Quality Metrics Overview on FDA Initiative
This whitepaper provides an overview of FDA’s Quality Metrics initiative for the Pharma industry, why FDA is implementing these guidelines and how technology will enable reporting on the necessary metrics once finalized.
Leverage your QMS Across Laboratory and Clinical Trial Drug Development
As clinical trials are increasingly outsourced to global contract research organizations (CROs), it has become more difficult for both sponsor companies and CRO partners to integrate and exchange data seamlessly. This whitepaper explains how technology solutions automate processes, streamline workflows and increase visibility for greater efficiency and safety for GCP and GLP.
Why Pharma companies need an EQMS
In this paper, we examine the regulatory, operational and economic challenges facing pharmaceutical executives today in an increasingly regulated business environment and how an EQMS delivers operational and cost benefits that transform quality management from a cost center to a revenue driver.
Drive Operational Efficiencies with Internal Audits for Pharma Companies
This whitepaper will explain the benefits of replacing inefficient manual processes associated with internal audits with an electronic, automated and integrated approach, allowing auditors to evaluate processes with greater accuracy and efficiency.
Reduce Patient Risk by Automating Complaint Management
This paper explores today’s regulatory environment and factors impacting complaint reporting, the risks medical device manufacturers face through failure to quickly and accurately identify and address complaints and steps to comply with regulations for complaint management to help improve business performance.
How Chemical Companies Increase Visibility across the Value Chain
In this paper, we examine the regulatory, operational and economic challenges facing chemical executives today as they work to deliver safer chemicals products in an increasingly regulated and competitive business environment; how a disconnected approach to quality management increases risks and costs for global chemical manufacturers; and, how an EQMS implemented as part of a company’s overall business strategy delivers operational and cost benefits that transform quality management from a cost center to a revenue driver.
A Quality Medical Device begins with Supplier Quality Management
Federal regulations mandate that manufacturers are responsible for ensuring the quality of their suppliers. Read this whitepaper to learn how technology help foster strong supplier relationships.
Driving Both Flexibility and Quality into the Discrete Manufacturing Environment
Discrete manufacturers produce and sell high-quality, highly complex products, while striving to improve quality, speed time-to-market, and lower costs. Learn how leading manufacturers balance flexibility and quality in this dynamic environment, where managing defects plays a significant role in the ability to stay competitive and profitable.
This whitepaper is also available in German.
Medical Device Manufacturing and the Journey from Better to Best
Learn how an automated CAPA system helps medical device manufacturers avoid expenses associated with FDA-initiated enforcement including product recalls, a stop on application for export, facility closure, and civil and criminal penalties.
Reducing Risks and Reaping Rewards: How an Enterprise Quality Management Solution Benefits the F&B Industry
Governing bodies around the world are enforcing new rules that require better traceability, improved visibility and more efficient process standardization from food and beverage manufacturers. Learn how to achieve a more holistic supply chain to keep up with this changing landscape.
Simplifying FSMA Compliance through Technology
The FDA Food Safety Modernization Act (FSMA) impacts food safety standards and imposes comprehensive product safety checks. Learn how today’s food and beverage companies are leveraging technology and automation to help achieve compliance, enhance traceability, and protect overall brand.
Minding the Ps and Qs: Managing Quality and the Globalization of the Pharmaceutical Supply Chain
This paper discusses how strong relationships between the manufacturer and all suppliers in the chain saves money through open communication and proven quality controls.
Quality Management in the Complex Manufacturing Environment
Complexity can impact quality. From global suppliers and contract manufacturers to service initiatives and production activities - learn how leading manufacturers are leveraging an enterprise quality management solution (EQMS) to coordinate business processes and IT infrastructure within complex operational processes, ensuring quality, improving productivity and supporting compliance across the supply chain.
Raising Quality Results on Supplier Audits using EQMS for Pharmaceutical Companies
Audit processes are an integral component of supply chain management. This whitepaper highlights the benefits of automating supplier audits to both the pharmaceutical company and partner suppliers that help strengthen the professional relationship.
Extending Control and Transparency into Supply Chains: How Cloud Technology Can Help With Supplier Quality
This paper examines the evolution of the supply chain, enterprise quality management solutions (EQMS), the supplier quality relationship, and the increasing pressure placed on manufacturing for improved quality. It will also explore ways that companies can regain control of supplier quality within today’s complex value chains through the use of cloud-based technologies.
The Value of Using Embedded Analytics with Quality Software Systems
Read how embedding a quality analytics solution enables manufacturers to take ownership over one of their most valuable assets--quality system data.
This whitepaper is also available in German and Spanish.
Protect Your Brand: Ensuring Food Safety and Compliance with a Quality Management System
Learn how market-leading food and beverage companies approach quality management to better manage the risk of quality and safety issues occurring across the value chain. By aligning and optimizing quality processes and data under one unified system, these companies leverage Enterprise Quality Management Software (EQMS) to protect their brand reputation.
This whitepaper is also available in French and German.
A Fresh Look at Quality in High Tech Manufacturing
This paper describes how companies that are looking to cut the cost of poor quality and improve margins can do so by elevating quality from a necessary cost of doing business to the level of a corporate mission—from a “department function” to a responsibility. The implementation of a holistic approach to quality, supported by an Enterprise Quality Management Solution (EQMS), should be a central focus of this mission.
Prevent Quality System Deficiencies by Conducting Effective Internal Audits White Paper
The primary function of internal audits is to evaluate the company’s performance against the requirements established by the company. An internal audit system is one of the most effective ways to monitor, analyze, control, and improve quality management systems for medical device companies. In today’s competitive medical device manufacturing environment companies are facing upcoming device tax, 510k reforms, and increased operational costs. By downloading this white paper you'll learn how having an efficient internal audit program is an effective way to manage these challenges and stay ahead of competitors without compromising on quality.
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 System
Today’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 EQMS
Medical 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 Management
Today’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.
The Challenges of Complaint Handling, Investigations and Adverse Event Reporting
A 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 Management
Organizations 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
Beyond Compliance: The Strategic Role of QMS
This 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.
Food 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.
The 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.