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
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
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.