Digital Commissioning and Qualification
Ensure the facilities, equipment, and systems used throughout manufacturing fit their intended purpose.
Benefits this Solution Provides
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 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.
- 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.
- 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?
|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.|
See how ValGenesis can support your digital transformation.