A director of quality from one medical device manufacturer cited that prior to implementing a global compliance management system it had 12 disconnected systems just for managing deviations, investigations, complaints and change controls. The company implemented an off-the-shelf software system as its platform for managing all compliance related issues. In addition to providing the much needed integration between the various applications, the company saved $5.6 million and is recognizing an on going return on investment of $300,000 per year.
A vice president of information services from another organization made a point to stress how much time his users were saving because of the natural integration flow of using the same software system. By utilizing a single software platform the organization cut cycle time by weeks just by having all information at hand. Further, by eliminating redundant data kept in multiple sources, the company avoided the risk of having different versions of the same information in two places, an issue for which it previously received an FDA warning letter.
Many professionals that have already taken the enterprise compliance platform route will advise careful consideration when choosing which system will best serve its vast and evolving needs. It is easy to become overwhelmed with one or two areas of pain. Implementing an enterprise quality and compliance platform requires that an organization looks at the bigger picture. The system must have certain attributes and qualities to meet long term needs and to scale to global proportions.
Where to Begin
A good place to start is by looking at what things the system needs to do from a functionality point of view.
A compliance management system must facilitate data capture for all conceivable record types, as many as required, in a structured format. It must have the ability to organize them according to pertinent qualifiers, and automate completion of work through a business process defined by your own organization. The process must follow the procedures of the organization and departments that use the software. All data and signatures should be captured electronically, and without paper, thereby replacing the need to have “documents” circulating for signature and review.
Automatic notification capabilities are also important. Notification facilitates efficient inter-departmental communications, enabling staff members to be informed of all meaningful events on a timely basis and in a consistent manner. A system that notifies users of critical events, achievement of mile stones or when work is required, will help to shorten cycle times.
An effective enterprise compliance system will prevent issues from slipping behind schedule by automatically escalating action items that are not following expected timelines. “Escalation” may be notifying someone, re-assigning work or creating an action item to document the deviation from the process. SOP enforcement is also important as it takes the human element out of the equation. For instance, by automatically calculating due dates the system can ensure they are set correctly based on issue classification or risk level. Additional benefit can be derived from the automatic scheduling of tasks and work assignments to appropriate individuals. All of these “business rules” should be determined based on validated, pre-determined conditions.
Finally the system must ensure that employees involved in the business process are able to find information quickly, and therefore the system should provide a reliable and easy-to-use mechanism for searching the database and retrieving required data. All information should be accessible on demand, and without delay.
Further, it is crucial that the system is able to provide this information in meaningful report formats, provide statistical analysis, trending views, and the “big picture” of where the organization stands with its quality related processes.
Don’t Forget Scalability
Functionality is only the beginning when defining the qualities needed to implement an enterprise compliance platform. There are higher level fundamentals and without these, a system will not be scalable enough to support the organization at a global level.