"My impression is that most mid to large companies view automation as being required for CAPA," says Lenich. During a US Food
and Drug Administration audit, manufacturers are expected to show that they have a formal CAPA process, that they enforce
it, and that they record its history and metrics.
"An automated CAPA process, or at least a partially automated process, is vital for any mid-sized to large pharmaceutical
company," says Pfizer s Kentrup. Improved compliance, operational effectiveness, and continuous improvement are major reasons
that these companies invest in automation. Automated CAPA systems make a lot of sense for large facilities that manufacture
the same products consistently because they provide a standard infrastructure and enable manufacturing, investigations, remediations,
and trending to be carried out quickly and effectively.
An automated CAPA process is virtually a necessity for large organizations with multiple production facilities and many products,
says Lozier. To reduce time to market, meet customer demand, and maintain a high level of quality, Big Pharma uses automation
as much as possible to streamline its complex operations. Large companies must not only automate their processes, but also
seek ways to integrate manufacturing software with their other business systems, says Lozier.
CMOs can derive the same benefits from automation as pharmaceutical companies do, says Lozier. Some brand owners are enabling
CMOs to participate in their CAPA systems. "Using robust flexibility and security, contract manufacturers can participate
in the CAPA process without compromising the brand owners' system," says Lozier. This arrangement helps promote collaboration
between CMOs and brand owners while tracking quality and compliance throughout the supply chain.
Several large CMOs have invested in automated CAPA systems to help them keep track of multiple contracts and customers. An
automated CAPA process enables a CMO to improve its transparency and show clients that it is operating in a state of control.
Software also helps reduce the amount of time needed for routine oversight and quality audits. Another benefit for CMOs is
that a potential sponsor company might be more confident in a contractor that uses an automated CAPA system similar to the
one the sponsor uses in house, says Kentrup.
Automation advances onward
CAPA processes are becoming increasingly automated in every industry, but regulatory scrutiny makes automation all the more
important to the life-science industry. "The difference between an automated versus a manual CAPA process can mean a great
deal, especially if a company is being audited by the US Food and Drug Administration," says Lozier. Automated CAPA systems
help provide traceability and visibility, which are important to a successful audit. The more data a company can provide about
adverse events and corrective actions, the better it can demonstrate regulatory compliance.
Although automation can make a wealth of information available and greatly enhance process control, drug-makers should keep
in mind that it is an extension of a company's existing CAPA process, which begins with its personnel. "The key is to keep
the automated system simple—use it as a tool to drive the CAPA process, not as a solution to the process," says Lozier.
Effective automated solutions should be able to adapt to companies' existing CAPA processes and provide a way to streamline
them, thus making them easier for users, says Lozier. Software also should be flexible enough to adapt to changing processes
without requiring a burdensome amount of customization.
Software systems surely will become more common in drugmakers' CAPA systems, just as they have become integral to other operations.
Automation "is one of the most sought after features in any quality system, since it is the heart of the process and a catalyst
for change," says Lozier.