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Secure Desktop 6.83

21 CFR Part 11 (FDA) - Secure Desktop has several features to aid the pharmaceutical, biotechnology, food, and beverage industries. Using Secure Desktop, program and data access can be controlled, user activity can be logged to disk, and users can be automatically logged off from Windows NT 4.0 or 2000 due to inactivity.

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

SLIM

21 CFR Part 11 Compliant; “All changes are event logged. Audit trail includes references to the date and time of the change, the user making the change, the event type that caused the event to be logged, and description. When data results are changed a change code and comments are logged. Multiple levels of security. “

eGMP

A complete, integrated software solution that enables companies to create custom enterprise software. The eGMP software suite comes preconfigured with custom data table templates, enables companies to manage ALL aspects of workflow, from SOP, Specifications, Methods, Validation Reports, Qualification Protocols, and Design Reviews to time card management, procurement, inventory and more. eGMP has a complete security model built in. eGMP is compliant with FDA regulations, including 21 CFR Part 11.

A-S Login

A-S login provides complete 21 CFR Part 11 compliant user login functions, and a comprehensive administrator console. The software uses complex encryption and checksumming techniques to protect data from accidental or deliberate falsification.

TrendReader Standard Data Logger

ACR Systems TrendReader Standard Data Logger Software, includes data validation that permits our software and hardware to conform to the FDA’s 21 CFR Part 11 regulations. 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.

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.

Cerity

Agilent Cerity Networked Data System for Pharmaceutical QA/QC data system is part of the Agilent Cerity networked data system family of chromatography software. (Formerly Chemstation.)

adWATCH

All of Winchester Business Systems' products and services comply with the requirements of the FDA's 21 CFR Part 11 for electronic signatures and electronic records using the ComPac software module.

Analyst SQL LIMS

Analyst™ software. Automated software routines rapidly and completely optimize the instrument for quantitative analysis. Queries, metric plots, configurable results table, and slide show. Analyst software provides flexible data acquisition, fast and easy data. SQL*LIMS® software is a complete 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.

Argus Safety Easy Trak

Argus Safety ™ Features: 21 CFR Part 11 Compliant ICH E2B - Electronic Submission ICH E2C - PSUR Compliant with current MedDRA™ versions CIOMS V EasyTrak ™ Features: 21 CFR Part 11 Compliant Meets FDA complaint handling requirements Integrated adverse-event reporting for FDA and EU Device Vigilance Reporting Return Goods Authorization Alternate Summary Report

IntoPlus.21 & Batch 21, eBRS

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.

Aspentech

Aspen Technology, Inc, is the leading supplier of integrated software and solutions that enable process manufacturers to automate and optimise their plants and extended supply chains while enabling e-Business. AspenTech offers the industry's broadest family of scaleable solutions allowing our customers to be successful in the Internet economy.

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.

Avantis®

Avantis enterprise asset management system Foxboro I/A, Performance Measurement and Management Consultancy, Home Contact, Upstream Personal Healthcare Pharmaceutical Power Pulp and energy chemicals and maintenance. Updating asset maintenance procedures. Performance Measurement and Management group can help

DaonSign

Biometrically secured electronic signing capabilities for the Pharmaceutical Industry. Daon's e-signature solution adheres to Worldwide Regulations & Legislation around the use of electronic signatures.

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.