Increasingly, pharmaceutical companies worldwide are recognizing the cost savings and efficiency increases of using mobile
technology to streamline operations, increase customer satisfaction, and improve top-line revenues. Companies can adopt mobile
technology throughout the entire spectrum of their business—from sales and customer service to research and discovery, manufacturing,
Mobile technologies help streamline business processes at all stages of the pharmaceutical life cycle. Many pharmaceutical
companies use mobile technology to eliminate paperwork, meet 21 CFR Part 11 and Prescription Drug Marketing Act (PDMA) guidelines, electronically capture signatures, streamline inspections,
enable accurate data capture, and meet other performance objectives.
At the start of the product life cycle, researchers must ensure their cleanrooms and laboratories meet compliance standards
for contamination control, health and safety, hazardous chemical handling, and documentation. Firms are using mobile technology
to enable paperless inspections that capture data on-site. Paperless inspections allow companies to take immediate action
and store information for compliance and management decisions.
More and more, companies are using mobile devices for electronic data capture in clinical trials. This capability gives firms
immediate access to trial data and allows them to monitor events, derive accurate data, perform instant validation, and reduce
data-entry time. A review of randomized controlled trials that compared data capture with handheld devices against paper methods
demonstrated that data quality and timeliness increased with the use of handheld devices. Subjects also preferred using the
handheld devices, and their convenience likely increased subjects' adherence to protocols (1).
As an effective way to meet US Food and Drug Administration requirements, pharmaceutical companies have incorporated the e-signature
and e-validation features of mobile technology applications into their production processes to create an unalterable, accurate
electronic trail of accountability for inspectors to review. Mobile technology enables companies to track temperatures, data
points, and inspection points to ensure a safe and secure work environment and to keep production on schedule.
Many pharmaceutical firms use mobile technologies to make thousands of measurements that are the basis of decisions that affect
drug quality. Calibrating instrumentation helps maintain product integrity throughout the production process. And to ensure
that strict regulatory compliance and adherence to quality specifications be maintained, technicians using handhelds can capture
production data. Mobile technology also makes calibration data easily accessible to others who must monitor it, such as plant
For these reasons, many pharmaceutical companies use handheld computers to ensure that measurement instruments are correctly
calibrated. One pharmaceutical manufacturer uses mobile technology to track equipment temperatures, data points, and inspection
Taking the platform approach.
A major reason that some companies are implementing mobile technology is that it allows the large-scale optimization of manufacturing
tasks (i.e., maximizing the time, capital, and equipment used and streamlining raw-material handling and production). One
pharmaceutical company, for example, labeled more than 8000 assets with barcodes that its technicians could track with its
mobile technology application. As a result, the company has increased the number of completed work orders for preventive maintenance,
and managers are better able to account for the work done on those assets. Such efficiency gains are not possible with a paper-based
system. Of course, a hurdle for most pharmaceutical companies is to validate data capture for 21 CFR Part 11 for compliance reporting. Mobile solutions can ensure that vital information is electronically captured to keep accurate
repair and operating records for regulatory agencies.