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Company

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ABB

Advant

www.abb.com

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.



Agile Software Corporation

Agile Anywhere™

www.agilesoft.com

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.



Agilent Technologies, Inc.

ChemStation Plus

www.chem.agilent.com

The system enables users to comply with audit and approval requirements such as 21 CFR Part 11.



Aitken Scientific Ltd.

A-S Login

http://www.aitken-sci.co.uk/

A-S Login for Electronic Signature Compliance is a software product which provides complete 21 CFR Part 11 compliant user login functions, and a comprehensive administrator console



Alchemedia Technologies, Inc.

Mirage

http://www.alchemedia.com

DALLAS, TEXAS — January 9, 2002 — Alchemedia Technologies, Inc., a leading provider of Enterprise Digital Rights Management (EDRM) software, today announced the availability of Mirage Enterprise for pharmaceuticals, providing critical data currency and confidentiality functions for companies governed by FDA regulation 21 CFR Part 11. Electronic documents, the subject of Part 11, are easy to copy and distribute, but copies are difficult to manage. The resulting rogue documents cannot be audited or updated, and therefore are violations to the FDA regulation. By controlling the saving, copying, forwarding and printing of documents, Mirage enables pharmaceutical companies, for the first time, to cut off rogue documents at the source, greatly reducing the scope of their exposure under Part 11.




American MSI Corp.

CelltrackPro™

www.americanmsi.com

Celltrack PRO™ is an enterprise solution for manufacturers of medical devices that need to record, maintain, archive, retrieve, and transmit relevant manufacturing data, in compliance with the FDA's 21 CFR Part 11 regulation.... With Celltrack PRO™ you can record, maintain, archive, retrieve, and transmit relevant manufacturing data, including batch detail and downstream processing, equipment settings and measurements, as well as who changed what, when, where and even why. A closed data chain with high-level access control, record validity checks and data encryption guarantee tamper-free data integrity from the point of data collection through reporting and archiving. Celltrack PRO™ can generate accurate and complete copies of records in both print and electronic form (PDF) for inspection and review.



Amersham Biosciences

UNICORN Control System, version 4.0

http://bioprocess.apbiotech.com/

UNICORN Control System, version 4.0, is fully compliant with 21 CFR Part 11. It is currently in use in many biopharmaceutical production processes approved by the FDA.



Analex

ESign

http://www.analex.com/html/med_erecords_esignatures.html

Aside from merely understanding the 21 CFR Part 11 regulation, Analex has successfully developed Electronic Records and Electronic Signatures components, known as ESign™, for its own in-house software. Analex has also been invited to give presentations regarding Part 11 at medical device and pharmaceutical conferences. Using our experience and expertise, Analex can help your company become compliant as well.



Ankersmid

TOC Talk, Version 3.5

http://www.ankersmid.com/Holland/index holland.htm

TOC Talk, Version 3.5 is designed to handle and manage TOC data and metadata within the TOC Talk application in compliance with 21 CFR Part 11 protocols



Applied Biosystems

Analyst™

SQL LIMS

www.appliedbiosystems.com

Analyst™ software unites power and ease to set a new standard in Windows NT® platform-based data processing. Automated software routines rapidly and completely optimize the instrument for quantitative analysis. After data acquisition, the Quantitation Wizard quickly guides the creation of new quantitation methods. Queries, metric plots, configurable results table, and slide show mode provide fast and thorough data review. For regulated laboratories, you can easily achieve GLP compliance including the recommendations of 21 CFR Part 11 with comprehensive Security and centralized Audit Trail Manager. Analyst software provides flexible data acquisition, fast and easy data. SQL*LIMS® software is a complete laboratory information management system (LIMS) that gives you control over sample tracking, laboratory processes and workflow, data access and storage, and regulatory compliance. Supports your laboratory’s compliance with the FDA’s 21 CFR 11 Rule with dynamic security and regulatory compliance features



Applied Statistics Inc.

Applied Stats v4.4 SPC

www.appliedstatistics.com/press/21CFR.htm

ASI offers the most comprehensive tools available today to address the security and data collection requirements posed by 21 CFR Part 11. Applied Stats v4.4 SPC software package incorporates a robust set of security options and policies that allow our customers to comply with these rigorous requirements and collect data with confidence.



ARC Systems, Inc.

TrendReader Standard Data Logger

http://www.acrsystems.com/

ACR Systems Inc. has introduced a new update version of the TrendReader Standard Data Logger Software, version 1.2 beta, which includes data validation that permits our software and hardware to conform to the FDA’s 21 CFR Part 11 regulations. This assures users that the data viewed on either the PC or printed form is authentic by providing a data file sign-off mechanism, a CRC check (Cyclic Redundancy Check) for data integrity, and an overall data validation pass/fail statement with sign-off right on the graph.




Aspen Tech

InfoPlus.21 and Batch.21; Aspen Alarm and Event;Aspen eBRS

http://www.aspentech.com/

Aspen Technology Inc. announced new software solutions that provide pharmaceutical and other regulated process manufacturers with a broad range of solutions to comply with Title 21 of the Code of Federal Regulations.



AssurX

CATSWeb

www.assurx.com

Are you concerned about Title 21 CFR Part 11 FDA regulations governing electronic records and electronic signatures? Don't be. The FDA edition of CATSWeb is fully compliant.



Automsoft International LTD

Rapid-Pharma

www.automsoft.com

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.



AVATAR Consulting

LABTrack

www.labtrack.com


LABTrack incorporates a function called Electronic Signature that was defined by the United States Food & Drug Administration (21 CFR Part 11). Electronic Signature is a mechanism to accurately identify the user of the software at the time data is saved. It can do so using either controlled passwords or biometric devices like fingerprint readers. LABTrack supports both.



Beamex

QM6, Quality Manager Calibration Software

http://www.beamex.com/products/qm6_004.htm

The Log Book option now also includes an Electronic Signature feature. If the Electronic Signature is enabled, QM6 prompts for user id and password when a calibration is saved or approved.



Beckman Coulter

Pinnacle

www.beckmancoulter.com/pinnaclepart11


Pinnacle is the first CDS to be designed from the ground up to meet Part 11 requirements. Its Oracle* relational database and built-in security system ensure that no data can be deleted and that modifications are only performed by authorized personnel. Not only do Pinnacle's electronic records meet Part 11 requirements, system administrators can also minimize the compliance burden by determining when electronic signatures and modification reasons are required.



BioLog

MicroLog and OmniLog Systems

http://www.biolog.com

The MicroLog and OmniLog systems are designed to exist within a 21CFR Part 11 environment and provide the basic functionality to support our customer's compliance efforts. Biolog provides all of the necessary software features, validation packages, and optional assistance to support full (including 21 CFR Part 11) compliance.




BioMedion

INDexxis™

http://www.biomedion.com/en/indexxis.html

INDexxis™ is designed to manage data in accordance with predicate rules (GxP) and the new regulations on electronic records and electronic signatures, especially FDA 21CFRpart11.



Blaze Systems Corp.

BlazeLIMS Enterprise Plus

www.blazesystems.com

BlazeLIMS Enterprise Plus provides flexible sample registration functions, including ad hoc logs, batch/requests, QC batch, and stability studies, with manual or automated results entry in a 21 CFR Part 11-compliant environment.



Blue Mountain Software

Calibration Manager®

www.coolblue.com


Our flagship product, Calibration Manager® software, is among the world's leading calibration management database programs. Calibration Manager automatically calculates due dates, tracks histories and prints reports of calibration schedules. It also tracks preventive maintenance. Flexible data retrieval and reporting capabilities permit customization according to your exact needs. Password protection, audit trail and electronic signature features facilitate your validation process and ensure effective FDA record-keeping compliance. The electronic signature functionality was specifically designed to meet FDA 21CFR Part 11 requirements.



Brendan Scientific

StatLIA

http://www.brendan.com/

Brendan develops laboratory software to provide one complete standardized program for all immunoassay testing technologies. For automating workflow, the software is designed for easy interfacing and networking to any LIM system, instrument and PC. And all raw, computed and statistically analyzed data are organized, secured, and easily accessible. We believe that the less time spent processing, computing, validating, organizing, and troubleshooting data, the more time laboratories can spend using the data generated. 21 CFR Part 11 Compliant.
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