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Resource library

Our regulatory position papers and whitepapers on digital health technologies in clinical trials. Three download without an account; a free account opens the rest after email confirmation and personal approval, usually within one business day. No sales calls attached.

12 papers in qointa Services brochures
CSV Maintenance — service brochure qointa Services brochures Free 2 pages

CSV Maintenance — service brochure

Keeping validated systems in a validated state — periodic review, change control and revalidation for computerised systems.

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Computer System Validation — service brochure qointa Services brochures Free 2 pages

Computer System Validation — service brochure

Computer system validation across the full lifecycle, from validation planning and risk assessment through to execution and reporting.

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Data Integrity — service brochure qointa Services brochures Free 2 pages

Data Integrity — service brochure

Data integrity services built on ALCOA+ — governance, gap assessment, remediation and controls across GxP data.

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Digital Transformation — service brochure qointa Services brochures Free 2 pages

Digital Transformation — service brochure

Digital transformation support for clinical and quality operations — target operating model, process redesign and adoption.

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Information Systems Compliance — service brochure qointa Services brochures Free 2 pages

Information Systems Compliance — service brochure

Information systems compliance — bringing IT processes, controls and documentation into line with GxP expectations.

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Information Systems QMS Audit — service brochure qointa Services brochures Free 2 pages

Information Systems QMS Audit — service brochure

Information systems QMS and audit — internal audit, supplier audit and QMS readiness for IT organisations.

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Infrastructure Qualification — service brochure qointa Services brochures Free 2 pages

Infrastructure Qualification — service brochure

Infrastructure qualification and IT service management — qualifying the platforms and environments that GxP systems run on.

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Medical Device Software Development — service brochure qointa Services brochures Free 2 pages

Medical Device Software Development — service brochure

Medical device software development, from planning and requirements through risk management (ISO 14971), development and verification.

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Patient Engagement — service brochure qointa Services brochures Free 2 pages

Patient Engagement — service brochure

Patient engagement services that strengthen the patient–provider relationship to improve adherence, insight and outcomes.

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Quality & Regulatory Assurance — service brochure qointa Services brochures Free 2 pages

Quality & Regulatory Assurance — service brochure

Quality and regulatory assurance — QMS design, regulatory strategy and ongoing compliance support for life-science organisations.

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Strategy & Thought Leadership — service brochure qointa Services brochures Free 2 pages

Strategy & Thought Leadership — service brochure

Thought leadership, business and project strategy, development and implementation services for life-science companies.

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qointa service overview qointa Services brochures Free 1 page

qointa service overview

qointa's full service portfolio across quality management, regulatory compliance, software development, contract research, patient engagement and digital transformation.

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