End-to-end Computer System Validation with AI-powered risk assessment, electronic signatures, and complete traceability — built for GxP-regulated environments.
Valkit.ai manages the full validation lifecycle from plan through summary report. Create validation packages that include plans, product requirements, functional risk assessments, operational qualifications, trace matrices, and summary reports — all within a single, connected workflow.
The platform uses a five-level, three-attribute risk model based on the recommendations of the FDA's FICSA team and ISPE GAMP Data Integrity by Design good practice guide. Risk scores from 1–5 are automatically derived from impact severity and implementation complexity, driving test rigor proportionally.
Valkit.ai supports electronic signatures as a legally binding equivalent of handwritten signatures. The system maintains records of all signatures including printed name, date/time, and meaning. Authority checks ensure only authorized individuals can sign, access, or alter records.
A built-in trace matrix maps every requirement to its corresponding test case, ensuring traceability throughout the validation lifecycle. Requirements can be linked to risks and test steps automatically, and the traceability matrix displays in both requirement-centric and test case-centric formats.
Structured plans with regulatory references and stakeholder assignments
Manual, upload, or AI-generated requirements with risk scoring
Five-level risk rating with automatic score derivation
Scripted test execution with deviation management
Automatically drafted summary reports consolidating validation outcomes
Requirement-to-test mapping in multiple display formats
Most customers consider Valkit.ai to be a GAMP Category 1 or Category 3 tool under ISPE GAMP 5 Second Edition, considered a COTS product with low patient safety/product quality impact. However, this is ultimately a customer decision — some choose Category 3 or 4.
FAQ
CSV is the documented process of proving a computerized system does what it is intended to do in a GxP-regulated environment. Valkit covers the lifecycle end to end: validation plans, requirements, functional risk assessments, scripted test execution, trace matrix and summary reports.
Valkit uses a five-level, three-attribute risk model based on recommendations from the FDA FICSA team and the ISPE GAMP Data Integrity by Design good practice guide. Risk scores from 1 to 5 are derived automatically.
Valkit supports electronic signatures as the legally binding equivalent of handwritten signatures, recording the printed name, date and time, and meaning of every signature, with authority checks on who can sign.
Most customers consider Valkit a GAMP Category 1 or Category 3 tool under ISPE GAMP 5 Second Edition, as a COTS product with low patient safety and product quality impact. The final categorization is the customer’s decision.