Unalterable audit trails, version control, and ALCOA+ principles enforced at every layer — from database to document to signature.
The system maintains detailed, unalterable audit trails of all activities. Secure, computer-generated, time-stamped audit trails independently record the date and time of every operator entry and action. Record changes never obscure previously recorded information, and audit trails are available for agency review and copying.
Valkit.ai provides version control for all validation documents, ensuring only the most current version is used for execution and review. The system blocks unauthorized version changes, generates new versions with unique identifiers, and maintains a complete status history for all documents to track progress and changes over time.
Authority checks ensure only authorized individuals can use the system, sign records, access operations, alter records, or perform operations. Role-based access control with MFA and SSO integration, combined with Row-Level Security for tenant isolation, ensures data confidentiality across organizations.
Data is protected through AES-256 encryption at rest and TLS 1.3 in transit across every infrastructure layer. Point-in-Time Recovery provides a 2-minute RPO (database changes logged every 2 minutes), with a recovery period of up to 7 days (configurable to 14 or 28 days). Automated daily backups and geographic data residency options support global compliance requirements.
Attributable, Legible, Contemporaneous, Original, Accurate data by design
Time-stamped, computer-generated records of all user actions
Create, modify, maintain, archive, retrieve, and distribute records
Log, categorize, and track resolution of deviations with corrective actions
Non-repudiable signatures linked to their respective electronic records
Validated data entry tables with input validation and risk scoring
Unalterable audit trails, ALCOA+ principles, version control, and e-records enforced from database to document to signature. Valkit.ai aligns with FDA Data Integrity Guidance (2018), PIC/S (2021), WHO TRS 996 Annex 5, EMA Q&A, and ISPE GAMP Data Integrity by Design.
FAQ
ALCOA+ principles are enforced from the database to the document to the signature, with unalterable audit trails, version control, access controls and electronic records.
Secure, computer-generated, time-stamped entries for every operator entry and action. Changes never hide earlier information, and the audit trail is available for agency review and copying.
FDA Data Integrity Guidance (2018), PIC/S (2021), WHO TRS 996 Annex 5, EMA Q&A and ISPE GAMP Data Integrity by Design.
With AES-256 encryption at rest and TLS 1.3 in transit, daily automated backups, and point-in-time recovery with a 2-minute recovery point, kept for 7 days by default and configurable to 14 or 28.