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.
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 managers.
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.