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


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Company

Product(s)

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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.



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.



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.



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.



ChemScope


eGMP

www.egmp.com

eGMP is compliant with FDA regulations, including 21 CFR Part 11. And all through a single web browser!



Clinsoft

Clintrial Connect ™

Clintrial ™

Clintrace ™

Integrated Review ™

Jreview ™

www.clinsoft.com

Clinsoft Corporation is the world's largest provider of clinical research systems. Market leadership and innovative technology position Clintrial™ as the industry-standard information platform for biopharmaceutical and related industries. Clinsoft's information platform enables companies to focus development resources on product "winners" sooner and has brought more pharmaceutical products to market than any other software platform.



Communication Intelligence Corporation (CIC)

Sign IT

http://www.penop.com

Provide electronic signature software. Communication Intelligence Corporation (CIC), provides input, security and electronic signature offerings to Enterprises, OEMs, integrators, Asps, Strategic Partners and End Users.

And by making possible the legally secure electronic signing of documents anywhere at any time, CIC leadership is a prime mover of businesses toward a paperless world.




Computer Compliance, Inc.

EFLEXION

http://www.e-flexion.com

A revolutionary, powerful monitoring tool, EFLEXION fully automates the tasks of process data management. E-Flexion automates every step, every task, in quality information management. Manual data handling is eliminated, saving considerable time and freeing people for higher level, strategic use. Human time can be spent interpreting results and taking action. Comprehensive in operation, analytical abilities, and features, E-Flexion gathers, analyzes, and delivers all the information you need. Data is collected and analyzed around the clock from any piece of equipment, for any desired analysis. Everything from production data to run comments is stored in a complete record.

Built for compliance from the ground up, E-Flexion meets strict federal regulations for electronic record keeping, including requirements of FDA 21CFR Part 11. An internal audit log -- with assigned access privileges -- tracks any changes made to any records in the database repository. Repository data cannot be deleted. Data transfer from collection to repository is error-free and fault-tolerant.



Creon

Q-DIS/R

www.creon.com

The extended use of computer technology and the increasing automation in the field of modern chemical analytic, produces large quantities of analytical data.

In consideration of:

• the diversity of data sources

• GLP and GMP guidelines

• governmental requirements (FDA 21, CFR Part 11)

• company objectives



Cyber-SIGN Inc.

Cyber-SIGN

www.cybersign.com

Cyber-SIGN and Biometric Dynamic Signature Verification

Cyber-SIGN®, we are a leader in the area of on-line enterprise user authentication utilizing biometric dynamic signature verification technology. With Cyber-SIGN, using handwritten signatures, on-line identity is securely authenticated and a trusted electronic signature is created. Our technology is a simple and natural biometric system that increases data security and enables trusted document authorization. We analyze the shape, speed, stroke order, off-tablet motion, pen pressure and timing information captured during the act of signing. The captured values are unique to an individual and virtually impossible to duplicate.



Dionex Corporation

Chromeleon

www.dionex.com

New Electronic Signature and Signoff feature provides electronic signatures in conformance to FDA's 21 CFR Part 11 rules. Unique signoff levels allow users to submit, review, and approve electronic records from CHROMELEON efficiently and completely.



Document Control Systems, Inc.

MASTERControl

http://www.mastercontrol.com/


MASTERControl regulates secure access to documents and other electronic files created in any software application. MASTERControl FDA Edition was written to address stringent security requirements for FDA companies. This includes both the enhanced features needed to comply with these standards and assistance with the on-site validation process.



Doxis

SCCM


www.doxis.com


Doxis and 21 CFR Part 11 Compliance

Allows you to keep process records (required by GMPs) securely and in strict compliance with 21 CFR Part 11

Has been designed to ensure record authenticity and integrity - features are carefully crafted to provide:

Strict control of user access, and of permitted user actions by role

Accurate and easy date retrieval for authorized users

Automatic audit trailing of data entries and user actions

Provides options for biometric (handwritten) and non-biometric electronic signatures

Automatically stamps all data entries and signatures with date, time, and user identification

Binds all e-signatures to their records, so they cannot be excised or copied



Enmed

Acceliant™

http://www.enmed.com/


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's 21 CFR Part 11.



Entrust Technologies

Entrust/PKI™

http://www.entrust.com

Digital Certificate technology can be used to ensure access control, authentication and non-repudiation of digital transmissions, providing a secure and reliable means of communicating and affecting transactions over public and private networks. The Entrust family of products offers a complete security infrastructure that is supported across multiple platforms and applications. Entrust provides a complete digital certificate-based solution for digital signature and encryption, that will meet the requirements of the FDA for organizations that want to use electronic records and electronic signatures.




eOriginal Inc.

eOriginal™

www.eoriginal.com

The eOriginal™ system meets or exceeds all of the FDA requirements for electronic filings



Fisher-Rosemont

DeltaV

http://www.frco.com/

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.
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