by Milan Bhalala

Real-time, interactive compliance dashboards--software that provides a simplified view of key metrics--have finally become a practical option for medical device manufacturers. For most of these companies, which must come to terms with numerous regulations and technicalities to determine best solutions, state-of-the-art dashboards can provide a cost-effective solution to compliance challenges.

Regulatory challenges
The U.S. Food and Drug Administration is concerned with how regulated industries monitor and manage manufacturing issues. Defects and deviations require timely assessment and reaction, and corrective and preventive actions must be done as quickly as possible to ensure patient safety. The following technological components are required to create an "ideal" solution to these requirements:

• Universal access to information. Compliance professionals might need to access defect data from one system, customer data from another, and supplier and cost information from yet another. They'll want to see all this in one place and perform analyses across different solutions from a single window.

• A simple, proactive presentation mechanism that shows only pertinent information at the appropriate time. Most organizations gather enough information. The problem is that it's often stored in information silos and can be difficult to access in the way users want. Poor accessibility also poses security issues, such as who does and doesn't have access to certain types of data. Sometimes the opposite is true: Access to data is so unregulated that the amount and type of information used by different groups differs significantly, and they consequently draw different conclusions from the same data.

• An integrated collaboration and response capability. This will ensure that the right actions occur in a timely manner and can be deployed from the same presentation layer. Organizations don't want employees reacting to inaccurate information. Similarly, employees shouldn't have to log onto multiple systems to get a job done. Users should be able to act on information directly within a compliance dashboard framework. This means that the dashboard should rest on a framework that allows users to make changes at any level of the organization. For example, if defects are increasing at a certain step, a user should be able to initiate a corrective and preventive action from the compliance dashboard. If field issues point toward a problem with a specific part on the production line, a user should be able to increase the stringency of the testing on that subassembly from the compliance dashboard.

Medical device manufacturers want cost-effective help in managing and accessing information when they need it. They also want a solution to compliance challenges that won't negatively affect their bottom lines, which means that they must be able to leverage existing technology expenditures.

Compliance dashboards 101
A compliance dashboard is a software solution that shows a simplified view of key metrics or performance indicators relevant to FDA compliance and product quality. These data can be hard, such as process metrics (e.g., temperature, weight and counters) or soft, such as complaints or returns. In either case, they're always relevant to an organization's compliance needs. Offering more than just a system overview, compliance dashboards' built-in interactivity lets users click or roll over an icon to drill down into data over a specific time.

A dashboard's purpose is to gather data and flag deviations so that organizations can expediently and transparently access areas of noncompliance and, more important, react to the information. Current compliance dashboards are capable of time-based analysis and not only offer real-time information but also provide manufacturers with the ability to take snapshots of historical information. Because today's compliance dashboards link directly to an information source rather than an off-line data warehouse, users can respond immediately to issues from the dashboard screen. If needed, they can also set up automated rules to respond to certain situations by issuing alerts or halting production. This is a revolutionary capability and can only be managed via a service-oriented architecture (SOA), which allows diverse software applications to communicate seamlessly with each other. Simply put, manufacturers can now leverage their dashboards to create composite applications configured to map to the needs of compliance personnel.

Immediate access to information means that, whether they're working on the shop floor or in an executive office, personnel can accurately determine where a problem has occurred, its root cause, and the most appropriate corrective and preventive actions to take--as well as the expenditures involved. A key function of today's compliance dashboards is to ensure connectivity to manufacturing and quality information, including defect trends, scrap and field issues, and returns. More important, dashboards can link those elements to the language of management and executives--i.e., dollars and cents--so that management can monitor the profitability of the organization's compliance efforts.

All compliance dashboards are not created equal
Compliance involves unique processes for any given company, and information is required from across the enterprise. There's no end-to-end, compliance-centric, process-based solution on the market today. However, an SOA allows manufacturers to build workflows right into their compliance dashboards, which in turn enables them to retrieve data as well as configure the system to react to the data retrieved.

Regulated companies need a system that monitors compliant and noncompliant processes, one that enables users to drill down into data for speedy remediation of deviations via an accessible, unified view. Only through efficient remediation can manufacturers meet the challenges of stringent and continually evolving regulatory requirements. The ability to access this information in real time means that manufacturers can operate proactively when developing risk-management strategies. However, because compliance must occur across multiple software systems, a framework is required to consolidate all pertinent information. Likewise, because compliance dashboards involve regulatory data such as FDA 21 CFR Part 11, validation is an integral part of the right framework.

This framework should facilitate collaboration between key personnel within the organization. To do this, an organization must create a manufacturing compliance framework to seamlessly connect its various applications, often across a global manufacturing operation. The framework should leverage current technology, such as Web services and security protocols, to ensure the most stringent compliance.

Because no single compliance solution exists, medical device manufacturers looking for an effective compliance dashboard need a framework that will allow them to tap into all their systems in a way that aligns with compliance. This will also involve presenting the information so that personnel in any department, whether it's quality control or finance, can easily understand it.

For example, one metric that could be useful is the total number of documented nonconformances by product line. A manufacturer would have to be able to drill down into the data to determine the cause of the problem. The necessary information might come from several systems, such as nonconformance, device history record and auditing. It's likely a user will pull pieces of information from various systems to make the comparisons and correlations necessary to understand the compliance issues, such as whether the product met the original specifications and if all the rules were followed. Ideally, these data from multiple systems should map back to the original engineering specification--and this should all happen from one simple compliance dashboard.

 E-mail and Web services
An organization could also design its compliance dashboard so that if the quality level at a particular step dips below point A, the system automatically sends an e-mail to relevant individuals requesting a root-cause action or an order to shut down production at that step.

How is it possible to gain such easy access to this type of information? This is where Web services come into play. These offer a standardized method for two or more systems to communicate with each other. Web services have standard messaging capabilities, but coupling them to a manufacturing compliance framework can improve them considerably. Together, the systems can do more than simply exchange information; an organization can create workflows incorporating all systems. Web services make it easy to connect multiple systems together. Organizations that have difficulty integrating old technology into a manufacturing compliance framework can circumvent connectivity problems using Web services and thus create the necessary workflows.

Security
Security protocols are important for any compliance dashboard and should incorporate two major features. First, organizations should ensure that the compliance dashboard has a security model that limits access according to job functions within the organization. Second, the dashboard should provide the means to audit whoever accessed any information and--more important--the individuals who took action on it. In a closed-loop environment where crucial regulatory decisions are made, it's important to know what actions were taken when and by whom, as well as the reasons behind those actions. Finally, security protocols should also document who added what information to the system.

The resulting risk-avoidance
framework provides the intelligence (such as statistical views of quality information and predefined metrics) and analytics required to make faster, more accurate decisions to help manufacturers achieve the most strategic value from their investments. Because a manufacturing compliance framework has workflow capability built into it, manufacturers can interact with it in ways that make the most sense for the organization.

Case study: leveraging compliance dashboards to improve process flow
Compliance dashboards and related technologies can provide many benefits for ongoing production, but a large pacemaker company found an elegant application in the area of new product introduction. The company decided to change directions because its new product introduction involved people and processes from across the organization.

Ensuring that processes are followed is something that regulatory personnel monitor carefully during any new product introduction. The system of record for new product introductions has always been the product life cycle management (PLM) system, which this particular organization had implemented in 1998. The process consists of ensuring that proper personnel review the initial design and follow strict approval processes for any engineering changes prior to releasing the design to production. However, this manufacturer found that important information such as production route approval, test steps of key subassemblies and field monitoring of early units didn't link seamlessly into the PLM.

However, since implementing its compliance dashboard, the manufacturer's key personnel receive timely alerts concerning new production routes and change notifications about each route since initial creation. Sign-off on new production steps now takes place in the compliance dashboard, and the route deploys automatically to the floor upon approval. Depending on individual roles, management can choose an early sample size of the production product (most choose 100-200) and put in place strict, specific monitoring rules. Any deviations in testing results, device history record completion, field monitoring results and early-adopter customer feedback simultaneously prompt actions from relevant personnel within the organization.

Usually, all analyses of the issues take place in the compliance dashboard and, although not necessary, all line stoppages or changes in testing requirements can occur through the framework as well. All of this occurs via a single interface, and the organization can leverage information from various systems such as its customer relationship management and manufacturing execution systems, thus minimizing additional training and information technology expenses commonly present in other types of deployments.

This Class-3 device manufacturer has found that it has much more confidence during the product launch process because it has the tools to analyze and act upon all key information. This, combined with removing the overhead from initial reviews, greatly reduced time-to-volume and exposure to compliance issues for the company.

Summary
Most software vendors will say that they have the best dashboard solution for compliance. Before considering the options, it's important for an organization to define its needs and know what it must do to be in compliance with current regulations. Only then should it start looking for a vendor that can help it achieve compliance control across the company's entire framework--and thus across the entire business infrastructure. As long as key components are there, processes will be compliant, and users will find it relatively simple to access any compliance-specific area. If approached with care, taking advantage of compliance dashboard technology can streamline an organization's compliance efforts.

About the author
Milan Bhalala joined Brooks Software, a division of Brooks Automation, in 2005, and is currently the director of life sciences. He was previously with Gambro BCT, the leading provider of automated collections equipment to the blood- banking industry. In his 10 years in the life sciences software industry, Bhalala has had various roles in engineering, finance and marketing. In 1999, he founded Atma Software, a leading provider of supplier management software, which was acquired by Agile Software in 2002. He holds the U.S. patent for multivariate supplier management. Bhalala has a bachelor's degree in chemical engineering and an MBA from Carnegie Mellon University.