As the pharmaceutical industry becomes more globalized and companies expand their operations outside the United States, these
companies face increasing pressure to comply with differing global regulatory standards that govern operations in diverse
geographic locations. The proliferation of global manufacturing processes has led to a rise in internal and external forces
that can challenge production standards, related processes, specifications, or even critical documentation. To ensure that
product quality is not compromised as operations expand, companies implement controls throughout the organization to ensure
that changes are recognized and enforced across boundaries.
But 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 (QS) regulation" (1).
Best practices and industry standards, as well as governmental regulations, demand companies ensure adequate control over
change management. Change control must maintain consistent procedures and informed decision-making by qualified individuals
throughout the supply chain while ensuring traceability back to the justifications behind the change process itself. These
justifications can include changes to a batch record, documentation, new country-specific reporting regulations, equipment
updates, supplier-related system updates, and any number of other changes in the day-to-day manufacturing operation.
To stave off issues associated with production processes and procedures, systematic controls must be implemented. By integrating
these processes throughout the enterprise, companies can achieve a greater level of management and control, and can even improve
productivity, reduce production costs, ensure compliance, reduce risk, and more.
While some life-sciences manufacturers have already invested in enterprise-wide change control, many continue to operate with
different processes in place throughout each location in the supply chain. Without a holistic approach to change management,
manufacturing points in different regions become disconnected and out-of-sync, making compliance with differing regulatory
standards near-impossible. In most cases, pharmaceutical companies are simply unequipped to face complex audits in the disparate
countries where they maintain operations, and those that do automate change-control processes lack the necessary level of
functionality to enforce proper checks and balances.
Other common change-control issues that are prevalent among pharmaceutical companies include:
- Decentralization of change-control data
- Cumbersome processes that disrupt roduction and delay change-control resolution
- Inconsistent change-control solutions that result in compliance risks
- Inefficient and ineffective mechanisms for managing action items associated with change control
- Ineffective use of data for trending and reporting in order to understand how to avoid such problems in the future.
Essentially, drug companies that lack effective enterprise–wide change control are running blind in terms of production quality.
When a necessary change occurs to product specifications, production processes or associated documentation, for example, it
becomes near-impossible to ensure that adequate measures are undertaken throughout the organization. Instead, a company typically
has multiple, disparate systems providing little—if any—sharing of information to help avoid change control redundancy, properly
assess risk, avert production disruption, and maintain quality manufacturing.
Implementing a change-control program requires an investment in time and resources, with a project team assembled to handle
the integration of the solution with the existing system and standard operating procedures (SOPs). Also critical to a project's
success is cultivating a C-level champion within the organization who will ideally guide, approve, and understand the needs
of the project team at every step of the process. Because life-sciences companies are often beholden to many stakeholders—from
investors to consumers—they are often caught in a battle between serving the bottom line and implementing the solutions that
will ultimately improve product quality and consumer safety. Projects that have a C-level champion are more likely to succeed
because the team has a resource it can turn to that will understand any issues that arise during the process of implementing
the solution and serve as a go-between for the project manager and the remainder of the C-level team. Those projects that
begin without buy-in from this level of the organization are more likely doomed to failure.
When the team is assembled and a C-level champion is on board, the next step is to identify the right technologies that will
ensure change control across the globally distributed enterprise. Some enterprise-level software on the market today can provide
change-control solutions to meet these challenges and help organizations avoid risk. The solutions can also help to improve
efficiency, increase control, and reduce defects. Comprehensive systems institute a cohesive, enterprise change control program,
which integrates with other components of the organization's information technology (IT) infrastructure. This can include
the following systems: quality-management, enterprise resource planning, laboratory information management, equipment inventory,
manufacturing execution, and others that retrieve and aggregate master data.
Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and business performance,
and it cannot be shortchanged. Far too many individuals need to be involved in even a single change-control instance to have
this important business process managed by disparate systems throughout the supply chain. To effectively compete in the globalized
and diversely regulated life-sciences industry, manufacturers must dissolve the silos currently dividing their various business
functions and enable centralized change control that effectively facilitates the necessary processes. The right processes
will not only manage a business's entire change-control program effectively, efficiently, and according to industry standards
on a global basis, but will also open a collaborative and ubiquitous communications channel across the organization. When
a change-control incident is initiated, the system should 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.
In the end, change-control processes not managed correctly can severely damage a company's bottom line, put customers at risk,
and tarnish the brand. However, when implemented and managed successfully, a change-control program can improve the business,
automate compliance with increasingly strict global regulations, enhance product quality, and ultimately benefit the consumers
that the company serves.
Marina Aslanyan is vice-president of Solutions Delivery and Support at Sparta Systems, Holmdel, NJ, email@example.com
1. FDA, "Device Advice: Device Regulation and Guidance," Quality Systems Regulation section online at