Improving Data and Content Migration Testing

In our previous article we outlined the nature of risks faced by regulated companies undertaking data migrations. We also gave some ideas on how that risk needs to be addressed and mitigated, primarily through the implementation of an appropriate and effective testing strategy. This article aims to continue that discussion and elaborate on what makes an appropriate and effective testing strategy for your particular environment.

ISO Standards: Quality Objectives and Quality Dreams

Author's Note: This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. The author suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. This article also illustrates ineffectiveness that results from vague and poorly defined quality objectives, and demonstrates how well-structured and documented quality objectives

Is There a Legal Requirement to Have SOPs for GCP in Europe?

Before addressing whether there's a European requirement for Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP), we need to consider whether ICH GCP (i.e. as provided by the International Conference on Harmonisation) remains the international standard following the publication of the Clinical Trials Directive (2001/20/EC) and the GCP Directive (2005/28/EC). Why? Mainly because the Clinical Trials Directive did not explicitly mention ICH GCP, leading to the perennial question o

GxP Lifeline - Medical Device Newsletter

The GxP Lifeline Medical Device consists of general feature stories, additional articles, a list of conferences, trade shows, and other events for life science professionals as well as a monthly Did You Know piece. For each article, we also include links to related articles and websites.

Automating Document Control Processes to Comply with FDA and ISO Requirements

The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

Automating Training Control Processes to Comply with FDA and ISO Requirements

FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This article identifies the basis for the requirement and examines the associated challenges for meeting the requirement and the shortcomings that

Avoiding the CAPA Calamity

Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all tha

Tips for Avoiding Internal and External Supplier Problems

The signing of the historic healthcare reform legislation will have a significant impact on both the medical device and pharmaceutical industries. A significant increase in the number of individuals carrying health insurance will translate into a greater demand for medical devices and pharmaceuticals. While this will improve profitability for many companies, it will present challenges to manufacturing and quality managers tasked with finding ways to quickly increase production.

Why Baldrige Works

There's no doubt that the Baldrige Criteria drive excellent performance. Of course, the perennial question for any improvement approach is "What's the return on my investment?" Cargill, a $107 billion company that produces and markets food, agricultural, financial and industrial products and services, says Baldrige is a huge return on investment. Their divisions that use the Criteria achieve 130 percent of their earnings targets versus divisions not using the Criteria, who achieve about 82 perce

Biologic-Device Combination Products: Jurisdiction

More and more companies are developing combination products for many life-threatening and unmet medical needs. One area that holds much promise is the development of tissue engineered products which contain living cells or tissues combined with a device. As with any novel technology, questions regarding what the requirements will be by the regulators to obtain market approval is always an issue. This has been a changing dynamic in other parts of the world but the Food and Drug Administration

21 CFR Part 601 and Vaccine Approval

21 CFR Part 601 and Accelerated Vaccine Approval: Five Things You Need to Know21 CFR Part 601 Provides Basis for Accelerated Vaccine Approval

AABB Abstract Submission: Everything You Wanted to Know but Didn't Ask

The AABB Annual Meeting and TXPO, slated for October 24 - 27 in New Orleans, hosts many educational activities. Among these is the Abstract Poster session, an opportunity to share your research with others and possibly obtain preliminary publication for grant and funding purposes.

The AABB is Soliciting Public Comments From Blood/Biologics Industry

U.S. Biovigilance Network: Hemovigilance System

AABB, formerly the American Association of Blood Banks, and the Department of Health and Human Services have partnered to develop the U.S. Biovigilance Network. This network will, for the first time on a nationwide basis, collect and analyze data to identify trends and recommend best practices to reduce adverse reactions and incidents associated with blood transfusion and related biological therapies. Ultimately, the analyses of this data will enhance patient safety, make better use of blood and

Blood & Biologics Article - Preparing For EU Assessment

By Becky SeeDiscusses how a U.S. blood center should prepare for an EU inspection.A safe and adequate blood supply is essential to the practice of modern medicine. New advances, particularly in the area of automation, have enhanced both safety and blood availability on an international scale.  Sovereign countries formerly looked to their own citizens for their blood plasma needs; today, plasma is an international commodity and as such, its collection centers are assessed by European a

Tracking Blood Electronically Article

Blood centers have been using reliable and easy-to-scan barcodes to positively identify and track blood products for decades. Radio Frequency Identification (RFID) technology has been widely used in other industries with myriad applications for years. Marrying the two technologies for transfusion medicine can make it possible to "read" containers of blood simultaneously, reduce costs, streamline operations, and ultimately prevent mismatched blood at the point of transfusion. The addition of RFID

Blood Center Accreditation by CAP Can Boost FDA Compliance

FDA-regulated blood centers, clinical laboratories, and related establishments are under tremendous pressure to maintain the highest standards for blood and tissue quality.

Blood Center Accreditation by CAP Article

FDA-regulated blood centers, clinical laboratories, and related establishments are under tremendous pressure to maintain the highest standards for blood and tissue quality.

Conferees Seek Paths to Improving Blood Center IT Systems

Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems.

Blood Substitute's Effectiveness and Safety Addressed In Large Clinical Trial

A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells.Academic and industry researchers participated in a Phase III multi-center clinical trial and found that use of a blood substitute was relatively safe in patients under 80 years old who have a moderate need for transfusion, up to the equivalent of three units of regular blood.Published in the June edition of the Journal of Trauma® this study is the first