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Uncompromising Compliance. Unrivaled Integrity.

ISO 9001 ISO 9001: Quality Management Systems

  • What It Is The international gold standard for Quality Management Systems (QMS), establishing strict operational protocols, continuous improvement processes, and service delivery benchmarks.
  • Why It Protects You It ensures that Klevret delivers consistent, error-minimized software products. Every project follows structured workflows, clear design specifications, and rigorous quality assurance reviews, drastically reducing bugs and project delays.

ISO 27001 & ISO 27002 ISO 27001 & ISO 27002: Information Security Framework & Tactical Controls

  • What It Is The gold standard global duo for complete, end-to-end information security. ISO 27001 establishes the overarching management framework for risk governance, while ISO 27002 provides the specific operational, technical, and physical controls required to execute it.
  • Why It Protects You It guarantees that your proprietary code, intellectual property, and data are safeguarded by both high-level strategy and daily engineering practice. By combining ISO 27001 governance with ISO 27002 tactical controls, Klevret delivers strict access management, active threat mitigation, and clinical-grade security across your entire technical stack.

ISO 27017 ISO 27017: Cloud Security Controls

  • What It Is An advanced ISO standard specifying cloud-specific security controls for cloud service provision and architecture management.
  • Why It Protects You Protects your cloud-hosted platforms by enforcing strict multi-tenant isolation, cloud access logging, and secure infrastructure deployment. It ensures that sensitive health and corporate data hosted in the cloud remains completely secure and compartmentalized.

GXP GxP Compliance (Good Practices)

  • What It Is The mandatory quality framework governing Good Laboratory, Clinical, and Manufacturing Practices within the pharmaceutical and life sciences sectors.
  • Why It Protects You Eliminates legal and operational risks when deploying clinical apps or data portals. Klevret structures software lifecycles to be validation-ready, providing the necessary traceability matrixes and protocols (IQ/OQ/PQ) required to pass stringent regulatory inspections.

EU ANNEX 11 EU Annex 11 Compliance

  • What It Is The European regulatory mandate setting standards for computerized systems used in medicinal products and clinical trials.
  • Why It Protects You Safeguards your European operations by embedding automated audit trails, biometric/electronic signatures, role-based access security, and strict data integrity protections directly into your platform, ensuring full compliance with European Medicines Agency (EMA) standards.

21 CFR Part 11 21 CFR Part 11 Compliance

  • What It Is The FDA regulatory mandate setting standards for electronic records and electronic signatures used in pharmaceutical, biotech, and medical device software.
  • Why It Protects You Safeguards your US market operations by embedding immutable, time-stamped audit trails, secure electronic signatures, role-based access controls, and strict data integrity protections directly into your platform, ensuring full compliance with FDA inspection standards.