CSC Webinar: FirstPoint Drives Quality Management
Thursday, September 20, 2012 10 a.m. Eastern / 3 p.m. British Summer Time
Drug and device manufacturing requires a focus on quality unsurpassed in any other industry. Tight regulatory criteria and inspections are vital in an industry whose products have such major impacts on the health and safety of patients. Quality management is necessarily integral to good manufacturing practice and to ensuring that products brought to market are safe and consistent. Poor quality is costly in every way - to the patients who use the products and to the companies themselves, which face millions of dollars in fines and even more in lost revenue from products withdrawn from the market.
Quality Management solutions target adherence to quality standards and compliance through automated and standardized processes aimed at identifying, mitigating and, ultimately, preventing noncompliance events.
CSC has responded to the needs of life sciences manufacturers by creating FirstPoint Quality Management, which helps clients manage and track all of their quality events and related documentation within one centralized, secure repository. The Quality Management solution is fully integrated into the FirstPoint Enterprise Content Management suite, making it a cost-effective, intuitive approach to managing quality and compliance.
The FirstPoint Quality Management electronic document management system (EDMS) module effectively records and tracks deviations, incidents, trends, complaints, nonconformities, regulatory investigations, audit findings and other quality events from initiation to completion.
To help clients understand the issues surrounding quality, such as corrective action and preventive action (CAPA) and how to put the FirstPoint Quality Management solution to best use, CSC is presenting a complimentary one-hour Webinar.
Discover how the FirstPoint Quality Management solution:
- Improves managerial oversight of a company's quality processes
- Helps assess the company's overall quality management practices
- Classifies and addresses nonconformance issues
- Connects more than one quality record to an investigation
- Attaches all supporting documents to a single quality event, investigation or CAPA record
- Traces a quality event from initiation through to the CAPA effectiveness review
- Electronically manages all documentation relevant to an investigation such as investigation plans and investigation reports
- Assigns individual tasks to multiple users to perform the implementation of CAPA
- Runs reports that lead to greater managerial oversight and control of the CAPA process
About the speakers
Jessica Kelley is a business analyst and quality and manufacturing subject-matter expert in the FirstPoint product group. Jessica has overseen many global enterprise-resource-planning and EDMS implementations and brings that expertise to assist with the continuous enhancement and development of the FirstPoint product.
Ron Milowicki is FirstPoint program director. Ron's expertise in EDMS spans 15 years, including serving as product manager on FirstDoc as well as large-scale EDMS implementations in the life sciences.
Recorded on September 20, 2012 - Register to receive webinar recording