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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.

5 papers in qointa Services brochures tagged “Validation”
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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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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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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