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by: A Quality Management System should encompass collective practices to minimize nonconformances to specifications, standards, and customer satisfaction in an efficient and cost effective manner. Managing and overseeing theses multiple quality facets can be a daunting task for the Quality Assurance unit, especially when supporting start-up companies at very early product development. Frequently, the Quality unit is understaffed and required to wear multiple hats trying to balance the science with compliance. The growing pains when advancing from Phase 1, 2 to Phase 3 are numerous. Ideally, all essential Quality elements should be in practice to include controls of the production system, facilities and equipment, laboratory, materials, and packaging and labeling. Realistically, many systems may not be adequately in place. Systems currently in place should be assessed by performing gap analysis. Those systems that are deficient should be identified and prioritized based on risk assessment. Review of the Quality elements should be a joint effort with all departments involved to mitigate unnecessary deviations and to optimize the efficiency. Additional specific systems overseen, monitored or performed by the Quality unit:
Many of early phase companies are drowning in paper-based systems which often lend themselves to fail to address systemic quality problems. Paper-based systems cause clutter and stress the archiving systems. Batch and data retrieval are often difficult. Consideration should be taken to evaluate electronic quality management systems. It has been established that electronic quality management systems shorten cycle times and improve overall product and process quality through the ability to perform trend analysis and identify quality issues more timely. Most software packages are ‘out of the box’ and off the shelf modules which meet 21 CFR part 11. A few packages used in the life sciences include: Pilgrim, Master control, Title 21, Metric Stream and Sparta Systems. These systems generally provide validation scripts and provide ease of implementation. The electronic quality system vendor needs to address a best fit solution for the individual company. Ideally, one should purchase a one-time package that will address future growth to preclude another software purchase later down the road. The key to successful implementation requires thorough understanding of the work flows; this is where inter-departmental collaboration is required. Although cost may be a major budget constraint, many software companies provide discount to smaller companies based on the number of employees. There are many benefits of having an electronic quality management system which far out way the cost; shortened and improved batch release and improved product quality. Consultants from Biologics Consulting Group (BCG) are actively involved in assisting early stage companies struggling with implementation and optimization of Quality Systems. Additional expertise is available to include assisting with implementation of electronic quality management systems. If you are interested in learning more about how BCG may assist you, please Contact Ellen Raaf, MT ASCP.
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