Validation is of paramount importance in the pharmaceutical, biotech and medical devices industries. The person creates what he or she thinks is the best work, frames it & places it in the gallery to be shown. But, it should fulfill regulatory obligations and comply with internal quality requirements. The degree of validation performed must be based on code complexity, consumer base and carefully assessed risk factors. Regulatory agencies, such as the US FDA have long established validation as a core requirement of quality assurance for medical device manufacturers. Still, many companies fail to develop an adequate validation program which can prove to be costly, if discovered by an inspector. Validation is broadly applied across the organization to ensure that products, equipment, processes, software & systems operate, as designed and intended. Successful validation practices bring together engineering, manufacturing, regulatory compliance & quality assurance to develop test solutions that are unique to each application.
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Address: 988 San Antonio Road, Palo Alto, California 94303, USA
www.validationsystems.com |
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Phone: +1-(650)-856.4874
Validation Systems Inc. is a full service validation contractor and laboratory service provider. We offer services to pharmaceutical, biotechnology, and medical device industries. We provide contract
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Address: 11590 West Bernardo Court, Suite 245, San Diego, California 92127, USA
www.validation.org |
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Phone: +1-(800)-930.9222
Validation Technologies, Inc., provides validation & commissioning services to the pharmaceutical, biotechnology and medical device industries. We are an ISO 9001:2000 certified company. We offer a fu
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Address: 9885 Mesa Rim Road, Suite 101, San Diego, California 92121, USA
https://moleculardepot.com |
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Phone: +1-(858)-900-3210
Molecular Depot LLC specialize in the development of research tools and biochemicals. Our products include specialty bacterial culture media, antibodies & antigens, enzymes & proteins, chemical compou
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Address: 11757 Central Parkway, Jacksonville, Florida 32224, USA
www.adpen.com |
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Phone: +1-(904)-645-9169
Adpen Laboratories Inc. provides advanced analytical services in the pharmaceutical, biotech, cosmetics, nutraceutical, food safety, food & nutritional products, agrochemical and animal health industr
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Address: 6701 Democracy Boulevard, Suite 300, Bethesda, Maryland 20817, USA
www.amethysttech.com |
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Phone: +1-(301)-571-9342
Amethyst Technologies, LLC has services to offer all entities that manufacture parenterals or pharmaceuticals, perform aseptic filling, manufacture medical devices, treat patients, build laboratories,
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Address: 4539 Metropolitan Court, Ste. 221, Frederick, Maryland 21704, USA
www.meridianbiogroup.com |
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Phone: +1-(301)-360.9771
Meridian BioGroup LLC is a validation and compliance contract service provider to the biotechnology & pharmaceutical industries. We offer services that include validation of utility systems, process e
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Address: 676 Wagon Ford Rd., Pink Hill, North Carolina 28572, USA
www.concentricbioservices.com |
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Phone: +1-(252)-233-2233
Concentric Inc. is a provider of consulting and validation services in FDA-regulated environments. We offer a wide range of technical services in the areas of equipment, process & computer related sys
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Address: 808 Salem Wood Drive, Suite 103, Raleigh, North Carolina 27615-3345, USA
www.ofnisystems.com |
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Phone: +1-(919)-844-2494
Ofni Systems Inc. is a computer service and software company. We help companies address the opportunities present in 21 CFR Part 11, electronic records and electronic signatures. We offer proven softw
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Address: 2880 Bergey Road, Suite AA, Hatfield, Pennsylvania 19440, USA
www.pharmacadence.net |
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Phone: +1-(215)-853-2627
Pharmacadence Analytical Services, LLC provides quantitative bioanalytical results for the early stages of drug discovery and lead optimization. We specialize in rapid and reliable turnaround for disc
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Address: 4181 Calle Tesoro, Camarillo, California 93012, USA
www.meissner.com |
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Phone: +001-(805)-388-9911
Meissner Filtration Products, Inc. manufactures microfilters, microfiber filters, biocontainer assemblies, 316L electropolished stainless steel filter housings and Accuflux® automated integrity te
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Address: 2746 Loker Avenue West, Carlsbad, California 92008, USA
www.mobio.com |
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Phone: +001-(800)-606-6246
Mo Bio Laboratories, Inc manufactures and supplies tools for researchers in molecular biology. We offer kits for DNA clean-up & gel extraction, plasmid DNA isolation, soil DNA isolation, microbial DNA
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Address: 1601 S. De Anza Blvd., Suite 212, Cupertino, California 95014, USA
www.bioimagene.com |
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Phone: +001-(408)-207-4200
BioImagene, Inc. provides scalable digital pathology solutions for clinical diagnostics and drug discovery aplications. We develop & deliver fully integrated hardware and software systems to acquire,
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Address: 1906 Grove Rd., El Cajon, California 92020, USA
www.novabiotech.com |
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Phone: +001-(619)-579-0077
Nova Biotech provides service and tech support for Uv/Vis spectrophotometers, spectrofluorometers, microplate readers, FTIR, PCR thermo cyclers, HPLC, FPLC, GC and temperature control instrumentation.
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Address: 1594 Myrtle Avenue, Eureka, California 95501, USA
www.smatrix.com |
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Phone: +001-(707)-441-0407
S-Matrix Corp. develops advanced software that automates R&D experimental work according to quality-by-design principles and methods. Our Fusion AE software product modules are an automated design, an
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Address: 46501 Landing Parkway, Fremont, California 94538, USA
www.golighthouse.com |
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Phone: +001-(510)-438-0500
Lighthouse Worldwide Solutions is a supplier of real time contamination monitoring systems and airborne particle counters. We offer a complete line of contamination monitoring solutions that include a
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Address: 15339 Barranca Pkwy., Irvine, California 92618, USA
www.wavesense.net |
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Phone: +001-(949)-341-1980
WaveSense, Inc develops & manufactures analytical nanotechnologies for use in cellular and molecular assay markets. We offer Episep™ hybridization slide with non-sterile, 8 ml capacity & removab
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Address: 38 Miller Avenue, PMB 170, Mill Valley, California 09494, USA
www.stark-smo.com |
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Phone: +001-(415)-888-3700
Stark-Smo is a site management organization. We specialize in compassionate use studies, humanitarian use devices, humanitarian device exemptions, early access programs, orphan drugs, research program
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Address: 321 E. Evelyn Ave, 3rd Fl., Mountain View, California 94041-1530, USA
www.pharsight.com |
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Phone: +001-(650)-314-3800
Pharsight Corporation. provides software products & scientific consulting services for pharmaceutical and biotechnology companies. We offer PK/PD modeling, pharmacokinetics, R&D management, clinical m
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Address: 395 Page Mill Rd., Palo Alto, California 94303-0870, USA
www.agilent.com/chem |
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Phone: +001-(650)-752-5000
Agilent Technologies, Inc. manufactures & supplies analytical instruments. We also offer software and services to the life science & chemical analysis markets. Our products range from electrophoresis,
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Address: 6260-B Marindustry Dr., San Diego, California 92121, USA
www.geoscienceltd.com |
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Phone: +001-(858)-453-5483
Geoscience Ltd. is a service and R&D company specializing in heat transfer, fluid flow, mass transfer, micro meteorology, biophysics, the measurement of thermal, mechanical & fluid properties, enginee
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