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.
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.
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.
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.
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.
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.
This white paper discusses the benefits of connecting the supply chain to your quality system, how to alleviate security concerns, managing supplier performance and more.
This paper will describe the best practices for implementing a Pharmaceutical Quality Management System as stated by ICH Q10 as well additional aspects of a QMS that can go above and beyond in meeting pharmaceutical quality expectations.
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.
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.
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.
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™).
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.
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.
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.