Software
Process Control Software
Please find below our listing of possible software solutions for the Pharmaceutical, Medical Device or Life Sciences Industry wishing to comply with the FDA, TGA, MHRA regulations.
Process Control Automation Software:
| Vendor | Claim | Website |
| MasterControl™ | MasterControl™ integrated QUALITY and COMPLIANCE management software systems for FDA and ISO regulated industries. Integrated software systems include CAPA, Document Control, Training Management / Tracking, Change Control, Audits, Complaints Handling, eProcess Automation, Sarbanes-Oxley (SOX), etc. | www.mastercontrol.com |
| PFS Suite | PFS-Suite is intended to facilitate the engineering activities involved in automation software. | www.specsoft-pfs.com |
| CIMScan | The FDA has now started aggressive enforcement of 21 CFR Part 11, which the regulation regarding electronic records and electronic signatures. CIMScan now contains all the necessary functions and capabilities to insure compliance. | www.cimtechniques.com |
| CIWOS | CSEngineering AG has software called CIWOS that is 21 CFR Part 11 compliant. | www.ciwos.com |
| DeltaV | The DeltaV™ digital automation system delivers integrated batch automation that’s easy to engineer, easy to use, and easy to validate. It’s built to S88 standards and fully addresses the FDA’s 21 CFR Part 11 requirements with integrated recipe and campaign management, batch history, automatic version and change management | www.easydeltav.com |
| Acceliant | Enmed's Acceliant™ Clinical Trial Solution is a comprehensive, flexible, and integrated solution designed to improve the speed and efficiency of clinical development. The Acceliant Clinical Trial Solution has been designed to exceed current industry regulations for clinical trial software, including the FDA 21 CFR part 11 | www.enmed.com |
| DeltaV | Significant batch enhancements in the Version 5 release include support for both running batches in campaigns and enhancements focused to support FDA regulations in 21 CFR Part 11. New patented Configuration Audit Trail software controls, manages and tracks all changes to the DeltaV configuration database saving time, effort and improving accuracy of configuration management. This software supports electronic record keeping per 21 CFR Part 11. | www.frco.com |
| Genesis32 | ICONICS, a leader in the development of Web-enabled OPC-based industrial automation software for Microsoft® Windows® operating systems, announced that Version 6.1 of GENESIS32™ offers a wide variety of tools for complying with the FDA 21 CFR 11 regulations. It enables proper handling and recording of FDA-regulated electronic information, and applies "electronic signatures" such that the FDA considers them to be "equivalent" to that of handwritten signatures and documents. | www.iconics.com |
| Foxboro I/A Systems Wonderware Avantis Eurotherm | Invensys Pharmaceutical Solutions, a division of Invensys Production Management is a leading supplier of manufacturing control (Foxboro I/A Series System, Wonderware), manufacturing execution (Avantis) and environmental systems (Eurotherm) that meet and exceed the guidelines of 21 CFR part 11. Invensys Pharmaceutical Solutions has a dedicated group of pharmaceutical engineers and specialists focused on this industry, regulations, and new technology tools. Our unique solution includes a full range of products, automated tools, validation services (VTI), and procedures to help comply to 21 CFR part 11. We leverage our expertise to provide systems, tools, policies, and procedures for compliance. | www.foxboro.com |
| O.N.G. Automation are the official Rockwell Automation (Allen Bradley) and Foxboro I/A DCS Authorised integrator in Ireland, providing us direct access to the vast range of services and support which is available from both Companies. O.N.G. Automation has proven experience in the implementation of Control Systems from design stage through to final commissioning, In the Pharmaceutical, Biochemical, Food, Water and Electricity generation industries. We specialise in GAMP3 and 21 CFR part 11 compliant systems. | www.ongautomation.com | |
| APSS-200 Automated Parenteral Sampling System | 21 CFR Part 11 Compliant; Secure System Audit Trails; Encrypted Data; Ease of Validation; Unique User Names And Passwords; Software Validation Notebook | www.prmeasuring.com |
| MAP 80 Prisymedica | Prisymedica is the only label design and production software that exceeds FDA standards for compliance, as demanded by the Pharmaceutical, Clinical Trials and medical device industries. Prisymedica, the latest product from MAP80, has been specifically introduced to meet the requirements of the FDA 21 CFR Part 11 rules regarding Electronic Records and Electronic Signatures. | www.map80.co.uk |
| Many Products | Process Analysis & Automation Ltd provides state-of-the-art automation and measurement technology to the pharmaceutical and chemical industries. Custom software and application services. Many products listed as 21 CFR part 11 compliant | www.paa.co.uk |
| RSView32 | Rockwell Automation has announced that its flagship HMI products, RSView32™ and RSView32 Active Display System™, fully support the development of projects and systems that comply with FDA (Food and Drug Administration) Title 21 - Code of Federal Regulations - Part 11 (21 CFR Part | www.suppor.sofware.rockwell.com |
| InBatch | InBatch has been designed to meet the requirements of even the most regulated industries. InBatch is100% compliant with the United States Food and Drug Administration (FDA) final ruling on Electronic Records and Electronic Signatures referred to as 21CFR Part 11. | www.wonderware.com |
| ICPExpert | Varian, Inc. understands the importance of providing software tools for its customers that facilitate their compliance with US FDA regulations. Varian’s instrument control software provides its customers with a robust, reliable platform that continues to evolve to meet their changing requirements. In continuing with this commitment, it is Varian’s intention to provide software for selected Optical Spectroscopy Instruments to help its customers meet the requirements of the FDA Electronic Records and Electronic Signatures Rule | www.varianinc.com |
The above table lists all the Software identified by PharmOut Information Technology.
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