Data and Systems Management

As part of a highly regulated industry, bio/pharmaceutical manufacturers are expected to maintain the highest level of quality in every facet of their operations. Software solutions have demonstrated significant benefits across a broad range of functional areas for many organizations. KR Karu, industry solution director at Sparta Systems, spoke with BioPharm International about the importance of having an enterprise quality management system and how it can help companies to optimize quality, ensure compliance, and reduce both costs and risk.

BioPharm: In your experience, what common challenges are companies facing to ensure safe and efficient delivery of their products to the market?

Karu: For years, pharmaceutical companies have done a good job in ensuring safe products are delivered to the market by executing GxP processes and maintaining well-defined quality units. Recently, globalization and the pharmaceutical industry's growing dependency on suppliers are challenging this long-standing "gold standard" of manufacturing. The company marketing a specific product may not have manufactured the product, and even if it did, the original source of ingredients used is not always traceable. Assuring that materials universally meet specifications is increasingly becoming a real challenge.

BioPharm: What gaps still exist across the industry in terms of data and systems management?

Karu: The industry is managing data in multiple and sometimes redundant systems as a result of organic growth as well as growth through mergers and acquisitions. There is rarely one source for necessary information. Organizations may have local or regional disconnected systems for processes that should be global. Most companies have core systems (e.g., enterprise resource planning [ERP], customer relationship management [CRM], and enterprise quality management solutions [EQMS]) that perform unique functions but are not connected to each other. Many times, data transfer between systems requires a person to copy data from one system and enter it into the other. This practice is not only inefficient but is also a potential bottleneck and can introduce variability of data.

KR Karu

BioPharm: Because companies manage multiple functional areas as well as various sites, quality control may not always be applied consistently. What problems arise in this type of situation and how can software solutions help to address these concerns?

Karu: We refer to this layered complexity as the three dimensions of quality. The first dimension is the core quality processes such as audits, deviations and corrective and preventive action (CAPA), complaints, and change management. The second dimension comes from having processes in different systems for each functional area of the business, and then you add the third dimension of geography, where there are different systems and processes in different regions and countries. In this complex environment, when a problem is identified in one area, it becomes difficult to communicate and correct the issue across the enterprise. Implementing an enterprise quality management system provides global visibility and transparency to problems and their solutions.

BioPharm: When recalls happen, investigations sometimes reveal that the company had the data contained in multiple systems to show there was a problem but was unable to access the data in a timely or efficient manner. What are some best practices for managing multiple systems effectively to help identify such potential risks?

Karu: Managing multiple systems is not a viable option because individuals will need to be cross-trained in each different system (and at times, need to be multilingual) and know how to map similar data that may be categorized or labeled differently. Implementing an enterprise-wide quality system with harmonized data allows an organization to perform comprehensive quality checks on batches and products prior to release to the market. Information that would become obvious in hindsight now becomes visible during the manufacturing process.

BioPharm: Along these lines, what steps have you seen the industry take or require?

Karu: Progressive pharmaceutical companies have realized that quality is an enterprise-wide initiative. They have set up a single global system for all quality processes following the same repeatable process for investigating events, evaluating risk, determining root cause, and taking actions. By doing this, they can correct a specific problem as well as prevent it from happening at any other location around the world where the same conditions exist. It also allows management to analyze, trend, and even predict quality issues.

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.