Gould Life Science Suite

Data Security -An optional Data Security feature provides compliance to FDA 21 CFR part11

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

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.

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.)

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.

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.

UNICORN Control System,V4.1

Unicorn Control System version 4.1 was audited in May 2001 and was found to fully conform to all current and relevant US FDA guidelines and regulations including 21CFR part 11.

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.

Applied Stats SPC software suite

Our Applied Stats SPC software suite meets all the requirements of 21 CFR Part 11, and provides SPC data collection, analysis and reporting solutions for pharmaceutical manufacturing processes. ASI DataMyte Quantum software, coupled with our data collection devices, provides analysis and reporting capability for process control metrics.

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.

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.

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.

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.

Pinnacle

Pinnacle is the first CDS to be designed from the ground up to meet Part 11 requirements. 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.

MicroLog & OmniLog systems

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.

INDexxis

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.

BlazeLIMS Enterprise Plus

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.

StatLIA

Brendan develops laboratory software 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. 21 CFR Part 11 Compliant.

Mainsaver EAM

Cayenta's Computerized Maintenance Management Software is used by companies to minimize operation costs and maximize productivity. Mainsaver is a total solution for Enterprise Asset Management (EAM). Mainsaver offers a robust Enterprise Asset Management (EAM) solution, professional consulting services, implementation and training services and now compliance to FDA’s 21 CFR 11.

Chemstation Plus

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