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Integrated Quality and Compliance Management |
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| A Unified Approach for Better Business Performance | ||||||||||||
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Traditionally, homegrown systems, stand-alone applications or even paper or spreadsheet based systems have been used to manage product and process quality or compliance (such as cGMP). These solutions are typically implemented at the plant or departmental level. Such point-solutions, while designed to track product and process quality data, fail to address systemic quality problems as they lack a broad enterprise reach. Additionally, these systems do not have the mechanisms to manage by exceptions - as a result things slip through the cracks. The risks from not meeting regulatory compliance requirements include fines, severe penalties from regulatory bodies and loss of brand equity in the market place. Risks from non-compliance with quality standards or industry mandates include loss of key customers, higher internal manufacturing costs and delays in customer shipments. As a result, organizations are now implementing systems with a closed loop quality process, define and execute an enterprise-wide approach to quality and compliance management and leverage automatic notifications to ensure that nothing falls through the cracks.
The embedded best practices for supporting key processes and requirements for standards and regulations such as ISO 9000, FDA 21 CFR Part 11, Part 820 Quality System Regulation and ISO 13485:2003 lower the cost of regulatory compliance and risk of noncompliance. MetricStream offers a system that supports 21CFR Part 11 compliance and streamlines key clinical, laboratory, manufacturing processes and procedures including: out-of-spec/non-conformance tracking, change control, integrated document management, electronic signatures, complaint and adverse event management and reporting on form 3500A or baseline form 3417 etc. Integrated Quality and Compliance Management SolutionThere are three major quality management processes in an organization - supplier quality processes, internal quality processes and customer quality processes. These processes may typically require compliance with a quality framework or guidelines such as ISO 9000 or CMMI or 21CFR Part11/cGxP. Historically these quality processes have been managed in silos. Best practices call for supplier quality, internal quality and customer quality processes to be managed using a single underlying quality management system, since the resolution of customer quality related complaints may require working closely with one or more internal manufacturing sites and even a certain supplier to address the root cause of the issue. A single system makes it easy to track and manage the process, ensure the issue has been resolved and response communicated to the customer. A single system makes it easy to aggregate quality-related metrics from downstream sites and report it to customers. Finally, a single underlying system also provides the organization a 360 degree view of quality-related risks.
MetricStream offers comprehensive quality and compliance management software solutions for managing quality programs within an organization, for streamlining quality processes involving suppliers and customers, as well as for managing operational regulatory compliance such as FDA cGXP, OSHA, HACCP, JCAHO etc. By improving operational efficiencies in their quality processes, MetricStream enables companies to create a transparent environment for proactively identifying, tracking and resolving quality issues. Moreover, the embedded best practices for supporting key processes and requirements for standards and regulations such as ISO 9000, FDA 21 CFR Part 11, Part 820 Quality System Regulation and ISO 13485:2003 lower the cost of regulatory compliance and risk of noncompliance. For companies in life sciences space, MetricStream offers a 21CFR Part 11 compliance system that supports key GXP compliance issues for clinical, laboratory, manufacturing procedures including out-of-spec/nonconformance tracking; change control; integrated document management; electronic signatures; complaint and adverse event management; reporting on form 3500A or baseline form 3417 etc. Leading companies in life sciences space are already using MetricStream to manage their FDA compliance. In addition, MetricStream’s ComplianceOnline.com, a leading portal and online community for worldwide professionals, provides the latest information, best practices, training, products and tools on GRC. The combination of a powerful software platform, rich content and access to a large community of compliance professionals provides a powerful solution in an environment where the regulations and requirements are continuously changing and keeping pace with them and managing them effectively is essential to reducing the overall risk. After evaluating solutions from multiple vendors, NASDAQ decided to offer MetricStream solutions to all its listed companies to enable them to better manage their quality and compliance initiatives Internal Quality ManagementManufacturers strive to differentiate on the basis of product quality. The growing mix of complex products and global expansion of operations requires a new approach to quality management. Many organizations are deploying either industry standard quality management methodologies such as Six Sigma and ISO 9000, or implementing other quality practices to reduce costs, shorten cycle times and improve overall product and process quality. This has created a need for organizations to have visibility into their quality processes and to implement systems that ensure closed loop quality processes and support easy access to and efficient routing of information. Traditionally, homegrown systems, stand-alone applications or even manual paper-based systems have been used to manage product and process quality at departmental level. Such point-solutions fail to address systemic quality problems as they lack a broad enterprise reach. As a result, many companies are seeking to deploy enterprise class solutions that can unify quality management across their worldwide operations. MetricStream offers industry's most advanced and comprehensive suite of quality management solutions. Leading companies are replacing their point solutions and paper-based systems with MetricStream solutions to automate their quality management processes, gain real-time visibility into their quality metrics, and reduce the costs arising out of poor quality. Some of the best practices being employed by leading global manufacturers by leveraging MetricStream solutions include: Internal Quality Management
Closed Loop Processes: MetricStream ensures that all quality processes are well integrated to create a unified and seamless environment for quality related issues and data. The solution tracks events as they move from one stage to the next, even across departments and groups, to ensure a closed loop quality management process. For instance, a document change can initiate a training request and CAPAs triggered as a result of audit findings are tied to the audit. Streamlined Corrective Actions: MetricStream allows users to engage cross-functional teams to collaborate on development and implementation of corrective action plans. It enables triggering CAPAs, performing root cause analysis, assigning follow up actions while effectively tracking and routing cases from initiation to closure. Efficient Audit Management: MetricStream allows conducting frequent internal audits to ensure that the established product and processes quality requirements are being followed. It provides capabilities to efficiently plan, schedule and conduct audits, allows audit findings to be reviewed and analyzed by a team, enables initiation of follow-up activities such as corrective/preventive actions when needed, and provides the ability to monitor the entire process. Implementing Document Control: MetricStream streamlines document management and control processes for documents such as SOPs, batch records, regulatory filing, and quality reports. It enables companies to adopt an electronic and automated approach to managing and control documents across the enterprise with a centralized repository and tools for collaboration. Tracking Nonconformance: MetricStream accelerates non-conformance review and approval cycles with automated workflow. It supports recording and automatic rule based routing of nonconformance issues for review and disposition by the Material Review Board (MRB). Real-time Reporting: MetricStream enables tracking quality issue and processes in real-time on executive dashboards and reports for data driven decision-making. It provides complete visibility into quality system database with comprehensive aggregate reporting as well as individual case status tracking. Graphical executive dashboards and flexible reports with drill-down capability provide statistics, analytics and trending.
Visionary organizations are realizing that handling and resolving product quality issues reported by customers in a consistent and predictable manner is key to customer loyalty and repeat business. A systematic approach towards customer complaint management also generates ideas for product enhancements and new products ensuring ongoing success. Moreover, companies regulated by the FDA or those adopting standards such as ISO 9000 comply with well-defined guidelines for recording complaints, responding to them, and resolving them Some of the best practices employed by leading global manufacturers using MetricStream Customer Complaints Customer Quality Management
Detailed Issue Recording: MetricStream enables recording and defining quality problems reported by customers in measurable and specific terms to ensure accurate verification and effective investigation. MetricStream also supports capturing details such as product identification markings and event environment for comprehensive investigation and reporting. Streamlined Corrective Actions: MetricStream allows engaging teams to collaborate on development and implementation of corrective action plans. MetricStream enables triggering CAPAs, performing root cause analysis, assigning follow up actions while effectively tracking and routing cases from initiation to closure. Real-time Issue Tracking: MetricStream allows tracking
customer issue and complaints
management process
in real-time. It provides complete Product Changes: MetricStream enables Automating of review and approval workflows for product changes with standardized processes for initiating and communicating product changes. It allows systematic decision-making and timely communication to all affected customers as well as internal groups. Industry Standard Reporting: MetricStream supports automated creation of reports for investigation and resolution in industry standard formats to eliminate the manual effort and long cycle-times in consolidating data and information for external reporting. It supports generating investigation and corrective action reports in flexible industry standard or customer mandated formats and file types to streamline reporting to customers or regulatory agencies. Examples of such reports include 8-D report for issue resolution process and adverse event reports for compliance with FDA's reporting regulations.
The nature of an organization's relationship with its suppliers has dramatically changed. Global outsourcing and co-development is on the rise as companies increase focus on their core competencies. These changes have created a need for organizations to put in place a supplier quality management system to increase visibility into supplier quality and improve supplier accountability. Some of the best practices being employed by leading global manufacturers by leveraging MetricStream Supplier Quality Management solutions include: Supplier Quality Management
Supplier Access: Deploying quality management systems with web based access for suppliers enabling them to easily access and rapidly adopt a web-based superior quality management system. Even suppliers with basic IT infrastructure can access the application without any additional investment in hardware or software. Real-time Quality Analysis: Automating review and approval workflows for quality data in real-time by following a systematic process for collecting, plotting and analyzing inspection data to identify material nonconformance before lots are shipped. Issue Tracking: Tracking supplier nonconformance issues in real-time by establishing consistent procedures for components and lots that do not conform to specifications. MetricStream supports identification, evaluation, segregation, and disposition of nonconforming material as well as issue investigation and tracking. Streamlined Corrective Actions: Implementing a proactive approach to
supplier corrective action requests
(SCARs) or corrective/preventive action Supplier Charge-backs: Charging cost of poor quality back to the supplier for the costs incurred by a manufacturer due to nonconforming components, materials, and late deliveries in order to introduce business discipline and accountability into the supply chain. MetricStream supports recovery of both - material costs and processing costs associated with the nonconformance. It allows users to manage the end-to-end chargeback process - aggregate all costs from an incident, route for approvals internally and to the supplier, collaboratively resolve the disputed recovery amounts, and notify back office systems for financial closure. Supplier Scorecards: Monitoring supplier performance on scorecards to proactively identify and implement timely corrective actions improves supplier performance. MetricStream scorecards measure key performance indicators (KPI) in real-time and track improvements over time supporting sound decision-making based on data. Supplier Audits: Conducting supplier audits to ensure that suppliers meet the established product and process quality requirements and the audit process drives continuous improvement. MetricStream provides capabilities to plan, schedule and conduct audits, allows audits finding to be analyzed and enables the initiation of follow-up activities such as corrective action requests and reaudits.
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