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Product category: Plantwide control
News Release from: Honeywell Industry Solutions | Subject: POMS CMS
Edited by the Engineeringtalk Editorial Team on 18 August 2003

Software keeps track of FDA regulations

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GlaxoSmithKline has adopted POMS CMS enterprise production management at its research and development facilities in the UK, and at its product development facility in the USA.

Honeywell Industry Solutions has implemented POMS CMS enterprise production management at GlaxoSmithKline's research and development facilities in Tonbridge and Stevenage in the UK, and at the company's product development facility at Upper Providence, Pennsylvania GlaxoSmithKline, a leading research-based pharmaceutical company, has invested $500,000 in POMS CMS to ensure consistent deployment of best business practices across the three sites

The system also supports compliance with 21 CFR Part 11, a US Food and Drug Administration regulation that sets standards for electronic record keeping.

"It integrates best practices with quality and regulatory compliance, which enables us to minimise risk, and eliminate unnecessary delays during our chemical development processes", said D.

Dermot Moynihan, Senior Vice President, Chemicals Development, GlaxoSmithKline.

Using POMS CMS, GlaxoSmithKline can manage raw materials, intermediates and consumables during product development, ensuring that it controls and uses materials and resources more efficiently.

The system supports several key functions, including raw material identification, material receipt and labelling, material status, material issue and return and warehouse management.

It also supports reports and queries.

POMS CMS provides complete traceability through all stages of clinical supplies processes, from raw materials to shipment to the investigator and returns.

Inventory management and recipe-based interactive electronic batch record capabilities reduce compliance costs and increase material supply efficiency for increasingly complex and frequently changing clinical trials.

Honeywell pharmaceutical solutions enable customers like GlaxoSmithKline to take control of processes and environments across regulated facilities.

These solutions integrate best practices in every cost centre, including key areas like process control, environmental control and validation.

Honeywell minimises risk associated with maintaining compliance, while avoiding the high cost of being late to market.

Honeywell's automation solutions allow customers to meet current and emerging regulatory requirements such as FDA Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, GAMP and OSHA.

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