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Overview
The pharmaceutical industry is among the most heavily regulated, both in the product development, clinical trial and manufacturing phases. The nature of this industry demands the highest standard of production precision and detailed product and process reviews. This stringency calls for a robust software solution that can address the most complex process and quality requirements in a secure, easy-to-use and scaleable manner. MetricStream’s application suite is a leading solution that will significantly enhance quality tracking and process efficiency optimization in pharmaceuticals manufacturing.
Research has indicated that the key areas of focus for manufacturing in the pharmaceutical industry are the following.
Supplier Evaluation
Large manufacturing supply-chains use networks of chemicals suppliers that are subject to incoming quality inspections (IQA) and periodically evaluated against conformance to industry standards. This creates a need for an automated solution to manage the supplier performance tracking and measurement process, as well as the ability to create and electronically maintain non-conformance documentation and contracts.
Compliance with Federal Regulations
21 CFR Part 11 of the code of federal regulations; Electronic Records; Electronic Signatures sets forth the requirements for the creation, modification, maintenance, archival, retrieval of electronic records and also the use of electronic signatures when complying with the Federal food, drug, cosmetic act or any other FDA regulation. This requirement creates a need for companies to convert internal document reviews and approvals, as well as external interaction with regulatory agencies (specified by public docket No. 92S-0251) into electronic form using a reliable software infrastructure.
Complaints Management
Pharmaceutical companies are particularly sensitive to ensuring proactive responses to customer complaints arising from customers during the drug development, trial and production phases. Complaints need to be managed through a defined resolution process and trigger the appropriate corrective action/preventive action (CAPA) procedures, while maintaining an audit trail for future verification. To address this issue, companies need to adopt a system that is capable of configuring process flows and enables easy tracking and resolution of complaints.
Training and Certification
The technical nature of pharmaceutical manufacturing necessitates a methodical process of factory floor employee training and skill set tracking on production equipment. Extensive documentation including training manuals, standard operating procedures and regulatory guidelines need to be maintained and also closely controlled for accuracy of revisions and updates. Companies need to establish controlled closed systems with secure access to training documents and services in conjunction with digital signatures (Part 11 Subpart –C) to eliminate paper-based routing and approval methods.
Audits and Inspections
Pharmaceutical companies’ business processes, documentation standards and corrective measures are regularly subject to rigorous inspection from the FDA to ensure compliance with federal quality and safety standards. Audit failures result in the dispatch of FDA Form 483 to notify the companies of standards violations and suggested remedial measures. The need to manage and maintain the audit and inspection related documentation in electronic and human readable form through a set of software applications is paramount.
Metrics Management
Executives at Pharmaceutical companies need to be informed of the status of the various elements of the production system through a set of high-level metrics. These metrics, which include cost of quality (COQ) and assist in identifying system inefficiencies and propose corrective actions. In addition, production managers and factory floor supervisors need to monitor certain key events and exceptions that could potentially result in lowered customer satisfaction and lost revenues.
The MetricStream Solution
The MetricStream QMS is ideally positioned to address the process automation and regulatory requirements of the pharmaceutical industry through its robust and tightly-integrated application modules. Using a 100% Java and XML-based server architecture, Quality*Stream’s dashboard, audit, Training and Non-conformance modules provide standards-compliant solutions to the key industry problems.
MetricStream’s addresses the industry’s key business needs through the following product features and functionality.
- The Dashboard system provides real-time snapshots of the quality measures across the extended supply chain including cost of quality, unresolved corrective actions, and supplier performance parameters.
- The document control module enables the creation, maintenance and retrieval of critical process and quality compliance documents relating to suppliers and internal quality through a secure web interface. The workflow feature also enables the automation of document approvals and escalation procedures
- The highly configurable alert notification feature allows monitoring and tracking of adverse events, as well as generates sophisticated containment and corrective actions based on root-cause analyses
- MetricStream’s training module, which is due for release in late 2002, will significantly reduce the cost of training and increase customer service levels through the automated management of class schedules, online training and certification, and employee skill-set tracking
Technical Details
- Fully web-based with an intuitive, easy-to-use user interface
- J2EE and XML compliant, n-tier architecture
- Runs on Windows NT and Solaris
- Tightly integrates with Oracle Manufacturing, Financials, HR and other third party applications
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