Pharmaceutical Industry & Quality System Process Management

By: Marci Lynn Crane

A nail is driven out by another nail. Habit is overcome by habit.

----Desiderius Erasmus

In an age when life science companies stand to make millions or billions of dollars each year, making products that are safe and effective is a matter of "Do-or-Die" business. Luckily many compliance and quality driven processes are now matters of course within regulated life science environments. Life science companies know how to produce and they know how to control their output. Life science companies simply know what works and they stick to it. Like most of us however life science companies are subject to the fact that habits---when left unchanged---have a nasty way of turning the tables on good fortune. The good news however is that new habits once implemented often maintain the balance that everyone---and every business (including life science companies)---want to maintain.

The Quality System Habit

For some life science companies one of the most difficult habits to dispense with is the manner in which quality systems are controlled. Quality systems (i.e. document control, deviations control, nonconformance, equipment calibration, equipment maintenance orders, audit, CAPA, change control, training and the overall functions and philosophy that control product outputs) are often controlled manually or with a hybrid system. Quality system documentation for example, though it is the lifeblood of a quality system and is required by most regulatory organizations (FDA, ISO, CLIA, etc.), it is often routed, viewed, approved and archived using paper-based or hybrid systems. These manual or hybrid processes greatly slow the pace of a product to market and literally cost many life science companies hundreds of thousands or even millions of dollars for every day a product is delayed. In addition, employees who undertake these manual processes are also being paid for tedious tasks when their time could be put to better use.

The Technology Habit

Take a look at enterprise history. Those companies that implement the right technology at the right time are those companies that effectively streamline and catalyze their processes and their ROI. Life science companies need to make a habit of looking for new technology habits, especially for those technologies that are subject to continual development. For pharmaceutical companies for example the time is especially ripe for new quality system technological solutions. Many pharmaceutical companies are performing better than ever. Business is booming, opportunity has blossomed and pharmaceutical companies have the funds they need to invest in solutions that can help them greatly speed the product-to-market process. Even if a product goes to market only three months earlier than it would have with manual process management, pharmaceutical companies still stand to gain---with the help of automated quality system solutions---around a million dollars a day for every business day during those three months. In addition, an automated quality system that provides analytical and reporting features makes deviations and nonconformance data far easier to analyze, and with streamlined connections deviations and nonconformance data can be configured to trigger results from CAPA, http://mastercontrol.com/solutions/change_control_fb.html"">change control or training solutions. Furthermore, quality system solutions that make communication simpler such as web-based solutions that allow for collaboration are especially valuable as are solutions that provide audit trails for documentation and all quality system related processes. The call is out for pharmaceutical companies and life science companies to consider the new habits that quality system technology can present.

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