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SPECORD® PLUS – FDA Compliance Guaranteed!

Analytik Jena GmbH+Co. KG
18 Jan 2016
Lois Manton-O'Byrne, PhD
Executive Editor

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The FDA conforming WinASPECT® PLUS software for the SPECORD® PLUS series of Analytik Jena offers the ideal tool for efficient analysis in all fields, from R&D to production, from quality control to routine analysis.

Industries like pharmacy, biotechnology and medicine are subject to strict requirements of regulatory authorities. The Food and Drug Administration (FDA) is the supreme authority for consumer protection in the USA. It checks and monitors the manufacturing, storage and distribution of foods, cosmetics and drugs. Their aim is to guarantee safety, digestibility and effectiveness of products. The FDA establishes the requirements for recording the electronic signatures of data, which are defined in the 21 CFR (Code of Federal Regulations) Part 11.

With regard to verifiability, forgery protection and traceability, the SPECORD® PLUS in combination with the WinASPECT® PLUS FDA 21 CFR Part 11 software offers user management with the possibility to define different users with individual access rights. Passwords with a limited period of validity guarantee absolute data security. Furthermore, an Audit Trail records all accesses and actions during the analysis transparently so that every result can be traced back. By the electronic signature the files will be encrypted, providing a protection against further modifications. All processes are presented in easily comprehensible terms and with a clear layout.

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Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Food and Beverage AnalyzersFood and Beverage Analyzers are commonly used to provide information about the chemical composition, structure and physical properties of food materials.Food and Beverage ProcessingFood and Beverage Processing involves the preparation of food products for further analysis. Typical instrumentation includes blanchers, color sorters, cookers, grinders, and refrigeration. These are used to replicate the processes commonly used in the commercial preparation of food and beverages.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Software PlatformsSoftware platforms are useful for various stages of laboratory experiments from data collection to data storage and processing. For instance lab software is available for system control, data management, data analysis and qualification / validation.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Contamination PreventionContamination prevention aims to control and minimize the risk of contamination during experiments. Biological safety cabinets and sterilization equipment are examples of technologies used to prevent contamination.Routine QuantitationFood SafetyFood safety describes the prevention of food-borne illnesses. Contamination with a variety of pathogens can be prevented with adequate temperature control, hygiene and labeling. Food samples can be tested using GC/MS, HPLC, SPE, and qPCR to ensure their adherence to regulations.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.Food TestingFood testing refers to a variety experiments including PCR, mass spectrometry, processing, QuEChERS, analyzing and Kjeldahl.CosmeticsPharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.

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