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.

Datastream 7i

Datastream Systems, Inc. Asset Performance Management software, including more than Datastream’s solutions combine asset management functionality with advanced analytics for optimizing enterprise asset performance. Maintain and manage capital assets such as manufacturing equipment, vehicle fleets and buildings and create analyses and forecasts. Datastream 7iTM, Internet, web services architecture with broad enterprise asset management functionality, integrated procurement, advanced analytics and multi-site capability.

LiveAudit

DataMirror provides real-time data integration software that helps companies ensure cost-effective compliance with FDA Regulation 21-CFR Part 11. LiveAudit™ for DataMirror Transformation Server enables FDA-regulated companies to create real-time audit trails that preserve historical information

MicroMain XM

MicroMain XM™ gives you the tools you need to streamline maintenance operations, maximize productivity and reduce costs. This asset-based computerized maintenance management system (CMMS). Automate work orders, schedule preventive maintenance tasks and completely track assets, comprehensive reports.

In-Sight

Cognex Corporation, the world's leading supplier of machine vision systems, announced that its In-Sight™ family of network able vision sensors are compliant with the U.S. Food and Drug Administration's 21 CFR Part 11 regulations. Cognex Corporation designs, develops, manufactures, and markets machine vision systems, or computers that can "see."

COMPU4

The Compu 4 Automated Control System is specifically designed to meet the needs for all aspects of batch processing – including batch recipe creation and control, data acquisition, batch reporting, and trending. The Compu 4 is designed to meet 21 CFR Part 11 requirements. The Compu 4 is built around your choice of Supervisory Control and Data Acquisition (SCADA) packages (Intellution iFIX , Wonderware InTouch and Rockwell Software RSView32).

CMX, Calibration Manager

CMX is calibration management software that assists in documenting, planning, analyzing and, finally, optimizing calibration work. CMX's scalable technology and user configuration allows you to integrate it easily into other systems for a one-of-kind calibration system that fits your specific needs completely.

Calibration Manager

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. The electronic signature functionality was designed to meet FDA 21CFR Part 11 requirements.

CATSWeb

CATSWeb is a flexible, comprehensive "all-in-one" solution designed to help firms automate a variety of business processes especially those in the quality and regulatory compliance areas.

Clintrial, Connect, Clintrial, Clintrace, Integrated Review, Review

Clinsoft Corporation is the world's largest provider of clinical research systems. 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.

TrialXS/EDC

TrialXS / EDC complies with FDA 21 CFR Part 11 regulation and conforms to GCP guidelines.

CRF Box wireless

KEY FEATURES OF CRF BOX WIRELESS™: Patient-generated data entry via a wireless or handheld device, Edit checks to diary data before entry into trial database, 2-way communication between clinical R&D stakeholders, Diary page amendments during the trial, Multiple languages and technology platforms in the same trial Flexible generation of reminders and alerts to patients, 21 CFR Part 11 compliance.

DataTrak EDC

CFR21;Part 11 Compliant. When you compare EDC product you'll find DATATRAK's Audit Trail to be the best of breed. DATATRAK EDC gives you an audit trail down to the data field. This also means that if the Investigator loses a communications connection, they do not lose data.

DocuStore Repository eNOW

Biotechnology research, discoveries and applications ultimately find their way to public use. Any entity that accepts, maintains or transmits electronic data must comply with a standardized Electronic Data Interchange (EDI) format.

iSuite

etrials offers iSuite, an innovative and powerful data entry system that allows investigators and site administrators to make immediate decisions based on having cleaner data -- faster. Our eCRF form is 21 CFR Part 11 compliant.

Xtrials

We offer a breakthrough, workgroup management technology that is native XML-based, fully 21 CFR Part 11 compliant, and able to be customized for individual company implementations. The XTrials TM Application Architecture is a fully-scalable clinical data management environment for EDC, Clinical Data Review, CSR Analysis/Verification/Peer review, and electronic Regulatory Submissions production.

CTMS, Impact,

IMPACT (International Management Package for Administration of Clinical Trials) is a highly flexible, web based, tried and tested CTMS. It caters for all trials, from large multi-national trials to single site, investigator-sponsored protocols. The product provides planning and tracking support for all aspects of a trial and consolidates all the information from various collection points into a single source.

InForm Clinitrial Clinitrace

Phase Forward's scalable, reliable solutions suite – which integrates electronic data capture (EDC), clinical data management (CDM), and drug safety monitoring – accelerates clinical productivity and streamlines drug safety monitoring and reporting.

Esendant Clinical Network

PHT's Esendant Clinical Network fully conforms to CDISC standards and is compliant with FDA 21 CFR Part 11.

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