Improving Total Cost of Ownership with EQMS Companies are always looking for ways to improve product quality, customer satisfaction and profitability while at the same time dealing with increasing costs, competition and regulatory pressures. To address quality and compliance requirements, each functional area within a company often implements a point solution to meet specific needs. This approach has led to the proliferation of a wide variety of non-integrated systems that may help individual departments/divisions manage their responsibilities but have created data islands. Utilizing an Enterprise Quality Management System (EQMS) backbone to manage quality and regulatory issues enables a broader and deeper view across the organization. By using this backbone approach, an integrated Enterprise Quality Management Solution becomes an investment, instead of an expense. An enterprise quality management solution provides tangible benefits such as increase in revenues and margins, operational efficiencies, and global standardization for external and internal stakeholders and suppliers.
A Business Case for an Enterprise Quality Management SystemToday’s manufacturers face enormous challenges managing their enterprise quality and compliance initiatives. Market trends point to even greater scrutiny of these efforts as pressure mounts from both consumers and regulatory agencies for manufacturers across a broad range of industries to deliver better, safer products and services. The cost of non-conformance continues to grow. To meet these challenges, it is imperative that manufacturers have a quality management system to manage processes and provide timely access to relevant data. This white paper will act as a step-by-step guide to help readers get started with the system selection process, lay out requirements and identify the right internal stakeholders, and set up the business case for an Enterprise Quality Management Software (EQMS).
Medical Device Quality Systems Demystified: Why Companies Need Best-of-Breed ERP, PLM and EQMSMedical device companies that choose to leverage ERP or PLM to handle EQMS capabilities are really electing to fall behind the competition by placing themselves at greater regulatory risk. They also are likely to spend more money than if they chose the path of implementing a best-of-breed EQMS system and integrating it into their system landscape. Download this white paper to learn more about how investing in EQMS can actually support organizational goals of implementing systems with low TCO.
Automated Audit ManagementToday’s best-in-class enterprises are moving from manual, disparate and siloed audit management to centralized and automated audit management solutions. This whitepaper describes how audit management solutions enable life science companies to reduce audit time and cost, mitigate risk and ultimately help improve product quality and safety. It also suggests elements to consider when choosing an audit management solution.
CAPA: Why It Still MattersAn examination of the reasons why many organizations have yet to adopt an effective closed-loop CAPA (corrective action and preventative action) management process. Why organizations are reticent to adopt effective CAPA management, why some are so far behind in the methods they’re using, and what will it take for companies to realize that CAPA management doesn’t need to be as much of a drain on time and resources as they think. In addition, the white paper explores the needs and effectiveness of correct CAPA control, how to implement a successful system and examines just why CAPA still matters.
The Challenges of Complaint Handling, Investigations and Adverse Event ReportingA look into how an enterprise quality management system (EQMS) can help manufacturers boost product safety by improving data integrity, workflow and communication consistency and regulatory compliance, learn how these software programs provide organizations with a centralized, consistent and standardized mechanism for recording, tracking and trending customer complaints, investigations and adverse event reporting according to regulatory standards.
Electronic Reporting: What You Need to Know to Comply with eMDR eMDR, electronic medical device reporting, is an efficient method of submitting vigilance reports to the Center for Devices and Radiological Health (CDRH) at the FDA. Top medical device manufacturers, distributors, and reprocessors have implemented automated eMDR systems and, as a result, are benefiting from improved data accuracy, faster response from CDRH, and cost savings from the elimination of repetitive data entry, and even paper and shipping costs. An analysis performed by the FDA indicated that companies can save almost 80 percent by submitting reports electronically rather than by paper. Leveraging existing system capabilities will lead to additional incremental savings. Compliance with reporting regulations can be achieved in two ways, via paper reporting or electronic reporting. This paper will focus on the electronic reporting method, specifically the high-volume eMDR solution, as forward-thinking companies are moving away from traditional paper reporting and adopting eMDR as the best practice. Enterprise-Level Change Control: A Life Science Business Imperative When internal or external forces challenge production standards, related processes, specifications or even critical documentation, controls must be put in place to ensure that product quality is not compromised. People’s lives and the manufacturer’s reputation can be at stake, and product irregularities simply cannot occur.
Enterprise software systems on the market today can provide this level of management and control, and in turn, can even improve productivity, reduce production costs, ensure compliance, reduce risk and more. These tightly integrated, comprehensive systems work to evaluate changes as well as manage, track and record them to ensure product quality. They also provide the necessary level of automated communication to those people who are affected by the change, as well as those responsible for overall product quality.
EQMS Coexistence in an Enterprise Environment A topic with which industry professionals have wrestled for a number of years is the extent to which they should repurpose existing applications for the function of managing quality systems processes. Central to this discussion is the question of how – or if – an organization’s ERP should be extended for use in the quality systems area.
This paper examines the macro-level trends in both the ERP and quality systems application spaces, as well as key issues that should be considered by those considering whether to extend a company's ERP system for use as a quality management systems.
In addition, learn why organizations will achieve the most effective holistic quality system with the fastest time-to-value and time-to-productivity for their investment using a purpose-built enterprise quality management application with the appropriate integration with their other existing enterprise systems.
Technology Approaches to Quality ManagementOrganizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations. These pressures stem from a number of different areas including a wide range of international regulatory authorities, global customers and other key stakeholders. More recently these same organizations have been faced with increasing economic pressures to increase operational effectiveness and efficiency while still being tasked with maintaining an optimal level of quality.
Learn how the presence of software solutions in the quality arena have progressed gradually from a deployment of tactical point solutions to complete, enterprise-level solutions and how these total solution offerings can drive down the cost of ownership of an enterprise quality management solution.Analyst Reports
Forrester ConsultingBeyond Compliance: The Strategic Role of QMSThis report explores how software decision-makers in regulated industries are approaching QMS solutions as a means to not only meet regulatory demands but also, increasingly, to drive mission-critical operational goals beyond compliance, such as market-differentiating product quality, business efficiency, and time-to-market.
AMR ResearchFood and Beverage Manufacturers: Avoid TREAD Act Déjà Vu and get a Grip on Quality Now In a study of 90 food and beverage companies on quality management strategies and architecture, AMR Research found significant business process performance hurdles, with data analysis and corrective and preventive actions (CAPAs) being the most glaring gaps.
Aberdeen GroupThe Cost of Quality Benchmarking Enterprise Quality Management Aberdeen examined the use, the experiences and the intentions of 146 companies that are focused on reducing the cost of quality. Survey results were combined with interviews to provide readers with actionable steps for reducing the cost of quality while manufacturing higher quality products in compliance with government regulation.