Real-time data collection and reporting capabilities can improve product quality and reduce compliance time by:
Replacing labor-intensive, time-consuming manual processes for reporting formation, including manual copying, distribution and maintenance of procedures and equipment log books.
Maintaining data fidelity and control.
Providing data integrity, security and control with electronic signature and record rules.
Supplying meta-tag data definitions.
Managing electronic review, approval, publishing and change-control processes.
The reduction of transcription errors pays off in reduced time spent on quality assurance activities. By using such systems, some manufacturers have reduced the time spent on deviation investigations by almost 75 percent.
Although the benefits of using an integrated asset management system based on predictive maintenance methods are numerous, the beauty of the system is the tracking and control reporting, which can reduce abandoned batches dramatically.
By using an XML-based asset management system, manufacturers can integrate and reuse data elements easily with different applications. Thus, an asset management system and equipment tracking and calibration applications all can reside on the same server, and users can access the applications via a Web browser.
A zero-client implementation eliminates the cost of loading and maintaining the application software onto each client device. In a zero-client implement- ation, no application software other than the actual Web browser is installed on the client device. The zero-client application design provides tremendous cost benefits to pharmaceutical manufacturers in deployment, scalability, maintenance and validation.
The value of these systems is enhanced further when the systems are integrated with existing software applications such as enterprise resource planning, laboratory information management and electronic document management systems.
Although the benefits of integration are clear, the job often proved to be too cumbersome and expensive in the past. Proprietary data file formats required customized application program interfaces, which were difficult to maintain and keep validated. By using an XML file format, servers now can exchange information more easily with one another.
You can do it
For years, integrated technology has been heralded as a worthwhile ," but difficult to attain ," pursuit. With the development of Web-based systems technology, the possibility of integrated data, systems and information now is within the grasp of virtually all pharmaceutical manufacturers. An integrated system is just the prescription for an industry that stays competitive by bringing products to market in a timely and efficient manner.
Cochran is a vice president with Decision Management International (DMI), Bradenton, Fla. DMI is a provider of software and implementation services for FDA-regulated manufacturers. He can be reached at firstname.lastname@example.org.