Compliance Management Systems
Solution Center


The Pharmaceutical industry faces the task of meeting all FDA regulatory requirements including ISO 13485 and 21 CFR Part 11, and other ISO compliance standards. From discovery to clinical trials to patient delivery, introducing quality assurance to pharmaceuticals and their markets is often a long, involved process.

Staying on top of regulatory requirements while producing safe and effective products is vital. More and more companies are turning to highly configurable, flexible Quality and FDA Compliance Management Systems to adapt to the ever-changing regulatory landscape.

Here you’ll find white papers, application notes, webinars, and user communities designed to answer your FDA Compliance questions. Links to Social Media keep the conversation going, and put you in touch with other users.

Sponsored by EtQ, Inc.

Technical Resources

Enhancing Collaboration With the FDA Through eMDR

This white paper provides a detailed overview of the FDA’s eMDR program as well as the benefits and best practices of using the FDA’s Gateway.

Managing your Risk Has Its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes

This article will examine a real-world example of how using a risk assessment model in a QMS can identify critical events, mitigate the risk, and prevent re-ccurrence of these events.

Keeping up with the New Pace of Business: How Risk Management Tools Can Improve Product Quality in Today’s Rapid Lifecycles

This white paper will look at how risk management provides the framework for handling adverse events in a systematic way—from design, to post-market events, to tracking and trending risk across the enterprise.

Pharmaceutical Compliance that Spans the Supply Chain: Considerations for Extending the Quality System Beyond Your Enterprise

This paper will explain how suppliers will benefit from being included in harmonization initiatives and will discuss the best practices of extending the quality system to the supplier.

Selecting, Implementing, and Using FDA Compliance Software Solutions

As the world market evolves, product lifecycles are speeding up to accommodate market demand and keep up with competing products. As a result, Quality benchmarks need to evolve as well.

About EtQ, Inc.

About EtQ, Inc. is a complete quality and compliance safety solution provider dedicated to delivering leading edge software solutions. EtQ is focused on emerging technologies and dedicating resources to assure that EtQ software maintains compatibility with industry leading standards and best-of-breed functionality. EtQ is dedicated to continuing its customer focus to define EtQ Reliance as the market leader and its customer's preferred choice for enterprise quality systems and compliance management solutions.

Contact Us

EtQ, Inc.
399 Conklin Street
Suite 208
Farmingdale, NY 11735
info@etq.com
www.etq.com

Key Products And Solutions

Life Science Solution

EtQ’s GMP Compliance Management Software system has been designed specifically for the Life Sciences industry. Using best in class integrated modules and enterprise application integration, EtQ helps manage and measure quality and compliance processes, and executes organizational change through a flexible workflow platform that adapts to changing business processes, without programming.

CAPA

The Corrective and Preventive Action module generates a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. Multiple reports are generated automatically to provide an effective mechanism for tracking the source and costs of problems.

Document Control

EtQ’s Document Control manages the creation, approval, distribution, and archiving of all controlled documents. It is ready-to-use for such document types as manuals, procedures, work instructions, forms, job descriptions, product specifications, inspection specifications, test methods, and much more. Users can even use their current documents that are in any MS Office™ application (e.g., MS Word™).

Audit Management

EtQ’s Audits module automates the process of auditing and surveying, including internal audits and customer satisfaction surveys. All features of each audit or survey type can be configured without programming. Some key user-definable features include: checklists, question library, evaluation method (numerical scoring or counting), and more.

Enterprise Reporting

EtQ’s Reporting utility comprises three tools. The Rollup tool pulls data from multiple applications to generate global reports. EtQ Charter lets users take data from any module and present it in a spreadsheet with a graph presented in Microsoft Excel™. Quality Alerts lets users monitor and track similar quality events and characteristics, and notifies them when such characteristics occur.

Operational Risk Management

EtQ’s Risk Register calculates risk using a variety of techniques, updates risk at multiple points in the process, and displays risk mitigation history by event. It also features the ability to integrate risk tables within all of EtQ’s modules, as well as risk charts to identify key risk indicators.

EtQ, Inc. is a complete quality and compliance safety solution provider dedicated to delivering leading edge software solutions. Founded in 1992 by former lead auditors of Underwriters Laboratories, EtQ has always had a unique knowledge of quality and compliance processes, and has always strived to make overall quality operations and quality systems better for businesses. Focused on emerging technologies and dedicating resources to assure that EtQ software maintains compatibility with industry leading standards and best-of-breed functionality.