Computer system validation (CSV) (original) (raw)
Validation Use Cases
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.
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.
Common Validation Challenges
What is Computer System Validation (CSV)?
CSV is the documented process that proves a computer system impacting human health or product quality in life sciences is fit for its intended use. Mandated under FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5, CSV requires strict data integrity procedures and testing capabilities.]
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
Revolutionize your validation
Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.
Customer Success
Case studies
A global healthcare packaging company
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
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
Contract research company
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
Merck Sharp & Dohme
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
Enabling an efficient global computer system deployment
The customer, a global healthcare packaging company with operations in...
Fujirebio Diagnostics, Inc uses Kneat to provide CSV at scale
Fujirebio Diagnostics cut CAPA change control time in half and...
Improved productivity and reduced costs
A growing niche Contract Research Organization with operations in Europe...
Merck Sharp & Dohme (MSD) reduced validation time by 50%
MSD digitized seven validation processes globally, reducing cycle times by...
| # | 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 |
Related Resources
Computer system validation (CSV) insight
Explore expert insights on Computer system validation (CSV) with eBooks, webinars, case studies, and more.
Related resources
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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.
Solutions by industry
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.
Frequently asked questions
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.