2010 Posts

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

Guidelines for governance, risk and compliance (GRC) affect nearly every company in every industry today, with different areas of scrutiny in varying areas of operations. Regardless of industry, however, successful companies reach corporate accountability by proving to stakeholders that their business is reliable, compliant, and sustainable.  To achieve this, a unified GRC strategy that guides people, standardizes processes, and integrates technology to embed governance, risk, and compliance must be established. (more…)

Five Key Essentials for a Good Electronic Document Management System

Five Key Essentials for a Good Electronic Document Management System

Organizations need to accommodate continuous improvement activities, daily operations and change that correspond to document content – administering all these documents, making it accessible and keeping it current. Today’s regulated companies must track and manage all documents from different departments, plant locations, customers, vendors and regulatory agencies. To be competitive, a firm must automate its handling of documents with an effective electronic document management system (EDMS). EDMS is a set of products and services that lets users electronically store, locate, retrieve, share and track documents. (more…)

FDA tells Drug Makers, “Just the Facts, Ma’am”

FDA tells Drug Makers, “Just the Facts, Ma’am”

Beginning in March 2011, companies testing experimental drugs or medical products will be required to inform the FDA within 15 days about serious risks and adverse reactions that arise during clinical studies (FDA, Sept. 2010). This isn’t anything new … the FDA just wants to make it simpler. The final rule is a revision of a proposed rule that was issued in March 2003. Apparently, many companies were piling information on the FDA in droves, making it harder for the agency to sift through the data quagmire to find the necessary information. Wanna make it easier on yourself and the FDA? Think Electronic Regulatory Reporting.
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Risk Management: An Opportunity or a Challenge?

Risk Management: An Opportunity or a Challenge?

All organizations at some point face issues in their operational activities related to product complexity, organizational inefficiencies, supply chain management and outsourcing, as well as internal and external risk. A series of highly publicized blunders, from BP’s oil disaster and Toyota’s massive recalls, to the egg recall, along with regulatory mandates and more active involvement among shareholders, are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise. (more…)

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

One of the biggest challenges for pharmaceutical companies is to complete investigations and actions in a timely manner. In 2009, ICH Q10 adopted by the FDA as an industry guideline, names pharmaceutical Quality Management Systems as a necessity to detect and evaluate non-conformances and take respective corrective and preventative actions. Although it takes time, an efficient CAPA process is an effective tool that can significantly improve quality systems and processes. (more…)

The Increasing Need for Quality Medical Devices is Matched by the Need for Compliance with ISO 13485:2003

The Increasing Need for Quality Medical Devices is Matched by the Need for Compliance with ISO 13485:2003

In October 2010, Medtronic agreed to pay $268 million to settle U.S. lawsuits and claims related to its Sprint Fidelis family of defibrillation leads recalled three years ago due to faulty wires. In 2009, the company estimated that at least 13 people may have died because of the problem. It’s situations such as this that emphasizes why standards have been put in place, such as ISO 13485: 2003, that help medical device companies maintain quality assurance and manage risk. (more…)

MHRA Looking for Quality Risk Management Systems — Sound Familiar?

The UK is on to something. British inspectors will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments when inspecting drug manufacturers. It seems both sides of the Atlantic are on board with quality risk management, and for good reason. (more…)

Get Lean! Using Six Sigma and Lean Strategies to Improve Quality

The goal of lean is to eliminate waste and non-value-added steps at all points in the manufacturing process. To accomplish this, lean implements continuous improvement practices and eliminating waste across the enterprise. Technology has been successful as key to achieving this end. While saving money might be an initial consideration with lean strategies, customer satisfaction is of utmost importance to any organization. By concentrating on customer satisfaction and value while eliminating waste, a company can build profits as well. (more…)

Moving Into the New Generation of 21 CFR Part II

Moving Into the New Generation of 21 CFR Part II

In 1997, it wasn’t uncommon to hear “You’ve got mail!” when you used your telephone to log onto the Internet. This is the same year that the Food and Drug Administration (FDA) issued 21 CFR Part 11, electronic records. Six years later, in 2003, you were probably using broadband and going directly to the Internet. In this year, the FDA issued a Guidance for Industry of Part 11, Electronic Records; Electronic Signatures. It shouldn’t be any surprise that seven years later, the FDA is piping up about Part 11 again. This time, it is in the form of revised enforcement discretion of Part 11.  (more…)

Quality and Safety Systems Need to Break Out of their Shells

Quality and Safety Systems Need to Break Out of their Shells

The Senate reconvened this month with a very important bill on its plate – the Food Safety Modernization Act (S. 510). With the recall of more than 550 million eggs and over 1,500 people sickened from salmonella fresh on their minds, this bill couldn’t be served up at a better time. Many of the backers of this bill feel strongly that this could have prevented or at least minimized the outbreak, and are hopeful that it will “solve” all potential future outbreaks. However, the 483 violations found at the two facilities were mostly facility-focused and clear violations of the Salmonella Prevention Plan. While the FDA has focused on the state of the facility’s environment, where is the focus on the quality and safety systems that are supposed to be in place at the company to prevent it from becoming a national crisis? As food safety issues continue to grow, regardless of whether S.510 is passed or not, manufacturers need to take control of their quality and safety issues in-house to prevent such disasters.  (more…)