Each system plays a part
Drugmakers often use dedicated software solutions to perform tasks such as maintenance, manufacturing, and analytical testing.
Each of these systems can play a part in reducing the deviations that might otherwise trigger a CAPA process. For example,
operations-management software uses automated workflows to walk personnel through standard operating procedures step by step,
thus ensuring that manufacturing steps are carried out correctly. The software also verifies that equipment has been cleaned
or sterilized and that personnel have the training required for a given procedure. By checking this information before performing
work and making it available to workers in real time, an operations-management application can help to prevent deviations
from happening, thus ensuring the manufacture of acceptable products and saving time that might have been spent on investigations.
Software from companies such as EtQ (New York) can prompt manufacturers to take corrective actions in response to deviations.
(IMAGE IS COURTESY OF ETQ)
A quality-management system (QMS) can confirm the identity, strength, and purity of raw materials and finished products. QMS
helps manufacturers maintain accountability by allowing them to assign employees the responsibility for investigating the
cause of a given deviation. The software also allows managers to establish a timeline for resolving deviations and to develop
a structured escalation process for overdue actions.
Companies have been successful in establishing QMS at a high level, but they often are cited for not implementing it or for
not having a uniform process for mitigating deviations, says Michael Sieve, life-sciences solutions engineer at Seapine Software.
With an effective CAPA procedure, aided by QMS, organizations can prevent recurring manufacturing failures, save time and
resources, and help generate revenue.
Unite and conquer
More and more, pharmaceutical companies are realizing that the information in their various data systems can improve CAPA
processes appreciably. During the past few years, manufacturers have begun to flow information from software such as QMS and
maintenance systems into their operations-management system. And links between companies' CAPA and operations-management systems
are becoming increasingly common, to the point where they are expected for new facilities.
"You're starting to see much more of an integration of information flows between what had been various silos," says Bob Lenich,
director of Emerson Process Management's Syncade product platform. If these data systems are linked, an excursion during production
automatically triggers a deviation process within a CAPA system. This link helps resolve the deviation faster and allows products
to ship sooner as part of the normal release process. Integrating information from laboratory, maintenance, and operations
systems is crucial, says Lenich, because it can help the CAPA process find the root cause of production problems early so
that they can be avoided.
The case for full conversion
Much of the pharmaceutical industry has automated various steps of the CAPA process such as requirement gathering, event tracking,
and testing. But full automation in CAPA is currently not widespread. Manufacturers ultimately need a single system that provides
full traceability of requirements through testing, defects, corrective action, and closure so that teams in successive segments
of a product's life cycle are informed about previous deviations and understand why particular events were resolved in certain
ways. "Being able to automatically inform people about the current status of a product can be invaluable in the long-term
life of the product," says Sieve.
Many companies believe that automating CAPA processes is expensive, time-consuming, and does not provide a return on investment.
But this belief is mistaken, says Sieve, because some vendors offer an all-encompassing automated CAPA system that is much
easier to set up than an enterprise resource planning system, which can require extensive customization. Commercial off-the-shelf
software can offer a wealth of configuration options.