Quality management
ISO 9001
Process discipline designed to support consistent delivery and continuous improvement.
Compliance and trust
Quality, security, and regulated workflow readiness.
diCELLa is positioned for enterprise clinical environments that require disciplined quality management, secure information handling, and workflows aligned with regulated trial operations.
Information security
ISO 27001
Security controls and operating practices aligned with enterprise expectations.
Electronic records
21 CFR Part 11
Product and workflow posture built around auditability, integrity, and controlled access.
Clinical operations
GCP + HIPAA
Operational trust messaging intended for sensitive clinical workflows and regulated study delivery.
Computerized systems
GAMP5
Work practices aligned with the ISPE GAMP5 approach to computerized system validation.
Data protection
GDPR
A security and privacy posture shaped around sensitive medical and clinical study data.
ISO standards
Management systems that support reliable delivery and secure operations.
diCELLa operates by ISO 9001 and ISO 27001 standards granted in November 2023, supporting quality management, secure information handling, and disciplined software delivery for clinical research environments.
ISO 9001:2015
Quality management focused on consistency and continuous improvement.
Design, production, sales, and after-sales support of software for the medical industry of clinical research.
ISO 27001:2013
Information security controls suitable for enterprise clinical software.
Information security management in the field of design, production, sales, and after-sales support of software for additional equipment in accordance with SoA of October 1, 2023.
Regulated workflows
Positioned for the realities of clinical trial compliance.
Beyond ISO positioning, diCELLa communicates readiness for the regulatory and operational controls enterprise trial teams expect when selecting a platform.
FDA-oriented workflows
Structured operating flows designed to support regulated clinical execution and inspection-minded delivery.
21 CFR Part 11 alignment
Trust messaging centered on electronic records, audit trails, signatures, and controlled system behavior.
GDPR and HIPAA-aware posture
A product story that reflects the care required when workflows intersect with sensitive healthcare, patient-related, and personal data.
ICH GCP (E6) operations
Support for the quality, documentation, and oversight expectations that shape day-to-day clinical study execution.
ISPE GAMP5 and CSV
Work practices aligned with the 2022 renewed ISPE GAMP5 guideline, including computerized system validation expectations.
EU GMP Annex 11
Computerized systems posture for regulated environments where system control, data integrity, and operational traceability matter.
Compliance culture
Security practices supported by trained people and continuous improvement.
The previous compliance page emphasized that diCELLa protects medical data through both standards and operating habits. The new page keeps that message visible for sponsors, CROs, and research teams evaluating trust.
GCP-trained team
Developers and customer-facing team members are positioned around GCP awareness so clinical software decisions stay connected to research obligations.
Data security training
Security and data protection training reinforces procedures for handling confidential clinical and medical data responsibly.
Medical data protection
Patient and study data security remains central to the compliance story, from software design to support and ongoing operations.
Regular security improvement
diCELLa communicates an ongoing practice of implementing, testing, and improving security solutions rather than treating compliance as a one-time checkbox.