Kneat Gx: Digital Validation Software for Life Sciences
Kneat helps life sciences organizations manage validation processes electronically. The platform is designed to support compliance with 21 CFR Part 11 and Annex 11 requirements.
At a glance
- Category
- Operations
- Best for
- Pharmaceutical companies, Biotechnology firms, Medical device manufacturers, Contract Manufacturing Organizations (CMOs), Life sciences organizations in GMP regulated environments
- Pricing
- Pricing was not clearly available from the provided evidence. Buyers should confirm current pricing on the vendor website.
- Key use cases
- Equipment Validation, Computer System Validation (CSV), Analytical Instrument Validation, Commissioning and Qualification, Audit Readiness
- Official website
- kneat.com
Kneat Gx is a cloud-based platform designed to transition validation processes from paper to a digital format. It is built for the life sciences sector, including pharmaceutical, biotechnology, and medical device companies.
The software supports various validation activities, such as equipment, computer system, and analytical instrument validation. Using a no-code configuration, it helps businesses set up specific workflows without requiring custom programming.
The platform includes data integrity controls such as time-stamped audit trails and role-based access. These features are intended to help companies maintain audit readiness for regulatory inspections.
Buyers should confirm that this tool is tailored for GMP regulated environments; those in non-regulated industries may find these specialized compliance features unnecessary.
Key Features
Supports the transition of validation processes from paper records to digital documentation.
Allows users to create and manage validation workflows without writing code.
Designed to support 21 CFR Part 11 and Annex 11 electronic records requirements.
Provides records of changes to support data integrity.
Supports controls for viewing or editing specific parts of the validation process.
Provides AI capabilities to support digital validation use cases.
Use Cases
Testing and documenting that equipment meets operational and regulatory requirements.
Validating and maintaining computer systems in compliance with regulatory requirements.
Qualifying and calibrating instruments to support traceable and reliable results.
Verifying that facilities and systems are installed and operated according to requirements.
Maintaining documentation accuracy to help prepare for regulatory inspections.
Best For
Pricing
Pricing was not clearly available from the provided evidence. Buyers should confirm current pricing on the vendor website.
FAQ
It is built for life sciences organizations, including those in pharma, biotech, medical devices, and contract manufacturing.
The platform is designed to support 21 CFR Part 11 and Annex 11 electronic records requirements.
It supports equipment validation, computer system validation (CSV), analytical instrument validation, and commissioning and qualification.
Source category: Operations
Source subcategory: Life Sciences Validation
