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Validation Documentation Services
8 services found
Manufactured by:Covartim based inWatermael-Boitsfort, BELGIUM
At COVARTIM we are at your side in every step of the way from the early development of your device to its introduction on the market. Our services range from consulting assignments to in-house product development and include tailored-made trainings. We are here to support, reinforce and strenghten your ...
by:gempex GmbH based inMannheim, GERMANY
Documented evidence that shows that equipment and utilities are correctly installed, working reliably within predefined operating ranges and, as far as the final product is concerned, lead to the desired ...
by:Ofni Systems Inc. based inRaleigh, NORTH CAROLINA (USA)
Process, Design, and Equipment Validation are the formal processes for establishing objective evidence that systems consistently produce results or products meeting predetermined specifications, as required by the Federal FD&C Act and cGMP. Validation is an excellent tool to understand and maximize value from your business processes. Validation is also a compliance issue; the FDA requires ...
Manufactured by:CANDOR Bioscience GmbH based inWangen, GERMANY
Commercial kit-production for human- and veterinary diagnostics, for food diagnostics and more and more for environmental analytics and research assays are subject to high regulatory requirements. Assays have to be optimized in consideration of their reliability, limit of detection and robustness against matrix effects and interferences. The stability of the kit-components is very important as a ...
by:Stress Engineering Services, Inc based inHouston, TEXAS (USA)
At Stress Engineering Services, we provide fully connected product, device, and equipment development solutions. The range of application is very broad and includes healthcare products and facility-related initiatives, pharmaceutical drug delivery products, and supply chain tracking. We offer end-to-end solutions including working with your supply chain. Our technical knowledge combined with ...
by:Xybion Corporation based inPrinceton, NEW JERSEY (USA)
Computer Systems Validation, Testing, And Compliance Services: If you are seeking computer system validation experts, look no further. Xybion has demonstrated expertise validating computer programs for all types of regulated businesses in the energy, transportation, financial services, and life sciences (including FDA-regulated businesses such as pharmaceutical and medical device manufacturers, ...
Manufactured by:Minaris Regenerative Medicine, LLC based inAllendale, NEW JERSEY (USA)
Minaris Regenerative Medicine’s manufacturing development services help you to design efficient and robust manufacturing processes for your cell and gene therapy. Keeping the ultimate goal of commercial supply in mind, we help you think beyond your current manufacturing needs to create approaches that improve the commercial viability of your products. We keep in mind four key elements of ...
Manufactured by:Waldemar Link GmbH & Co. KG based inGermany, GERMANY
This not only applies to the production facilities in Norderstedt but equally to the Berlin-based investment foundry VACUCAST and the company's own specialist development enterprise, DERU. LINK is continually working on innovations in all areas - from new coatings through to optimized instruments in order to satisfy the advances in day-to-day ...