Tim Postema’s default image

By: Tim Postema

The Dutch public health care system is being transformed in various ways. With an increasing focus on efficiency and consumer driven care, health institutions in The Netherlands are forced to critically evaluate their actions and processes. With recent political developments creating a more liberal health care system, the role of the patient is steadily changing to the one of a demanding consumer, taking more and more control of his or her own choice of care, all for the best price available. In that sense, health care services are forced to negotiate in a complex matrix of insurer, consumer and government, where good and structural quality of care plays a decisive role. But what exactly is quality of care? Who determines the value? Is it possible to create measurable attributes for quality of care?

The deliverance of accountable quality of care requires an operational and functional quality system. This system plays a key role in the evaluation and improvement (Deming’s plan-do-check-act) of process and outcome quality.

To gain an accurate insight in the different aspects of this system, the use of performance indicators can be a useful tool.

Marlo Brooke’s default image

By: Marlo Brooke

The groundswell of radio frequency identification devices (RFID) in health care may be clouded by the stomping of Wal-Mart, but the biotechnology and pharmaceutical industries are quietly becoming one of the top innovators and users of RFID, and they’ll likely outpace other market segments in the very near future. Stripped of its media hype, RFID is essentially a tracking device. One might wonder what the big deal is. With the never-ending effort of improving patient safety and cutting costs, health care is certainly well-aware of the need to track its every activity. In an industry mandated by federal, state, county and local regulations, tracking is nothing new.

And yet, RFID offers a powerful benefit over other tracking technologies such as bar coding or manual processes. RFID can automatically trace any medical device, pharmaceutical or patient over a given period of time.

Because RFID tags have reading and writing capability, as well as sensors, an RFID-equipped medicine or surgical instrument can indicate in real-time whether the item has been introduced to contaminants, when and where it has moved over time, and environmental conditions, such as temperature and humidity. As such, RFID enables what is called the four-dimensional supply chain.

Thomas Erbach, Lisa Fan and Shari Kraber’s default image

By: Thomas Erbach, Lisa Fan and Shari Kraber

Optimizing biological assay conditions is a demanding process that scientists face every day. The requirement is to develop high-quality, robust assays that work across a wide range of biological conditions. The demand is to do this within a short development time frame. To overcome these obstacles, automated systems are often required to accommodate large numbers of samples. Setting up a model that systematically studies key experimental parameters, each across a defined range, is a challenge. Traditionally, one-factor-at-a-time (OFAT) testing studies individual experimental conditions, but this approach is time-consuming and tedious. More important, measuring how the change of one single factor affects the assay leaves the experimenter blind to interactions that may exist between two or more experimental factors. The information lost in OFAT designs may significantly reduce assay quality and robustness.

Laura Smith’s picture

By: Laura Smith

In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical manufacturers have formed a coalition, SAFE-BioPharma, to support the widespread adoption of the new global digital identity standard, Secure Access for Everyone (SAFE).As the biopharmaceutical industry has become more automated, it’s also become more collaborative. Inter-agency relations are more important than ever, but automation makes maintaining such relationships a challenge. This situation creates the need for a standardized communications approach to e-signatures that is both secure and legally enforceable.

SAFE was introduced in June 2004 and includes policies, procedures, guidelines, technical specifications and a liability risk management framework for ensuring the validity and identity of authorized users. The network on which it operates was designed to assure member companies complete security while reducing the risks and costs associated with creating internal, legally enforceable digital signatures.

Tamar June’s picture

By: Tamar June

Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become clear that the agency is quite clear in what it expects from companies when it comes to the kind of records they need to keep and how long they should hold onto them.“The regulations are specific about record retention,” notes Keith Benze, a consultant and compliance expert with SEC Associates and a co-author of The ‘New’ Part 11 and Drug Development: A Q&A Reference Guide (Barnett International, 2004). The FDA focuses on maintaining records for a certain period of time after an event. “For example, one year past the expiration of date of drug products,” Benze adds.

In other cases, that period is usually a year or two after the last distribution of the product or approval for the IND.  For example, Part 11’s section 820.140 states, "All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer."

Tamar June’s picture

By: Tamar June

If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of your competitors at FDA-regulated firms, industry consultants and even FDA agents.“Any electronic record system that can’t comply today should not be in service,” states John McKenney, SEC Associates’ president and CEO. While speaking at a Drug Industry Association event in 2004, he stressed that with the exception of open and electronic signature systems, the controls required today by the FDA for Part 11 aren’t significantly different from the agency’s expectations for validated computer systems dating back to the late 1980s.

The cost-benefits of Part 11 compliance are difficult to break out as a separate line item on the budget, but the fact that they save companies time and money is self-evident. “I firmly believe that [Part 11’s] validation and data integrity controls are good business practices,” states Keith Benze from SEC Associates.

BSI’s picture

By: BSI

More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world. When Lavrovsky needed a new hip replacement in 2004, OTI was more than happy to donate everything that was needed for the operation to be a success. Ian Murray, CEO and chairman of OTI, smiles with pride when he recounts this story. It’s a reflection of the company’s commitment to the high standards in an industry in which perfection isn’t just a goal, it’s a daily requirement.

Mikhail Lavrovsky stated in his recent letter of thanks to the company: “Your great gift means life to me.” For those who require such complex and life-changing procedures, the last thing they want to worry about is the quality of the medical device being used. The implementation and rigorous assessment of internationally accepted standards are essential.

Tamar June’s picture

By: Tamar June

If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of your competitors at FDA-regulated firms, industry consultants and even FDA agents.“Any electronic record system that can’t comply today should not be in service,” states John McKenney, SEC Associates’ president and CEO. While speaking at a Drug Industry Association event in 2004, he stressed that with the exception of open and electronic signature systems, the controls required today by the FDA for Part 11 aren’t significantly different from the agency’s expectations for validated computer systems dating back to the late 1980s.

The cost-benefits of Part 11 compliance are difficult to break out as a separate line item on the budget, but the fact that they save companies time and money is self-evident. “I firmly believe that [Part 11’s] validation and data integrity controls are good business practices,” states Keith Benze from SEC Associates.

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