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Webinar

Accelerate with digital C&Q

Boost production efficiency with digital C&Q! Learn how to streamline commissioning, enhance compliance, and drive faster results in this must-see webinar for validation professionals.

Release Date

November 01, 2023

Webinar length

60 minutes

Watch on demand

About this webinar

Life sciences teams face relentless pressure to shorten validation cycles while maintaining compliance and audit readiness. This on-demand webinar shows how moving from paper or hybrid approaches to fully digital Commissioning and Qualification (C&Q) can transform lifecycle management. Senior Process Engineer Amy Wilhite shares a pragmatic roadmap, real benchmark data, and actionable strategies for scaling digital C&Q across global sites.

88%

reduction in approval workflow durations

60%

reduction in process cycle time

40%

reduction in overall process steps

Topics covered

  • Digital maturity levels: from hybrid and paper-to-glass to fully digital workflows
  • Structuring C&Q documentation in operational execution order
  • Automating document numbering, field population, and requirements traceability
  • Benchmark results from Kneat customer case studies on approval and cycle-time reductions
  • The "global core plus site flexibility" model for multi-site standardization
  • Remote collaboration, real-time analytics, and audit readiness capabilities
  • Adopting digital C&Q without reinventing your validation lifecycle process
  • Unlocking hidden data in validation documents for trend analysis and continuous improvement

Who should watch

Life sciences teams face relentless pressure to shorten validation cycles while maintaining compliance and audit readiness. This on-demand webinar shows how moving from paper or hybrid approaches to fully digital Commissioning and Qualification (C&Q) can transform lifecycle management. Senior Process Engineer Amy Wilhite shares a pragmatic roadmap, real benchmark data, and actionable strategies for scaling digital C&Q across global sites.

Speakers

Senior Process Engineer, Kneat

Amy Wilhite

Amy is a highly experienced validation engineer with a demonstrated history of excellence in the biotechnology industry. She is an expert in laboratory operations, bioprocess manufacturing, and equipment/facility/utility CQV. 

Frequently Asked Questions

Do I need to replace my entire validation process to go digital?

No. A recurring theme in this webinar is that digital adoption does not require rebuilding your lifecycle process from scratch. You can import existing templates so documents look familiar while gaining smart behaviors like auto-populated fields and structured workflows. The platform supports your current process — it simply makes it faster and more compliant.

How much faster are digital C&Q approvals compared to paper?

The webinar shares benchmark data showing an 88% reduction in approval workflow durations when organizations move from paper-based binder routing to digital workflows. Additional results include a 60% reduction in process cycle time and a 40% reduction in overall process steps, based on Kneat customer case studies.

How does digital C&Q help with regulatory audits?

Digital C&Q shifts your organization from reactive audit preparation to continuous audit readiness. Structured records enable instant retrieval through search rather than physical storage hunts. Exportable audit trails align with ALCOA data integrity principles, and real-time analytics provide complete traceability across all validation activities.

Can multi-site organizations standardize C&Q without losing local flexibility?

Yes. The webinar describes a scalable model built on globally defined work processes and centrally managed templates. Each site starts from the same approved content but configures its own approval workflows and selects test cases from drag-and-drop libraries based on local system types. This approach harmonizes processes while preserving the operational autonomy each site needs.

What kind of data can digital validation systems unlock from documents?

Validation documents contain valuable information that often stays trapped in static text. Digital systems convert elements like deviation data, root cause classifications, asset attributes, and approval cycle durations into queryable, structured data. This creates opportunities for trend analysis, bottleneck identification, and even predictive insights — such as identifying recurring faults that suggest adjusting validation frequency or maintenance strategy.

Does the platform meet 21 CFR Part 11 and Annex 11 requirements?

Yes. The webinar references compliant electronic signatures, built-in data integrity controls, and security options including single sign-on and multi-factor authentication. These capabilities support both 21 CFR Part 11 and Annex 11 electronic records requirements for regulated life sciences environments.

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