Honeywell makes Part 11 compliance achievable

Honeywell Automation and Control Solutions (ACS) Service has developed project delivery and validation framework services for industries regulated by the FDA, including pharmaceutical, nutraceutical, biotechnology and medical device manufacturing.

These enhanced services are enabled by Honeywell's industry-leading building automation system, Enterprise Buildings Integrator, with comprehensive electronic record and electronic signature capabilities. The company will begin delivering services based on this new solution in Europe, Middle East and Africa in September 2003. It will feature different European languages.

'This solution has been developed in collaboration with leading pharmaceutical and medical device manufacturers and is endorsed by a top-tier provider of advanced systems and validation services for pharmaceutical manufacturers,' said Gerald Goubau, vp and general manager, ACS Service, Europe, Middle East and Africa.

With its new service offerings, Honeywell is helping customers in FDA-regulated industries address the three-fold challenge of expediting time-to-market, improving operational efficiency and ensuring regulatory compliance. 'There is more emphasis than ever today on the environment within which critical-to-quality processes for pharmaceuticals, biotechnology products and medical devices take place,' Mr Goubau said. 'Conditions such as temperature, humidity, pressure, air particulate levels, human access to certain areas and other factors must be monitored, safely archived and easily retrieved in case of an FDA audit. Our service expertise and regulatory knowledge, coupled with this latest technology, provides the critical framework.'

The electronic record and electronic signature capabilities will help customers fully comply with all relevant FDA guidelines, including those specified in 21 CFR Part 11. These new guidelines allow manufacturers to replace most paper-based systems for monitoring and documenting adherence to current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) with electronic equivalents.

The Honeywell application automatically monitors and archives information - including original point values - about environmental factors such as temperature, pressure, humidity and access in research, production and storage areas. When an employee initiates changes in a validated environment, he or she can add notes to the system to explain the reasons for the change. Authorised employees can sign-off on these actions using electronic signatures that comply with Part 11 standards. In addition, all stored information is easily retrieved for historical and reporting purposes.

'Our best-in-class validation framework for environmental control can be expanded into process control to create a true, one-vendor control-and-compliance solution for FDA-regulated manufacturers,' said Mr. Goubau.

For customers, this 'one-stop shop' approach translates into lower training costs, administrative efficiencies, lower operational risk and improved productivity.

Mr. Goubau cited the experience of a top pharmaceutical manufacturer that is currently using Honeywell as its standard platform for heating, ventilation and air conditioning, as well as to monitor research equipment. The company's scientists use data extracted from the Honeywell automation and control system to submit environmental condition reports to the FDA with their research findings, reducing manual labour and ensuring cGMP and cGLP compliance.