Vision Software

Foss NIRSystems, Inc., a unit of Foss A/S of Denmark, is the world's leading supplier of scanning Near Infrared products and services for the pharmaceutical and chemical markets. Our extensive application knowledge, global distribution, and support network ensures efficient method development and routine implementation for years to come. Our software is fully compliant to 21 CFR, Part 11 for the benefit of our pharmaceutical customers

Advant

Layered on to and designed to be integrated into the hardware packages is the expertise of ABB’s Knowledge solutions. Continually evolving to meet the current and emerging standards important to the Pharmaceutical business, such as Electronic Batch Records based on 21 CFR part 11, or Batch Control Systems compatible with ISA S88.01 standards, ABB prides itself in providing the customer the optimized package solution for his current and future needs

Rapid Pharm

Automsoft's RAPID-Pharma is the first Plant Information Management System to offer out of the box compliance with the specification, which will enable companies to keep complete audit trails of their electronic records in a highly secure system.

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.

CIWOS

CSEngineering AG has software called CIWOS that is 21 CFR Part 11 compliant.

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

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

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.

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.

iFix iBatch

Intellution, Inc., developer of industrial automation software, has been delivering the industry's most advanced HMI/SCADA, batch, softlogic, and internet solutions. Working in unison with key biotech and pharmaceutical representatives, FDA regulatory personnel, original equipment manufacturers and systems integrators, Intellution is developing the tools that will empower all FDA-regulated companies to come into compliance.

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.

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.

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

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.

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

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

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.

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

Agile Anywhere

Agile Software Corporation provides collaborative manufacturing commerce solutions for the e-supply chain. The Agile Anywhere™ product suite allows supply chain partners to leverage the Internet and form virtual manufacturing networks for design control, product introduction, manufacture, and change. Agile Buyer™ enables Internet-based demand aggregation, RFQ processes, and online procurement of direct (production) materials. Agile Anywhere is 21 CFR Part 11 compliant for electronic records and electronic signatures with a proven validation methodology.

Compliance Builder

We have developed Compliance Builder: The Turnkey Part 11 Compliance Solution, which has been designed for FDA services. Regulated environments to bring their existing or legacy data collection systems into 21 CFR § 11 compliance. This turnkey solution integrates seamlessly and quickly into existing topology and is delivered with all required software,