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PSC Biotech® & Kneat

PSC Biotech®

PSC Biotech® & Kneat

PSC Biotech® has partnered with Kneat to provide digital validation solutions for life science companies. As a global life science consulting firm, PSC Biotech® integrates Kneat’s technology into our compliance and validation services.

Kneat is the leading digital validation platform for highly regulated industries and is the chosen solution for 12 of the world’s Top 15 pharmaceutical companies.

Proven to eliminate paper from processes, reduce cycle times by 50% or more, and enhance audit readiness.

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Why Kneat?

Efficient, Effective, and Compliant Validation

Digitalize validation faster, on-budget, and for companies of all sizes

Reduces equipment changeover time by as much as 85%

  • Found in the following independent customer benchmarking study. Used Kneat for: Commissioning & Qualification, Equipment Validation
 Reduces validation life cycle time by over 50%

  • As found by multiple independent customer benchmarking studies. Used Kneat for: Commissioning * Qualification
Reduces labour-hours and cost by 50-65%

  • Found in the following independent partner benchmarking study. Used Kneat for: Commissioning & Qualification, Equipment
 Saved $0.81M-USD ERP Deployment

  • Found in the following independent partner benchmarking. Used Kneat for: Computer System Validation

 

Kneat Solutions

Quality, Compliance, and Audit Readiness

Quality & Compliance ALCOA+ principles built into standardized processes, automatic audit trails, real-time global visibility, and traceability.
Audit Readiness Kneat Gx ‘Collections’ feature allows Kneat users to send approved documents to a dedicated staging area where non-standard users, such as auditors, can view and interact with the content. This expedites audit preparation, reduces human error, and enables responses to remote audits.
Cost Savings Reduced labor hours, cycle times, and overhead while accelerating time to market.
Scalability Scale across global sites and manage any validation process.
Sustainability Complete removal of paper, reduce required travel, and leverage power-efficient servers powered with 100% renewable energy by 2025.

 

Digital Validation Offerings

Data integrity Enables 21 CFR Part 11 / Annex 11 compliance
Ease of Use Intuitive user interface results in fast deployment and user adoption; easy configurability means you map your process on the Kneat platform
Smart Validation User defined templates automate the development of validation documentation packs. Users can embed video or audio files into test execution cells.
Online Test Execution Execute testing digitally on your device, complete with integrated deviation lifecycle management and all test evidence.
Document Management All your document files such as Word, PDF, Excel, images, and more may be stored, controlled, reviewed, and approved within Kneat Gx
Integration APIs Kneat Gx APIs enable integration with all your key software systems e.g., import/export documents/drawings/data
Dashboard Reporting Run status reports or create progress reports using detailed filters. Gain real-time visibility at macro and micro levels.

Partner with PSC Biotech® Today!

Partner with PSC Biotech® and Kneat to transform your validation process with cutting-edge digital validation solutions. Our seamless integration of Kneat Gx eliminates paper-based inefficiencies, ensuring compliance, accuracy, and efficiency across your validation lifecycle.

With PSC Biotech®’s industry expertise and Kneat’s powerful technology, we help life sciences companies achieve faster validation cycles, improved data integrity, and regulatory compliance with FDA, EMA, and global standards.

Elevate your validation with PSC Biotech and Kneat today!

LIFE SCIENCE EXPERTISE ON DEMAND

What makes PSC Biotech® the partner of choice for leading life science companies? It’s our full-service approach to ensuring your facilities, equipment and processes meet regulations set by leading regulatory bodies. Access the full spectrum of software and service solutions your company needs to thrive. Contact a PSC expert today.

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