Quality, security & trust

Role boundaries

QData Intelligence is a specialist advisor and delivery partner. Regulator decisions, notified-body assessments, certification, clinical care and CRO-of-record stay with the client unless a written contract defines a specific role. Credentials are shared under diligence, not as brochure badges. Regulatory writing and procedure support are not legal advice.

Security-certified team

QData Intelligence includes security-certified specialists who support product engineering, infrastructure hardening and operational security as scoped in the engagement. Specific credentials and scope are shared under contract and for due diligence; individual certification numbers are not listed on this marketing site.

• Secure development and change-control practices proportional to product risk
• Infrastructure and application hardening aligned to the client’s threat model and regulatory context
• Coordination with the client’s security and quality functions, including their accountable security officer

Security reports: [email protected] (also in .well-known/security.txt where published).

Managed operations and maintenance

Where agreed in the SOW, we can provide ongoing application maintenance and operations — not only initial build — on infrastructure configured for the client’s regional and sector expectations. Availability, SLAs and data-processing roles are defined per contract; this brochure site is not an order form.

• United States — HIPAA-aligned hosting and operational practices where the client acts as covered entity or business associate; BAAs and HIPAA compliance accountability remain with the client
• European Union — infrastructure and operations aligned with applicable GDPR and health-sector / medical-device context as scoped; the client remains accountable for their conformity and privacy programme
• Canada — infrastructure aligned with applicable federal and provincial privacy expectations (including PIPEDA themes) as scoped

Company-level “HIPAA certified” status is not claimed for QData Intelligence; BAAs and covered-entity obligations stay with the client. See also Medical software for engineering and HIPAA themes in product context.

Documentation discipline

On engagements that require it, we work toward artefacts clients can own inside their quality and document-control systems: clear owners, version history and traceability between need, requirement, design and verification where software or device documentation is in scope.

• Deliverables are aligned to the client’s QMS; ISO certification of the client’s organisation remains theirs
• Medical software work applies IEC 62304 / ISO 14971 / ISO 13485-aligned practices as scoped (see Medical software)
• “Audit-ready” means structured for the client’s processes and document control

Clinical data in contracted work

Where a biostatistics engagement includes identifiable clinical data, we use a segregated workflow: raw PHI access is limited to a HIPAA-certified biostatistician in an encrypted, access-controlled environment; the wider project team works on de-identified datasets (US: Safe Harbor where agreed; EU: pseudonymisation/anonymisation per client instruction). Details: Biostatistics — clinical data.

Privacy on public channels

The public website and contact form are for business enquiries. Clinical data and confidential packs use agreed channels after contract — see Contact and Privacy.

Cookie and tracker posture for this brochure site is described on Cookies.

Secure document exchange

Confidential materials should move only through agreed secure channels after appropriate arrangements — not via unrestricted public upload. We can arrange a channel after agreements.

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