For instance, the software should be Web-based as this allows users around the globe to connect to a centralized database without the need to install software on local PCs. A Web-based software system can be deployed more quickly than client server applications, and is more cost effective to maintain as there is no need to perform future client upgrades.
Another imperative characteristic is that the software is highly configurable to meet all business processes in one single system without needing to purchase, install, and validate numerous “modules.” A highly modular system allows an organization to determine and configure its own “modules” (record types) according to the processes they need to manage. It should not be the other way around.
Representatives from numerous pharmaceutical and device companies have pointed out time and again that flexibility is the key aspect of an enterprise compliance platform. The ability for the company to adapt the product to follow all processes including the ones that you don’t know about yet will save time and money in implementation, validation and ongoing maintenance as needs change. Essentially, the product must be “configurable.” A configurable system, by its definition, enables an organization to meet its specific business requirements without requiring code changes and without necessitating complex scripting or programming. The extent of flexibility is also important. Many tools have some level of configurability, but it begs the question how much, and is this enough to support enterprise needs?
Long term solutions are required to be scalable, and use a robust database management system that can handle the largest potential number of users. The solution should lend itself to high availability through use of standard load balancing software and be able to support a large number of simultaneous users across the company from various departments and business units. If the system will be used in multiple locations in different time zones, it must also support Universal Time Code (UTC), and have a facility to be translated into additional languages. It is advisable to evaluate how many companies are using the system in a similar fashion and at what scale. Solutions that are proven to be globally scalable pose far less risk than those that have yet to be proven to work at global proportions. Enterprise quality and compliance management systems should also support integration to other systems that are related to the processes you are managing. These typically include Laboratory Information Management (LIMS), Electronic Document Management (EDMS), Manufacturing Execution (MES) and Enterprise Resource Planning (ERP) systems.
The system must be accepted in the industry as 21 CFR Part 11 compliant. Since the regulation in its present form can be interpreted in numerous ways, (for example, the number of days required for password expiration,) the system must be configurable to allow the company to set the parameters in accordance with its own policies and procedures.
In addition to finding a great system, find a great partner. The vendor should have a well-established customer base in the regulated industries, with validated production installations similar in scope and size to your organization. If your organization is in an industry that is just now implementing systems like this, look to other industries that have faced similar challenges. For example, the food industry can benefit substantially from the pharmaceutical industry’s experience with implementing these types of solutions. While of course the two industries are different, there are many parallels with regard to management of quality and compliance related events. Looking ahead, compliance management will continue to be amongst our highest priorities. As with all challenges come opportunities to change our outlook and approach to managing our business. Technology, as we know from the past, is never far behind these new opportunities. Implementing a strategic platform as a standardized tool to manage compliance related events and actions can help an organization efficiently manage its portfolio of compliance issues in an extremely efficient manner. Once having this mind set, and implementing a tool that is capable of making this vision a reality, a company will be well equipped to manage its compliance needs now as well as in the future.
- Statutory Programs Compliance Monitoring. U.S. Environmental Protection Agency. http://www.epa.gov/compliance/monitoring/programs/index.html
Steven R. Cagle is vice president of marketing and product development for Sparta Systems Inc. (Holmdel, N.J). Reach him at 888-261-5948 or email@example.com.