Built for validated GMP software environments
Katalyze AI is designed from the ground up for 21 CFR Part 11, ICH Q10, and EU Annex 11 requirements. Full IQ/OQ/PQ documentation, validation protocols, and a QA agreement are provided at contract signing.
The regulations that govern your QMS
Katalyze AI directly addresses the documentation and control requirements under the frameworks your quality team operates within.
Katalyze AI is designed to support 21 CFR Part 11 electronic record requirements. Electronic signature workflows include identity authentication, non-repudiation controls, and record integrity protections. Audit trail is automatically generated, immutable, and exportable on demand.
- Unique user identities, password controls, and session management
- E-signatures with name, date, time, and meaning of signature
- Tamper-evident audit trail for every create, modify, and delete action
- Record retention and archival in WORM-compliant storage
ICH Q10 requires a documented pharmaceutical quality system that covers batch manufacturing, deviation management, CAPA, and change control. Katalyze AI provides the workflow and documentation infrastructure for the deviation and CAPA elements of the Q10 framework.
- Deviation intake, investigation, and CAPA linkage
- Root cause analysis documentation
- Effectiveness check scheduling for closed CAPAs
- Trending and periodic review data export
EU GMP Annex 11 governs computerised systems used in regulated manufacturing, including validation, data integrity, and business continuity requirements. Katalyze AI is designed to the Annex 11 framework and provides the supplier documentation required for your validation.
- Supplier assessment and quality agreement available
- Risk-based validation documentation (IQ/OQ/PQ)
- Disaster recovery and business continuity documentation
- Change control notifications for platform updates
We have done the validation work for you
Our validation package is designed to reduce your internal validation timeline from months to weeks.
Installation Qualification (IQ)
Documented evidence that the system is installed correctly in your environment, covering software version, infrastructure configuration, and integration endpoints.
Operational Qualification (OQ)
Documented evidence that system functions operate as intended across the defined operating range, including all GMP-critical functions.
Performance Qualification (PQ)
Documented evidence that the system performs consistently in your production environment, using your product data and workflows.
Quality Agreement
A formal quality agreement covering roles, responsibilities, change control, and audit rights. Required under Annex 11 and recommended practice for 21 CFR Part 11 environments.
Risk assessment
GAMP 5 category 4 software risk assessment and traceability matrix, mapping system functions to regulatory requirements and control measures.
Change notification
Advance notification of platform updates with impact assessment. Major updates include updated validation documentation before deployment to your environment.
ALCOA+ from intake to archive
Every record in Katalyze AI satisfies the ALCOA+ principles required by FDA and EMA data integrity guidance.
Attributable
Every data entry is attributed to a named, authenticated user with timestamp. System-generated entries are attributed to the Katalyze AI service account with version.
Legible and permanent
Records are stored in standard formats readable without special decoding. Archived records are retained in WORM storage and are not alterable after archival.
Contemporaneous
All timestamps are UTC-synchronized and assigned at the moment of record creation or action. Retroactive entries are structurally prevented.
Original and accurate
The first entry of any value is preserved as the original. Subsequent corrections are recorded as amendments with attribution, never overwrites.
Complete
Records include all data generated during the process, including intermediate steps, machine readings, and operator observations. No selective retention.
Consistent and enduring
Record integrity is verified at each retrieval using cryptographic checksums. Records are retained for the full regulatory retention period defined in your configuration.
Request the full validation documentation
Our validation package is available under NDA prior to contract. Request it in a discovery call and we will walk through every document with your QA team.