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Digital Commissioning and Qualification

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

Benefits this Solution Provides

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Generate Validation Plans Automatically

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

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Ensure Timely Planning and Documentation

Stay on task with systematic scheduling and task notifications.

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Manage Critical Documents

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

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Leverage the Power of Automated Test Scripts

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

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Quality Design = Quality Process

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  • 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. 

Satisfy Regulators

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  • 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. 
  • Go beyond ALCOA+ and achieve ALCOA++ for high data integrity. 
  • Ensure perpetual inspection readiness and instill regulator confidence. 

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Embrace Efficiency

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  • Leverage configurable workflows for faster reviews and approvals. 
  • Apply a Gannt 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.

What Can You Expect From Implementing Our Solution?

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.

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