Validation Use Cases
Computer system validation (CSV) software
Regulators have highlighted paper-based validation as a potential CSV compliance pitfall. Learn how to build risk-based validation to protect data integrity and compliance with Kneat’s CSV software.
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Efficient change control
Frequent software updates and evolving business needs force validation teams into continuous revalidation cycles, straining resources and increasing risk. Kneat streamlines change control enabling you to reduce change-assessment turnaround and change-implementation time.
Ensure data integrity
Data integrity is often challenging, yet critical to maintain. Kneat enforces compliance through secure and traceable data integrity checks, safeguarding regulatory adherence.
Reach industry 4.0 faster
Kneat accelerates computer software assurance by reducing review-approval cycle times and supporting flexible, risk-based testing. Ensuring validation professionals keep pace with Industry 4.0’s expanding system landscape.
Remote freedom
Kneat enables 100% remote computer systems validation, reducing deployment time and costs for global systems.
Challenges
Complex, evolving systems
Computer systems validation professionals face rising system complexity and AI-driven technologies, and evolving regulations. We understand the struggle to manage complexity, ensure data integrity, and eliminate inefficiencies as computer systems evolve.
Other common challenges include:
- Efficient testing across integrated systems
- Validating globally deployed and used computer systems
- Adapting to evolving regulations and new technologies
THE SOLUTION
The complete digital validation solution
Kneat is trusted by 8 of the world's top 10 life sciences companies. Digitalize and manage any validation process your way, in one easy-to-use, end-to-end solution.
- Create, template, generate, review-approve, test-execute, and trace
- Compliant electronic signatures and audit trail
- Real-time in-document collaboration
- Comprehensive reporting
- Powerful document automation
- Audit readiness, anytime
BENEFITS
Computer system validation, your way
Kneat enables a document or data centric approach to computer systems validation, giving you the flexibility to validate systems your way. Drive efficiency, compliance, and data integrity in complex, evolving computer systems across global and integrated environments more easily, with Kneat.
- Reduce global system deployment time for SAP S4 Hana by 18%
- Flexibility to easily scale testing appropriately to risk and achieve CSA
- Validate any computer system, 100% remotely
It’s what I really wanted, the ability to still author and execute in the traditional manner, but not having the ‘on paper’ anymore.
Manager IT Compliance, Fujirebio Diagnostics, Inc
Book a demoRevolutionize your validation
Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.
Talk to an expertCustomer Success
Case studies
Enabling an efficient global computer system deployment
The customer, a global healthcare packaging company with operations in North America, Central America, Europe, and the UK, looked for a flexible digital solution to...
use cases
Computer System Validation
Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale
Fujirebio Diagnostics cut CAPA change control time in half and is saving 40% on test script execution, translating to significant savings.
use cases
Audit- Computer System Validation
Improved productivity and reduced costs
A growing niche Contract Research Organization with operations in Europe and North America sought to implement a validation solution that freed its skilled team from...
use cases
- Audit
- Computer System Validation
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
CSV Life - Cycle & Core Deliverables
CSV work begins long before testing and includes a large host of documents that detail user requirements, functionality, process plans, risk assessments, and more. Kneat Gx provides templates for every document you need and automatically builds a traceability matrix so you can link requirements, risks, and tests to get the document you need, when you need it.
Risk-Based CSV & Computer Software Assurance
The FDA advises a modern take on CSV, called Computer Software Assurance (CSA). This is a risk-based approach to validation which aligns with new GAMP 5 best practice. Under CSA, a company conducts validation efforts in proportion to the risk level of the system. Using Kneat and risk-based validation, Fujirebio Diagnostics Inc was able to cut CSV testing time by 46%.
| # | Software Category | Risk Level |
|---|---|---|
| 1 | Infrastructure Software | Lower Risk |
| 2 | Firmware (now an obsolete category) | N/A |
| 3 | Standard, Non-Configured Software | Lower Risk (Vendor) |
| 4 | Configurable, Off-the-Shelf (COTS) Software | Moderate to High Risk |
| 5 | Custom-Developed Software | High |
Which Systems Need Validation?
Any system related to Good Manufacturing Practices requires validation. The GAMP 5 guidance established four categories of system:
Kneat has a variety of features to streamline CSV, including template libraries, online test execution, risk, requirement, and test traceability, and the ability to leverage vendor tests and evidence to support risk assessment.
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Results
CYCLE TIME REDUCTION
Kneat is proven to reduce cycle time by an average of 50% or more in multiple customer authored case studies.
CSAT Score
97% of our customers rate our customer support as either ‘Very Good’ or ‘Excellent.’
PLAN TO RENEW
Customer feedback via industry analyst SoftwareReviews.
Pharma
Our expert team and industry-leading solution help pharma quality assurance and validation teams overcome compliance and operational challenges every day.
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.
Biotechnology
Overcome complexity across process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations.
Medical Device
Transform the efficiency and compliance of design, process, software, cleaning, equipment, packaging, sterilization, and test method validation.
Contract Manufacturing
Accelerate release to production and ensure customer confidence with more efficient, transparent documentation. Perform technology transfer and meet deadlines faster and easier.
Does Kneat support risk-based validation and the FDA’s Computer Software Assurance (CSA) model?
Yes. CSA is a named application area in Kneat Gx (“Computer System Validation (CSV) / Computer Software Assurance (CSA)”).
Are IQ/OQ/PQ templates built in?
Kneat lets you store pre-approved templates—including IQ, OQ and PQ—so teams can generate complete validation “document packs” quickly.
Can Kneat validate SaaS or other cloud-native systems?
Kneat is built to handle any validation requirement at any stage in the lifecycle. As such, it can validate other SaaS and cloud-native systems effectively.
Does Kneat meet 21 CFR Part 11 & EU Annex 11 (e-signatures, secure audit trail)?
he platform is explicitly validated to Part 11/Annex 11, providing unique user IDs, electronic signatures, full version control, just to name a few features. Kneat Gx addresses every ALCOA++ principle and is built to secure compliance across the validation lifecycle.
Is there an open API to plug into ALM/QMS tools (e.g., Jira, SAP)?
Yes. Kneat exposes REST APIs for importing and exporting documents, drawings and data to external systems.
Can distributed teams review/approve remotely?
Yes—secure cloud access enables real-time, parallel or sequential remote reviews and approvals.