLM simplifies and automates the validation process by providing:

• 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)

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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Continuous Validation