Life-sciences manufacturers spend hundreds of millions of dollars to gain regulatory approval for their new therapies and require significant returns just to break even. If one adds to that the strict guidelines manufacturers must follow to ensure quality production for each and every unit, it is apparent why manufacturing consistency is a business imperative.
When internal or external forces challenge production standards, related processes, specifications, or critical documentation, controls must be put in place to ensure that product quality is not compromised. According to the US Food and Drug Administration, "Change control is a complex process. Inadequate change control exposes a company to product liability actions, results in product recalls, causes internal confusion, and is a serious violation of the Quality System regulation" (1).Best practices, industry standards, and governmental regulation demand that companies ensure adequate control over change management. Change-control systems must ensure consistent procedures and informed decision-making by qualified individuals and ensure traceability back to the justification behind the change process itself.
To stave off any issues associated with production processes and procedures, systematic controls must be in place. Enterprise software systems can provide this level of management and control, improve productivity, reduce production costs, ensure compliance, and reduce risk.
These tightly integrated and comprehensive systems work to evaluate changes as well as manage, track, and record them to ensure product quality. They also provide the necessary level of automated communication to those people who are affected by the change, as well as those responsible for overall product quality.
The types of change that can trigger a change-control incident include:
Although some have, many life-sciences manufacturers have not invested in a change-control system using enterprise software programs. Instead, they may be using home-grown solutions, paper-based processes, or reconfiguring existing quality-control systems to serve as an effective change-control mechanism. In most cases, these solutions are inadequate and cannot provide the necessary level of functionality and checks and balances.
Evaluating change-control systems
Despite the many economic, productivity, and risk-reduction benefits associated with control programs, the vast and complex nature of change-control procedures has caused many companies to struggle with implementing a global change-management system. Many manufacturers instead use a collection of disparate manual systems, spreadsheets, and databases. These disconnected mechanisms can lead to duplicate data and effort, input errors, inconsistencies, and delays. When a change occurs to product specifications, production processes, or associated documentation, a company without a change-control system lacks a centralized system to ensure that adequate measures are undertaken and brought to fruition.
The most common change-control problems facing life-science companies are:
Enterprise-level change-control solutions
Enterprise-level software provides change-control solutions that meet these challenges and help organizations avoid risk. These solutions can help to improve efficiency, increase control, and reduce defects. A cohesive enterprise change-control program integrates with other components of the organization's information-technology infrastructure. This integration can include the company's existing quality-management systems, enterprise-resource-planning programs, equipment-inventory systems, manufacturing-execution systems, and other systems that retrieve and aggregate master data.
The most effective change-control systems should provide functionality for centralization, automation, and integration. In terms of centralization, a change-control system should:
In terms of automation, a change-control system should:
In terms of integration, a change-control system should:
Change control in life-sciences organizations is crucial in terms of risk, safety, and business performance. A centralized change-control solution will not only manage a business's entire change-control program effectively, efficiently, and according to industry standards on a global basis, it will also open up a collaborative and ubiquitous communications channel across the organization. When a change-control incident is initiated, the system will automatically notify all affected parties within the company and beyond to be on the lookout for related issues within their own departments that can disrupt production.
The right enterprise-level solution should provide a central repository for all change-control instances and must be flexible, customizable, and straightforward in administration and use. This approach will lead to change-control processes and procedures that do not slow production, halt workflow, or leave the organization open to liability and business challenges.
In the end, change-control systems not managed correctly can severely damage the company's bottom line, put customers at risk, and tarnish the brand. When implemented and managed successfully, however, a change-control program can improve the business, enhance production, and increase product quality.
1. FDA, "FDA Center for Devices and Radiological Health, Medical Device Quality Systems Manual," (FDA, Rockville, MD, Jan. 7, 1997), http://www.fda.gov/CDRH/qsr/09docnt.html, accessed June 30, 2008.
Matthew Kopecky is manager of solutions architecture at Sparta Systems.