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

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

Ensure Timely Planning and Documentation

Stay on task with systematic scheduling and task notifications.

Manage All Critical Documents

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

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.

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.

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.

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.

Before

Manual C & Q processes are a drain on company resources and staff time.

After

Automation frees up staff to focus on revenue-generating activities.

Before

Employees, clients, and regulators have poor visibility into processes and the status of documents.

After

Real-time visibility provides stakeholders with real-time insights.

Before

Manual protocol execution, storage, retention, and retrieval methods can lead to data loss and rework.

After

All steps and associated data elements are recorded with immutable time stamps and are accessible at any time.

Before

Scheduling burdens the business, quality, testing, and technical teams.

After

Automated scheduling, task notification, and nudging features help teams stay on task.

Explore More About Digitizing C&Q Processes

Blog Post

Driving Success with Digital C&Q and Pharma 4.0

Learn about the benefits and impact of transitioning to digital C&Q solutions for enhanced efficiency, compliance, and innovation in a Pharma 4.0 world.

Read the Blog Post

Case Study