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.
By incorporating suppliers into your quality and compliance activities you will add a greater level of assurance into the quality of product that your suppliers are providing, the safety of the product they are providing, as well as how each supplier compares to the other.
While there is a level of fear that exists when allowing third parties with access into your quality processes, the QMS alleviates these concerns with the addition of a cloud-based portal that allows all suppliers activities to take place outside of the actual QMS, ensuring that they only see what is necessary for them to see and keeping other data secure.
With compliance moving towards a Risk Management focus, building in risk technologies and tools is a great way to benchmark and measure compliance.
Risk terminology offers a common understanding of complex operational issues, and can easily be interpreted at all levels of the organization. Ultimately, if an operation can “speak” risk, it can drastically improve its ability to make an impact on compliance within a business.
Global Harmonization is the answer to keeping an organization common on a corporate level while maintaining each site’s unique method of doing business.
When effectively implemented, a Harmonized software solution results in a common culture of quality. Success in Global Harmonization relies on team members to compromise and help find areas for standardization, verifying that the process is successful, and maintaining the new process through continued governance. Standardization to this level ultimately results in consistency in processes throughout the enterprise.
Leveraging the emerging technology, Enterprise Quality Management Software (EQMS), market leaders in the life sciences industry are more effectively infusing quality, risk, and EH&S with processes across the value chain.
This LNS Research Spotlight will help executives on the quality journey understand the framework for building this holistic quality platform, empowering them to strengthen their existing strategies.
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.
EtQ is the leading Quality, EHS, Operational Risk and Compliance management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. At the core of EtQ’s framework is a compliance management platform that enables organizations to implement best-in-class compliance processes configured to meet their existing processes, create new compliance processes and automate and control their compliance ecosystem. EtQ’s product lineup includes traqpath™ for individual compliance users, VERSE Solutions™ for small to medium sized businesses and Reliance™ for enterprise organizations. EtQ was founded in 1992 and has main offices located in the U.S. and Europe. To learn more about EtQ and its various product offerings, visit www.etq.com or blog.etq.com.
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.