FDA, EMEA & Global Regulation

A Perspective on Standards: A Tool for Global Competitive Survival in an Increasingly Complex Regulatory World

This paper by Rockwell Automation features executive viewpoints from leading standards, trade and conformity assessment organizations on why standards and regulations are important to global business, and why industry should care.

Achieving Compliant Manufacturing Excellence through Real-time Performance Management and Continuous Improvement

Many pharmaceutical manufacturing companies recognize that improving corporate performance demands better synchronization with the plant floor. At the same time, moving to a risk-based approach to compliance may require new systems and improved data visibility. Today, feasible solutions are available to drive excellence in manufacturing performance through better manufacturing intelligence and integration. Download this white paper to learn about Real-time Performance Management solutions. After completing the registration form you will have access to download the white paper.

Implementing the Electronic Labeling Submission Standard

New technologies for the electronic processing, communication and management of labeling, based on the Structured Product Labeling (SPL) standard, are streamlining the U.S. Food and Drug Administration's (FDA) handling of information. All manufacturers subject to the FDA's regulatory specifications for electronic submissions must adhere to SPL requirements. FDA regulated industries, such as pharmaceutical, medical device and other Life Sciences, are facing significant changes in how they report key information to the FDA in order to comply with this new standard. SPL is the XML document markup standard for labeling content adopted by the FDA. SPL replaces the previous standard for electronic submissions, which was based on the document centric Portable Document Format (PDF) standard. The adoption of the SPL labeling format has escalated the need for organizations throughout the Life Sciences industry to develop a new strategy for regulatory submissions. Efficient SPL implementation requires an enterprise-wide packaging strategy encompassing labels, packages and marketing materials. This paper provides a comprehensive overview of business and technical topics that can help you successfully implement SPL guidelines.

Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness

The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States' FDA. Design and development of PANalytical systems is done according to ISO9001:2000, ISO14001:1996 and CMM level 3 certified processes and procedures. These formalized processes and procedures include standards for all aspects of the development process, used in each project and safeguarded by PANalytical's quality control organization.

Pharmaceuticals Out of Balance

With budgets rising and sales flattening, have we reached a tipping point? This paper by ATKearney outlines the choice that drug companies face—whether to play in ever-smaller niches or reassert their position as key partners in improving global healthcare outcomes—as well as how they can transform themselves.

Is FDA's Process Validation Guidance as Simple as 1, 2, 3?

Peter Watler, PhD, of Hyde Engineering + Consulting answers industry's questions about the new guidance, and wonders whether it will set the stage for continuous improvement.