Lean Manufacturing Update

Implementing automated systems can help you make the best resource allocation decisions as quickly as possible, thereby increasing revenue and significantly reducing the cost of research, manufacturing, and sales. Those same systems can help organizations maintain compliance with some of the hairiest FDA regulations, including the US 21 CFR Part 11, one of the most demanding regulations for biotech industries.

In fact, these regulations, which affect the creation, maintenance, transmission, storage, and modification of electronic records, have recently added new priorities for the life sciences industry. According to Chemistry Today magazine, "21 CFR Part 11, in conjunction with existing GxP (good practices) inspections, promises to transform the management of electronic data in the regulated arena."

For manufacturers, this means that every system that generates electronic records required by GxP regulations must be examined to determine its current ability to comply with Part 11. This includes analytical instruments and techniques, Microsoft Excel and Word documents, laboratory information management systems (LIMS), supervisory control and data acquisition (SCADA), and manufacturing execution systems (MES). "From the lab to the enterprise and beyond, Part 11 significantly impacts the current good electronic record management practices."

Maintaining compliance
Dubbed "e-manufacturing," electronic record management enables immediate communication between the islands of shop floors, corporate business systems, and laboratory information management systems, so that the entire enterprise can act together to solve problems.

Going paperless can also allow one to manage the master data across the enterprise's physical boundaries. The first step is to electronically record data; the next step is to enable all of those disparate data types to be able to interact and work together.

Once implemented, e-manufacturing can generate reports that display deviations at a glance. For compliance, electronic records can be maintained throughout their required retention period in a safe, retrievable environment complete with audit trails to protect record integrity.

Eliminating paper
Creating and managing an electronic device history record (electronic records, electronic signatures, and ERES) that complies with FDA-enforced 21CFR Part 11 and Part 820 (Corrective and Preventive Action or CAPA) can be achieved with Oracle's electronic records framework within the Oracle E-Business Suite. Oracle's information systems help reduce waste and redundancy and facilitate the adoption of lean principles. Real-time feedback on process performance against established objectives provides a foundation for continuous improvement.

Oracle Clinical's remote data capture capability helps solve the problem of aged paper-based processes vs. new electronic record keeping standards. Paper-like forms are used to enter and store data electronically, and rules-based procedures ensure that data is checked as it is entered against standards established in Oracle Clinical. Discrepancies and inconsistencies are flagged and changes are captured in an auditable trail to ensure integrity of your records.

Reducing risk
In addition, medical device manufacturers must ensure that their products go to market with minimal risk. Oracle's Adverse Event Reporting system helps conduct safety and compliance monitoring and addresses 21 CFR Part 820 CAPA-required quality measures. Product safety monitoring and compliance help ensure that product complaints and adverse events are effectively managed. With Oracle AERS you can proactively monitor trends and gain insight into differentiators that can help maintain a lean manufacturing environment.

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