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Digital Commissioning and Qualification

Ensure the facilities, equipment, and systems used throughout manufacturing fit their intended purpose.

Benefits of Digitizing Commissioning and Qualification

Generate Validation Plans Automatically

Generate Validation Plans Automatically

Auto-generate the validation plan and summary with precise, clear metrics.

Ensure Timely Planning and Documentation

Ensure Timely Planning and Documentation

Stay on task with systematic scheduling and task notifications.

Manage All Critical Documents

Manage All Critical Documents

Manage layout drawings, P&IDs, schematics, and software logic/algorithms in one location.

Leverage the Power of Automated Test Scripts

Leverage the Power of Automated Test Scripts

Bring efficiency and speed to document authoring using a decision-tree-based process.

Quality Design = Quality Process

  • Create and perform system- or functional-level risk assessments or enforce risk-based process conditions.
  • Manage deviations/exceptions with predefined workflow options to reduce delays.
  • Manage system- or functional-level changes through a change control module well-suited for the C & Q environment.
  • Enforce standardization using an automated, predefined assessment framework.
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Satisfy Regulators

  • Enhance compliance and reduce data integrity risks with electronic signatures and other security features that meet 21 CFR Part 11 requirements.
  • Enable real-time capture of test results and objective evidence with time-stamped audit trails.
  • Achieve ALCOA+ adherence for high data integrity.
  • Ensure perpetual inspection readiness and instill regulator confidence.
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Embrace Efficiency

  • Leverage configurable workflows for faster reviews and approvals.
  • Apply a Gantt chart approach to manage commissioning projects, timelines, and bottlenecks.
  • Electronically execute commissioning documents (e.g., FAT/SAT/UAT), creating the record in real time.
  • Generate a C & Q genealogy that enables reusable content and historical test scripts for all lifecycle deliverables.
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The Value of Digitizing Commissioning and Qualification

Before After
Manual C & Q processes are a drain on company resources and staff time. Automation frees up staff to focus on revenue-generating activities.
Employees, clients, and regulators have poor visibility into processes and the status of documents. Real-time visibility provides stakeholders with real-time insights.
Manual protocol execution, storage, retention, and retrieval methods can lead to data loss and rework. All steps and associated data elements are recorded with immutable time stamps and are accessible at any time.
Scheduling burdens the business, quality, testing, and technical teams. Automated scheduling, task notification, and nudging features help teams stay on task.

Explore More About Digitizing C&Q Processes

Case Study
Transcat

Transcat transformed equipment qualification with ValGenesis VLMS, cutting project turnaround by four days, saving 1,500 documentation hours, and enhancing compliance, accuracy, and employee satisfaction through digital validation.

Read the Case Study
Webinar
Best Practices in Commissioning and Qualification

Watch the Webinar

Talk to us to see how ValGenesis can support your digital transformation.