“Quality & Compliance solutions help to improve products”

Quality & Compliance management is a growing concern among verticals such as automotive, pharmaceuticals, hi-tech and government. Shellye Archambeau, CEO, MetricStream Inc, spoke to AKHTAR PASHA about the importance of the speciality and the company’s plans for Indial

*Can you explain the importance of quality & compliance (Q&C) management for your customers in the hi-tech area?

Companies are spending 40 percent of their IT budgets on quality compliance, standards and regulations which are mandatory for their operations. From a CIO’s perspective, the problem is how to deal with new regulations or mandates, and to keep track of the same using systems to manage them. Customers use our Q&C solutions to help them manage their business and improve their products by providing real-time visibility to information and ensuring that proper notification and escalation occurs across the entire supply chain by including suppliers, customers, partners and the management in the process.

The solution also helps in reducing the cycle time for resolving issues and improving the efficiency of the people involved in the process. We track quality issues and corrective actions taken that are required to be monitored for regulatory and compliance purposes by governments. In particular, the FDA regulates industries such as pharmaceuticals, medical devices and biotech to track and provide full audit history around quality issues. Failure to comply can result in huge fines being imposed by the government. Keeping up with changing industry requirements—such as the ISO 9000 standards, and/or to implement/meet new industry or regulatory requirements such as 21 CFR Part 11 or Sarbanes-Oxley—are some of the big challenges.

For example, Hitachi Computer Products (Americas) Inc. was facing problems with its homegrown legacy solution; they replaced it with a new quality management solution from MetricStream. One such problem was that changes in ISO 9000 required extensive rework to upgrade their legacy solution with the required functionality.

*What are the current trends in Q&C?

The market is driven by industries such as hi-tech (increased focus on outsourced manufacturing), automotive (increased focus on supplier quality management) and life sciences (a consistent approach to implementing FDA regulations across all operations).

There are three important trends in the market. Companies are moving towards standardising their compliance solution on an enterprise-class platform rather than buying multiple-point solutions.

The number of regulations that an organisation has to comply with has increased dramatically over the years. For example, today, a typical global bank has to comply with about 370 regulators, a number that’s up 50 percent from a decade ago. With an increased focus on risk management, companies want to have a common system for regulatory compliance so they have the ability to see and manage overall risk.

A large number of companies are shifting their manufacturing and assembly operations to low-cost countries, or have outsourced these functions to a contract manufacturer in their own.

Similarly, companies are working more closely than ever before with their suppliers on design and manufacturing to compress time-to-market. It is important for such organisations to gain insight into quality metrics and issues at their supplier and offshore manufacturing sites so that they can prevent any unacceptable-quality products from entering the supply chain.

* What is the business potential for Q&C in India?

As investments in India by hi-tech, pharmaceutical, biotech and manufacturing companies continue to grow, these companies will have greater need for Q&C solutions. They are not only facing more regulations that demand compliance, but they are also part of a global organisation that requires adherence to standards to ensure quality products. Today, 12 percent of our Web inquiries come from India. To address this demand we will partner India-based companies which bring experience of the Indian market that we can combine with our industry and application depth to offer complete solutions. Our experience in working with global companies such as Pfizer, Hitachi and Subway positions us to help India-based companies.

*Can you give us some details on the kind of work being carried out of Bangalore?

We have 45 people in our development centre at Bangalore that has played a significant role in developing our Quality Stream solution. We offer self-support for our customers, and also carry out our finance, administration and entire back-office operations from here. What’s more, we are planning to double our workforce by mid-2005.