Domains targeting keyword fda 21 cfr part 11

JEKSON VISION, provides 21 CFR Part 11 ready vision inspection systems for the pharmaceutical, nutraceutical and cosmetic industries.

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Electronic Batch Records Simplified

Document Control Software, Document Management Software Systems: quality and document management software for electronic document control, workflow, collaboration, electronic SOP, corrective actions, preventive actions CAPA, nonconformance for ISO 9000, ISO 14000, QS-9000 and FDA 21 CFR Part 11, GxP-compliant companies. Offer full cycle FDA software validation services including test plans and consulting help with 21 CFR Part 11, ISO certification and more.

Ofni Systems - Software, consulting and compliance training on 21 CFR Part 11, Electronics Records and Electronic Signatures for FDA-regulated companies.

Specialised Research Data Management Service Provider

Medical device expert with engineering, science and business degrees, 20 years experience in the medical, pharmaceutical, biotech, and regulatory industry who worked with companies around the world.

Clinical Research Technology è una struttura di ricerca a contratto dedicata alla gestione di studi clinici secondo gli standard di Buona Pratica Clinica (GCP-ICH) tramite l’utilizzo estensivo delle nuove tecnologie informatiche ed Internet in particolare Clinical Research Technology is a company oriented to the management of clinical trials according to Good Clinical Practice standards and respecting its own and the Customer’s SOPs (constantly updated and monitored)

CSV Training and consulting. Download from the largest library of validation templates and FDA Warnings. Our 21 CFR Part 11 experts can validate for you.

Bio SB performs R&D, production, distribution and marketing of unique products for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), Liquid-Based Cytology (LBC) and Polymerase Chain Reaction (PCR) technologies that meet the highest international standards for applications in Molecular Pathology, Cancer Research, Microbiology, Immunology and Genetics. BIO SB manufactures and develops products in accordance with FDA QSR 21 CFR Part 820 cGMP.

Australian Designed and Developed, Paradigm 3 is “out-of-the-box” or KIT Compliance Management software that allows Administrators to construct and build an efficient electronic compliance management system.

PharmaReady™ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite. PharmaReady is specifically designed for regulated Life Science organizations where ease of installation, ease of use, compliance and affordability are primary business drivers. PharmaReady is available is in both on-site and remote-hosted implementations.

Specialised Research Data Management Service Provider