News
Graphics in TESTIMATE
Scientific presentation graphics are now in TESTIMATE according to the new FDA Guidance for...
Gold Standard Design of Study Planning
Gold Standard Design of Study Planning: New Substance, Reference and Placebo. The new definition of...
New Statistical Procedures in TESTIMATE
Su-Wei test, Wei-Lachin procedure and Efron test in TESTIMATE. Also new exact binomial confidence...
FDA 21 CFR Part 11 - Inspection
The inspector: "idv system with high security computer and software is light years ahead of other...
The Solution
All components are harmonized with one another, only so is full security possible!
To be able to guarantee that all requirements respecting durable security for operation, outage, and access are fulfilled, all components (Hardware, Software, SOPs and concepts) must be harmonized and validated.
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The idv high security personal computer (PC) exploits technical possibilities in an optimal fashion and thus achieves complete conformity with the requirements in the GCP guidelines and FDA CFR 21 Part 11.
Among other things the idv hight security PC implements a mirrored hard disk, a backup-system, access protection using fingerprints, uninterrupted current supply, etc.
idv undertakes the complete configuration of the system: Hardware, Windows, Security-Guidelines, Users, Groups, system and application software, etc.
SOPs cover all relevant areas: assembly of the PCs, configuration of the system as previously described, validation, etc.
After completing the setup, we submit all programs for and users and groups to comprehensive testing and validation.
The result is a PD fulfilling all requirements in the relevant guidelines for the security of operaion, outage, and access and - ready for use!