Answering to the Man

May 27, 2003

"The job's not over til the paperwork's done," is an old cliche that has taken on new ," and serious ," meaning in recent years. Regulations regarding documentation of processes, recipes and security arrangements are coming hard and fast, and no chemical company can afford to overlook them. Yet maintaining compliance takes more time, effort and money than many companies feel they can spare.

Software providers now offer new tools designed to help chemical companies manage these new regulatory burdens.

Compliance and quality

Document Control Systems Inc. (DCS) of Salt Lake City has introduced a Web-based software suite built on its new MASTERControl3 architecture. This open platform is designed to allow seamless integration of all MASTERControl applications, which the company says will "significantly" accelerate installation and implementation.

This initial offering consists of three applications: MASTERControl Portal, MASTERControl Documents FDA and MASTERControl Submissions.

MASTERControl Portal is the foundation of the system. It enables the integration of all MASTERControl Web-based content and quality management systems. It provides all the common services required for systems administration and regulatory/quality compliance, including:

Audit trails and electronic signature control that exceed the requirements for compliance with U.S. Food and Drug Administration (FDA) regulations, including 21 CFR Part 11.

Security components that control user name and password administration.

The portal's interface also allows users to locate all applications and commonly used functions easily for notification and document publishing.

MASTERControl Documents FDA is a Web-based version of DCS's MASTERControl FDA Edition, which is intended specifically for companies needing to meet FDA regulations. The company says that this version allows faster and easier implementation than earlier versions. It contains automated document routing, approval, escalation and distribution; drag-and-drop tools to create visual routings to develop workflows; and worldwide access via standard Web browsers.

MASTERControl Submissions provides complete document lifecycle management, drag-and-drop dossier organization and full publishing capabilities that meet FDA requirements. It provides lifecycle management of all GxP documentation, including that mandated by FDA. It organizes required electronic signature data and audit trail information and complies, organizes and publishes electronic dossiers for FDA submissions.

FDA meets EAM

The new spate of regulations require companies that fall under the purview of FDA requirements to be able to provide full process documentation for corrective maintenance, history records for standard operating procedures (SOP), inspection instructions and preventive maintenance records. For auditing purposes, documentation also must cover SOP, instructions and methods that define and control production, workmanship standards, production and process changes (including re-validation), environmental control procedures that could affect quality, equipment maintenance and inspection schedules and procedures for the use or removal of materials that might affect product quality.

FBO Systems Inc., Duluth, Ga., addresses these regulatory issues with its MLS enterprise asset management (EAM) system. The company says its system provides audit trails, security controls, tracking and record-keeping capabilities and scheduling and historic information necessary to meet FDA and other regulatory requirements.

MLS is a full-functionality EAM system that manages preventive maintenance, purchasing and inventory, equipment, work orders, service alerts, reporting, projects and utilities. It supports capital project management with cost tracking and asset history. All maintenance and overhead costs related to assets and equipment are visible through its advanced financial reporting capability.

Its security features include protection from unauthorized records alteration through restriction of equipment, master list, preventive maintenance and work order records access to members of the owner group. Records also are protected from alteration on the database level. MLS also offers electronic signatures consisting of the signer's printed name, date and time of signature and "meaning" ," for example, review, approval, responsibility, authorship, etc., associated with that signature.

MLS can be integrated with MFG/PRO enterprise resource planning system from QAD, Carpinteria, Calif., to give users an integrated view of the impact of EAM-related decisions on the enterprise as a whole.

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