O.N.G. Automation are the official Rockwell Automation (Allen Bradley) and Foxboro I/A DCS Authorised integrator in Ireland, providing us direct access to the vast range of services and support which is available from both Companies. O.N.G. Automation has proven experience in the implementation of Control Systems from design stage through to final commissioning, In the Pharmaceutical, Biochemical, Food, Water and Electricity generation industries. We specialise in GAMP3 and 21 CFR part 11 compliant systems.

2.0 Dissolution data Management Software

The new Version 2.0 Dissolution Data Management software from Icalis Data Systems employ an extensive range of restrictive access rights to aid compliance to 21 CFR Part 11 and Online Sample processing with Auto samplers including sample dilution. An audit trail is kept of all activity in the system which is also user query able to help keep information in an orderly manner.

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.

Acceliant

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 21 CFR part 11

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

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.

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.

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.

ApproveIT

Meets FDA 21 CFR Part 11 right out of the box. ApproveIt from Silanis moves signature approvals on-line. Its native support for the most widely used document creation tools leverages your organization's existing communications infrastructure so you can continue doing business as usual, with little or no additional training.

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

ARCHIVE UNIFY VISION

NuGenesis provides an application-independent method for storing and cataloging raw laboratory instrument data as well as human readable information from common business applications. You can provide auditors with documented evidence back to the original source. NuGenesis Technologies products work as an application independent Scientific Data Management System (SDMS) which automatically aggregates data from disparate sources providing greater access and insight into critical knowledge generated in the laboratory. 21 CFR Part 11 compliance.

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

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.

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

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.

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.

cCure 800 security management platform

Software House Enterprise Solutions has years of experience building software solutions for the pharmaceutical industry. Some of our systems have been validated, and all of our work is done according to the high standards maintained in this demanding, regulated environment. Based on our own internal SOP's, our systems are built to comply with 21CFR11 (when required), with full implementation of electronic signatures.

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.)