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product regulation software

  • Change Control Software Systems

    Change Control Software Systems to Automate Paper-based Change Control / Change Management Processes in Regulated Environments and Assures Enhancement in Productivity. In FDA-regulated and ISO-certified environments, companies are expected to establish procedures for effective change control software systems in order to ensure product quality and ...

    By MasterControl, Inc based in Salt Lake City, UTAH (USA).

  • Classification Programs Software

    Classification according to US GHS ('Hazard Communication GHS Final Rule'). Classification according to Canadian GHS ('Hazardous Products Regulation (HPR)'). Classification according to CLP ('EU-GHS', Regulation 1272/2008/EC in the latest valid version). Classification according to UN GHS ('Globally Harmonized System of Classification and ...

    By DR-Software, Inc. based in Sollenau, AUSTRIA.

  • PAS-X

    With PAS-X, Werum offers a mature standard software product for the highly regulated and batch-oriented process industries. The PAS-X MES provides out-of-the-box maximum standard functionality for all applications in the pharmaceutical and biopharmaceutical sector. Companies using PAS-X benefit from lean production and operational excellence.

    By Werum IT Solutions based in Lüneburg, GERMANY. from The Manufacturing IT Platform for Pharma & Biotech Software line

  • Version VOC & TOC - Module for Management of Volatile Organic Compounds

    The software for the VOC calculation refers to Directive 2004/42 and updates, which requires that the Hazard Label of the products subject to this regulation must necessarily show, in a clear and readable way, the following information: The type of product in accordance with the definitions contained in Annex I of the Directive; The VOC limit ...

    By Selerant srl based in Cassina de pecchi, ITALY. from SDS Compliance Software: HazEX Software line

  • Audit Management Software Systems

    Audit Management Software Systems for Life Science and Other Regulated Companies. MasterControl's Automated Audit Management System can dramatically reduce the time and effort involved in preparing for and conducting audits. Almost all types of businesses undergo audit, but it is particularly critical for Life Science and other regulated ...

    By MasterControl, Inc based in Salt Lake City, UTAH (USA).

  • 3E - Insight for Chemicals

    How accurate and up to date is the regulatory data behind your product decisions? Regulations have increased fivefold since the inception of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and they are far from harmonized. From R&D through production, market launch and disposal the sheer volume of information ...

    By Verisk 3E based in Carlsbad, CALIFORNIA (USA). from Regulatory Reference Software line

  • EPY - Modular, Integrated Software Suite

    EPY is a modular, integrated software suite developed specifically to help European chemical companies comply with the regulations governing chemical products. In addition to full compliance with the European Regulation, the possibility of creating SDS and hazard labels has now been added for the Chinese and the US markets. The continous ...

    By Telematic S.r.l. based in Cinisello Balsamo, ITALY.

  • Tremcards And ADR 2009

    NCEC supplied its Cefic Tremcards product to help companies transporting hazardous products to meet the requirements of ADR regulation 5.4.3. This defines the instructions in writing that must be carried by the driver, to provide advice in the event of an accident during their journey.

    By NCEC (National Chemical Emergency Centre) based in Didcot, UNITED KINGDOM.

  • Pims - Experience and Benchmarking

    Streamline data collection, Access data from ongoing and completed projects, Perform benchmark analyses, Compare data between projects, Update estimate manuals and key figures efficiently, Choose between numerous reporting options, Find experience data using a comprehensive search engine, Utilize data import capabilities.

    By Omega AS based in Ølensvåg, NORWAY.

  • GaBi DfX - Direct BOM Import into LCA Software

    GaBi DfX is the professional software for compliance and sustainable product development with a view to the end of life phase. If you want to consider different regulations during product design, such as the EU Directives for end-of-life vehicles, for waste electrical and electronic equipment, energy using products or for the restriction of ...

    By thinkstep - A Sphera Company based in Leinfelden-Echterdingen, GERMANY.

  • LabX Laboratory Software

    Work on your laboratory instrument with full step-by-step user guidance through your SOP, your data and results are stored securely as part of your procedure, and labels and reports are printed automatically – this is the reality of LabX!

    By Mettler - Toledo Int. Inc based in Greifensee, SWITZERLAND. from Laboratory Weighing Software Software line

  • WLabel - Automatic Regulatory Label Calculation Software

    “WLabel” software was created to implement Directive 1999/45/CE pertaining to “all preparations” and its subsequent adaptations, including Directive 2006/8/CE. WLabel can determine the classification and labelling for all products on the market in the chemical industry. It also manages any related problems that arise in ...

    By InfoDyne SAS based in Bourron-Marlotte, FRANCE.

  • Sending Data to ISSWizard Module

    The ISSWizard module is aimed at companies responsible for placing dangerous mixtures on the market and who have to communicate the chemical composition of those mixtures to the Italian national institute of health (Istituto Superiore di Sanità) for the Dangerous Preparations Archive, established by D.Lgs 65/03. ISSWizard simplifies the ...

    By Selerant srl based in Cassina de pecchi, ITALY. from SDS Compliance Software: HazEX Software line

  • Sparta - Integrated Complaint Management Software

    Now more than ever, leading companies are striving to centralize their complaint handling processes to reduce risk, comply with best practices, and streamline operations. Sparta's complaint handing solutions can be used for documenting, managing, and following up on customer inquiries and complaints and tracking subsequent actions. The system ...

    By Sparta Systems, Inc. based in Hamilton, NEW JERSEY (USA). from Medical Device Software line

  • Global Product Regulatory Software (GPRS)

    GPRS solutions are mission critical for enterprises as they scale to new markets and face a variety of regulatory hurdles. Assent’s GPRS is used by Fortune 1000 firms to meet their regulatory requirements and ensure products continue to ship without issue.

    By Assent Compliance Inc. based in New York, NEW YORK (USA).

  • Plant Accounting and Settlement Systems (PASS )

    With our PASS software (Plant Accounting and Settlement System), VTU offers a multifunctional software system that can be configured to exactly reproduce the regulations and performance guarantees of the contract. Production capacity and fuel efficiency of power and cogeneration plants are highly dependent on operating conditions. Thus, commercial ...

    By VTU Energy GmbH based in Raaba-Grambach, GERMANY.

  • CMC SmartCEMS - Version SCAEM - Alternative Emission Monitor

    The SmartCEMS Alternative Emission Monitor is a component of a predictive emission monitoring system (PEMS) that provides continuous stack gas analysis for pollutants and diluents. Sources monitoring using this product are typically not regulated under U.S. EPA 40 CFR Part 60 and/or U.S. EPA 40 CFR Part 75. The Alternative Emission Monitor product ...

    By CMC Solutions, LLC based in Farmington Hills, MICHIGAN (USA).

  • COLLINE - Regulatory and Strategic Collateral Management Software

    Mandated regulations such as Dodd-Frank and EMIR (European Markets Infrastructure Regulation), supervisory frameworks – BASEL III, BCBS (Basel Committee on Banking Supervision) – IOSCO (International Organisation of Securities Commissions) have changed the landscape of collateral management. Collateral Management Solutions from Lombard ...

    By Lombard Risk based in London, UNITED KINGDOM. from Collateral Management Software line

  • CMC SmartCEMS - Version SCCAM - Compliance Assurance Monitor

    The SmartCEMS Compliance Assurance Monitor is a component of a predictive emission monitoring system (PEMS) that provides continuous stack gas analysis for pollutants and diluents. Sources monitoring using this product are typically not regulated under U.S. EPA 40 CFR Part 60 and/or U.S. EPA 40 CFR Part 75. The Compliance Assurance Monitor product ...

    By CMC Solutions, LLC based in Farmington Hills, MICHIGAN (USA).

  • Quality Management Software Systems

    Replacing Paper-based Quality Management Systems with Automated Quality Management Software Systems Dramatically Improves a Company's Ability to Comply with FDA Regulations and ISO Quality Standards

    By MasterControl, Inc based in Salt Lake City, UTAH (USA).

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