Equipment validation
Ensure equipment is validated, tested, documented, and maintained to meet operational and regulatory requirements. Assuring consistent and efficient performance.
Solutions for Pharma
Pharmaceutical validation software that delivers
Trusted by 8 of the top 10 global Pharma companies — Kneat Gx cuts validation costs by up to 50% and helps standardize processes across sites.
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Challenges
Protecting compliance & patient safety
Addressing changing regulation, ensuring data integrity, and validating complex processes are key to validation in the pharmaceutical industry. Common challenges include maintaining the entire equipment lifecycle and ensuring consistent product safety and quality.
Evolving standards
The pharmaceutical sector faces strict, evolving regulations like the FDA's cGMP. Compliance demands continuous updates to validation processes, detailed documentation, and consistent quality assurance efforts.
Data integrity assurance
Ensuring data accuracy and integrity is vital. Validation experts must establish strong systems to prevent breaches and ensure compliance, as lapses risk regulatory penalties and compromise reliability. Kneat assures data integrity with tamper-proof ALCOA++ features.
Complex process validation
Consistently achieving quality and reproducibility in pharma processes requires vigorous testing and monitoring to maintain control and meet standards. Kneat streamlines process validation, providing real-time status visibility and automated traceability for greater efficiency and compliance.
Equipment life cycles
Ensuring pharmaceutical equipment meets regulatory standards requires thorough qualification to maintain process control and compliance. Kneat centralizes C&Q and equipment validation in one platform. Enabling you to leverage equipment metadata across the lifecycle easily.
THE SOLUTION
The complete digital validation platform
Kneat is designed for and trusted by the Pharma industry. Digitalize and manage any validation process your way, in one easy to use, end to end solution.
- Create, template, generate, review-approve, test-execute, trace & more
- Compliant electronic signatures and audit trail
- Real-time in-document collaboration
- Comprehensive reporting
- Powerful document automation
- Audit readiness, anytime
BENEFITS
Create value beyond compliance
Kneat creates value beyond compliance by transforming validation efficiency, ensuring audit readiness, delivering global standardization and reducing costs — helping you go to market faster, with confidence.
- Proven to increase speed to market by up to 20%
- Proven to reduce cycle time by over 50%
- Proven to reduce validation cost by 35%
We were able to demonstrate over 50% cycle time reduction…and process simplification from 15 steps to 8 … because of Kneat we minimized the number of systems we used from 5 to 2.
- Global Executive Director, MSD
Download case studyRevolutionize your validation
Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.
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Case studies
Merck Sharp & Dohme (MSD) reduced validation time by 50%
MSD digitized seven validation processes globally, reducing cycle times by 50%, process steps by 46%, and replacing three QMS systems.
use cases
Analytical Instrument Validation
Audit
Cleaning Validation
Commissioning & Qualification
Computer System Validation
Equipment Validation
Facilities & Utilities Validation
Process Validation
Accelerating CQV: streamlining processes for a paperless future
As part of its top-down digital strategy, a Top 10 global pharmaceutical and healthcare company implemented Kneat to digitize CQV and AIQ, to support its...
use cases
- Analytical Instrument Validation
- Audit
- Commissioning & Qualification
Digitalizing validation worldwide
A global biopharma leader digitalized validation with Kneat Gx across 25+ global sites and thousands of users, achieving 24/7 visibility, audit-friendly processes, and faster product...
use cases
- Analytical Instrument Validation
- Cleaning Validation
- Commissioning & Qualification
- Computer System Validation
- Equipment Validation
Method Validation
Top 10 pharma leader streamlines CQV
Pharma leader standardized C&Q with Kneat, achieving 20–25% cost savings and 30–40% reduction in validation cycle time.
use cases
- Analytical Instrument Validation
- Commissioning & Qualification
Featured use cases
Process validation
Ensure manufacturing processes are validated, controlled, and maintained to consistently produce products meeting predefined quality standards.
Audit readiness
Maintain a state of continuous compliance and documentation accuracy to ensure preparedness for regulatory inspections and all forms of audits.
Contract Manufacturing
Accelerate release to production and ensure customer confidence with more efficient, transparent documentation. Perform technology transfer and meet deadlines faster and easier.
Medical Device
Transform the efficiency and compliance of design, process, software, cleaning, equipment, packaging, sterilization, and test method validations.
Biotechnology
Overcome complexity across process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations.
Consumer Health
Get more products to market faster without compromising quality. Improve the efficiency of the entire validation lifecycle for all your consumer health products.
Featured resources
The cost of delaying digital validation
This overview shows you why delaying your digital validation can have long term consequences, including letting your competition get too....
Operational Readiness in Pharma
Kneat and PM Group share how digital validation reinforces operational readiness to build concrete GMP compliance and accelerated tech transfer....
60 minutes
Michael Sweeney, Fintan Coady
USP <665> Unlocked: Your 2026 Compliance Playbook
See how to meet USP compliance by 2026 with expert guidance from ALTEN & Kneat.
60 minutes
Olivia Calder, Stan Van Kerkhoven
How does Kneat help pharmaceutical companies meet complex regulatory requirements for software validation?
Kneat provides a robust system for software validation in pharmaceuticals, built to meet strict regulatory requirements such as FDA 21 CFR Part 11, GAMP 5, and Annex 11, while aligning with current good manufacturing practice (CGMP). We offer complete validation services, ensuring your software system and validation projects comply with the highest quality standards in the pharmaceutical sector.
How does Kneat support the full lifecycle of a pharmaceutical validation project?
Our digital validation software Kneat Gx covers the entire lifecycle of a validation project, from user requirement specifications and system design, through installation qualification, operational qualification, and performance qualification. Our platform enables efficient SOP and approval workflows, strengthens quality control, and generates audit-ready documented evidence for all assessments — to ensure adherence to quality at every stage.
How does Kneat Gx ensure data integrity and compliance with FDA regulations for electronic records?
Kneat Gx guarantees complete data integrity and compliance with FDA regulations through secure electronic signatures and management of electronic records. Our digital validation solution provides essential documented evidence for every validation project, supporting food and drug administration compliance and proving the suitability of your software for pharmaceutical use.
Is Kneat Gx scalable and customizable for different pharmaceutical production environments?
Yes, Kneat Gx is a scalable and customizable pharmaceutical software solution designed to be suitable for a wide range of needs across the pharmaceutical sector and within any production environment. Our platform supports efficient risk management and allows you to prioritize your validation projects, including CSV for GxP-critical systems like SCADA — enabling flexible software life cycle management.