Security
Trust is a quality attribute.
DQMS and Yuktav are designed for GxP use: Part 11 and Annex 11 technical controls, a validation package, and operational security that a quality and IT team can review together.
Data integrity
Records are attributable, contemporaneous, and complete. Audit trails are on by design. Electronic signatures carry meaning. Exports for inspection do not silently omit history.
Access
Role-based access, SSO, session controls, and environment segregation between validation, training, and production. Least privilege is the default, not a workshop.
Encryption
TLS in transit. Encryption at rest. Key management kept out of application code. Backups inherit the same controls as live data.
Validation
A risk-based CSA approach aligned with GAMP 5. Specification, testing, and IQ/OQ evidence so your validation team is not reverse-engineering the product.
Operations
Change management for the platform itself, monitored availability, and a documented incident path. Quality software should be as boring in production as it is careful in design.
Privacy
We collect what we need to run the service and respond to you. We do not sell data. See the privacy notice for the legal detail.
What we claim, carefully.
We design for 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO 27001-aligned practice. Certification status and hosting regions are confirmed in the security pack we share under NDA during evaluation — we do not print badges we have not earned.
45 minutes
Request the security and validation pack.
Forty-five minutes. Bring an SOP, a deviation, or a validation gap.
Book a demo