BioPharm: Can you talk about the importance of change control?
Karu: Out of all of the quality processes, having a global and collaborative change-control system has significant impact on a company.
There have been documented cases where pharmaceutical manufacturers have made the same licensed product in multiple sites
but managed change with local change-control systems. In one extreme case, the product was unlicensed by regulators because
the production process underwent different changes in the two locations, and in effect, resulted in two different products.
Effectively managing change in a global change-control system prevents this type of scenario from happening.
Change control also involves multiple functional areas of the business and usually has multiple tasks associated with it.
An example is a labeling change. If the product is sold in multiple countries, you need to create tasks to communicate with
the various regulatory authorities and receive approval for the change. You may need to translate label content into multiple
languages and get approval that the change is the same. Furthermore, you may need to manage which authority has approved the
change and where you can ship the changed product. Performing these tasks in multiple systems can create a noncompliant situation
and result in lack of control over product and distribution.
BioPharm: How can a company minimize quality issues and recalls?
Karu: Having an enterprise-wide quality management system has had a dramatic and measurable positive effect on companies that have
adopted it as a global process. For example, one of the top 10 global pharmaceutical companies had a 70% reduction in quality
events within three years of going live with a single global system that enforces the same processes at more than 50 sites
worldwide. This organization attributes the 70% reduction to applying corrective actions, preventive actions, and change controls
globally when issues are detected. When a root cause of a problem is found, they not only correct it at the point of discovery,
but apply the correction at every site where the same equipment or manufacturing process is used. This 70% reduction in quality
events eliminated costs that were equivalent to more than 2% of the company's gross margin. Not only do they produce safer
products, but the system also saves the company a considerable amount of money.
BioPharm: What can an organization do to ensure that measures taken are scalable and secure enough to support thousands of users around
the globe? What can be done to increase awareness and equip staff with the appropriate knowledge and skills in this regard?
Karu: Implementing an enterprise quality management system is something that takes careful planning. Many systems work on a smaller
scale, but when thousands of users and millions of records need to be interacting in the system, many systems will be challenged
and will possibly fail.
When evaluating different systems, companies need to perform their due diligence with vendors being considered. That means
you need to ensure that the vendor has implemented and continues to support systems with thousands of users and the number
of records estimated to be created over a period of five or more years. Make sure the vendors can support a single instance
and are not tying together multiple databases, which can create points of failure. Unfortunately, in the software industry,
companies often will make claims about their system's capabilities and scalability without adequate testing or real-world
experience. Make sure your vendor has systems in place that are at least as large as you anticipate your fully built-out system
will be. Otherwise, be prepared to be this vendor's beta site with all the associated pain.
KR Karu is industry solution director at Sparta Systems, 2000 Waterview Drive, Suite 300, Hamilton, NJ 08691, USA.