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Corrective Action Preventive Action (CAPA)
Video Duration: 20 minutes

Centralized Reporting
Video Duration: 17 minutes

EtQ Designer Graphical Administration Tool
Video Duration: 7 minutes

Beyond CAPA: Using Risk Assessment to Streamline your Quality System
With all the processes associated with managing a quality and compliance management system, corrective action and preventive action (CAPA) is a prominent feature. In many cases, if an event is found in the system, a CAPA is generated. No matter the scope or severity, CAPA is the ultimate catchall for events in the system.

This paper describes a new risk-based methodology that will effectively reduce CAPAs as a whole. By employing this methodology, crucial CAPAs are extracted to determine the overall business impact, correct the problem, and implement the change throughout the enterprise.

Enhancing Collaboration with the FDA through MedWatch Plus
The FDA originally provided medical device reporting through the use of MedWatch forms (forms 3500 and 3500A). The MedWatch initiative began as a manual process and has recently evolved into a fully automated Web-based process, called MedWatch Plus, which enables companies to submit both voluntary and mandatory reports in one central location through the FDA's Electronic Submissions Gateway. This was put into place because the FDA believed one point-of-entry would better enable organizations to submit information.

This paper will give an overview of the FDA's MedWatch Plus program as well as the benefits and best practices of using the FDA's Gateway.

Food Safety, from Farm to Fork: A Best-Practice Approach to Implementing a Food Safety Management System
Globalization has made it cost-effective for manufacturers to purchase ingredients from lower cost countries around the world-but at what cost to consumers? As a result of the increase in globalization of the world's food supply and the ensuing food-scares, consumers are now, more than ever, demanding safe, quality food.

This paper will describe how automating your Food Safety Management Software system will streamline processes and procedures related to HACCP-ensuring compliance to regulations in the food and beverage industry. We will also look at how FSMS technology solutions are able to adopt a best-practices approach in implementing both HACCP and food safety initiatives, giving companies the traceability and transparency needed to provide a safe and quality product.

Improving Efficiency in the Recall Process by using a Quality Management System
Having to conduct a recall is one of the most trying experiences in any organization mandated by the Food and Drug Administration (FDA). There are regulatory issues to deal with, negative customer reactions, and a possible effect on market share, in addition to the cost to consumers and the FDA. While a recall may not be completely avoidable, there are steps that can be taken to mitigate the risk.

This paper will describe why Recall Management is a necessity in businesses today and how an automated Quality Management System (QMS) can streamline the process by enabling seamless compliance with the best practices of Recall Management.

An Insider's Guide to Selecting a Quality Management Software System
In recent years, enterprise software solutions have become commonplace in many organizations, whether integrated Quality Management Systems (QMS), or Quality Management modules within larger production systems, even down to simple point solutions for Document Control or Corrective Action. Recent reports on top software components for organizations show that Quality Management is at the top of the list. In many organizations, Quality Management and QMS systems are a strategic priority, and more software vendors are providing solutions for Quality and Compliance Management than ever before.

This paper discusses a few of the key considerations when selecting a software vendor, some pitfalls to avoid and technical considerations for ensuring the software system is a good fit for your business. We will make the business case for each consideration, and describe some of the technological points when selecting a software vendor.

An Integrated Approach to Air Safety: Integrated Airline Management for the Airline Industry
Airlines face numerous compliance challenges, including complying with regulations and initiatives set forth by the International Air Transport Association (IATA), and regulatory bodies. In addition to demonstrating safety compliance to IATA and regulatory bodies, airline firms must also demonstrate their achievement in safety standards to other members of IATA. The IATA Operational Safety Audit (IOSA) program is designed for the purpose of assessing the operational management and control of systems within airlines.

This paper will describe the Integrated Airline Management System, how implementation of an IAMS can improve operations, safety, security and quality, and what best practices are being implemented globally for IAMS.

Integration Management Connects Key Business Systems to Quality: Making the Case for Increasing Visibility into Status of Quality within the Enterprise
Quality Management Systems (QMS) are not excluded from this information silo scenario. In many cases, the quality system is a completely separate function of the business, and the connection between the quality system and other business systems is usually achieved through offline forms, periodic reports and verbal communication. While QMS play an important role in the assurance of product quality and process compliance, the business systems that control the products and run the process are "blind" to the status of the quality system.

This paper will discuss the concept of specifically integrating a QMS with enterprise business systems in order to create visibility into status of quality, transfer information to and from these systems and reduce product defects and process noncompliance, as a result increasing overall efficiency.

Localization: Streamlining Communications Across Continents
Many of today’s enterprises are no longer isolated to one corner of the globe—enterprises today span continents. With organizations sharing knowledge and information across these global enterprises, it is important to effectively translate all aspects of the software to ensure that communication is harmonized throughout the organization. Localization technology makes this possible.

In order for a system to be properly localized, it needs to be translated completely. This paper will illustrate what to look for in localization technology and what to avoid.

Managing your Risk Has its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes
In today's Quality Management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization. Whether it is tracking incoming customer complaints, identifying nonconforming materials from production, or using corrective and preventive actions (CAPA) to correct events within the system, having defined quality management processes in place can improve quality, reduce legal liability and make compliance a competitive advantage.

In this paper, we will examine a real-world example of how using a risk assessment model in a quality management system can identify critical events, mitigate the risk, and prevent re-occurrence of these events.

Quality Management and Change Management: Ensuring a Change for the Better
Change, as the saying goes, is the only constant. This also applies to changes to product or process. Regardless of industry - whether automotive, medical, or food for example - there eventually comes a need for change. As different as these industries may be, a drive for continuous improvement is the common denominator that initiates the need for a change. Inevitably, an organization will need to change a process or product at some point in its lifecycle in order to keep up with growing market demand and to keep pace with the competition.

This paper will discuss a few of the key considerations when selecting a software vendor, some pitfalls to avoid, and technical considerations for ensuring the software system is a good fit for your business.

Taking Quality outside your Four Walls: An integrated approach to Supplier Quality Management
In today's dynamic and demand-driven market, the need to implement enterprise technology to keep pace with rapidly evolving operational, production and compliance environments is key to success. In recent years, enterprise technology has become more prevalent in its penetration of all operational areas within a business. It has become so prevalent that it is rare to find a department within an organization that does not have a dedicated enterprise software solution to provide some level of support.

This paper will offer a "birds-eye" view into the Change Management process, showing the phases of Change Management from define and design, to approve, plan and source, to change execution and verification.

Uncovering the Hidden Factory by Integrating your Systems
There is a mysterious, secret hidden factory lurking in your organization, but don't go searching in the plant to find it. This factory is hidden because there is a lack of communication between your Enterprise Resource Planning (ERP) system or Manufacturing Execution System (MES), which is tracking nonconforming materials and your Quality Management System (QMS), which is tracking the corrective action of the process behind these nonconformances.

This paper discusses the "hidden factory" concept, and why it's important to utilize your resources to expose it and eliminate it. Integration of your QMS and ERP/MES systems is the key to not only uncovering the hidden factory, but also to effectively managing the components that make it up.

EtQ Document Management System
EtQ comes with a powerful Document Control application ideally suited to managing quality system documentation. However, many companies have already implemented document management systems (DMS), sometimes referred to as enterprise content management systems (ECM), and want to store their quality documents in the same document repository. The EtQ DMS Integration Tool makes this possible, while retaining all the benefits of EtQ's Document Control functionality.

EtQ Enterprise Configuration Center (ECC)
EtQ's ECC is able to roll-up company-wide data into quantitative reports that show top compliance risks across each site within the enterprise, enabling continuous improvement initiatives that span the entire organization.

EtQ for Environmental Health & Safety
EtQ for Environmental Health & Safety (EHS) is an integrated quality and compliance management system that has been pre-configured to specifically address the needs of the EHS industry, and maintain compliance to ISO 14001, OHSAS 18001, ISO 9000, Six Sigma and more. EtQ's unique modular approach provides unparalleled flexibility and automation. The modules are tightly integrated to deliver a best-in-class Enterprise EHS Management solution.

EtQ for Food & Beverage
EtQ for Food and Beverage is a flexible Food Safety Management software package that guides organizations through compliance with the ISO 22000 standard, the Global Food Safety Initiative's (GFSI) benchmarked schemes, HACCP, SQF, BRC, and IFS.

EtQ for Life Sciences
EtQ's FDA Compliance Software solution will guarantee compliance to regulations such as ISO 13485 and 21 CFR Part 11, by ensuring that an organization identifies, accesses, and evaluates laws, regulations, and internal regulatory requirements.

EtQ for Manufacturing
EtQ for Manufacturing is an integrated quality and compliance management software system that has been pre-configured to specifically address the needs of the Manufacturing industry and ISO 9000 processes.

EtQ Reliance 6.0
EtQ Reliance 6.0 is built on EtQ's unique Flexible Workflow Engine™, which allows the workflows, forms, sections, fields, reports, and even the look and feel to be configured without programming. Version 6.0 incorporates major enhancements designed to further automate Quality and Compliance Management Systems.

EtQ Project Control Module
EtQ's Project Control module is designed to organize and automate the process of managing tasks, deliverables and activities within Quality and Compliance projects. Using the Project Control module, Managers are able to outline specific project, whether on an ad-hoc basis or using pre-defined templates such as APQP, PPAP, Six Sigma and more.

EtQ Technology Brief
EtQ is committed to providing innovative technological solutions that meet the changing business and quality needs of its customers.

FUJIFILM
FUJIFILM Manufacturing U.S.A., Inc. implemented EtQ Reliance in 2006, to help unify its sites and consolidate the company's quality and environmental processes. As Fujifilm moves forward, they plan to expand EtQ Reliance to cover its process safety management and FDA regulations. FUJIFILM Manufacturing, U.S.A., Inc. has utilized the robust features and modules of EtQ Reliance to coordinate compliance efforts across multiple sites, combine crucial processes for quality and environmental management, and expand the quality and compliance system for the long term.

HydraMaster
HydraMaster continues to expand on the use of EtQ Reliance and with their past experiences have come to realize that businesses have two options—grow or remain static. For those that choose growth, they must nurture this growth through the use of flexible tools. Those who remain static will eventually outgrow their processes, and will ultimately be faced with a dilemma—grow or fall short. HydraMaster chose growth, and EtQ was able to help.