Going Mobile

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, and distribution.

Photo: SYCLO

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).

Figure 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 managers.

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 points.

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.

Pharmaceutical firms are also tapping mobile technologies to help their sales force focus on selling and to place products into customers' hands. Most sales professionals use automation systems to make sure they have relevant, accurate, and timely information, wherever they are. Pharmaceutical firms also strictly adhere to all 21 CFR Part 11 and PDMA guidelines for electronic record management, sample distribution, signature capture, and inventory management. For example, each professional's eligibility to receive samples based on state license validation status should be clearly indicated and enforced by the mobile software throughout the sales process. Overall, mobile technology makes efficiency and success possible in many operations within the pharmaceutical organization.

Figure 2

Seven reasons pharmaceutical enterprises are going mobile

1. Extending efficiency. Pharmaceutical companies turn to mobile technology to automate routine but critical facilities functions such as safety checks, security rounds, and information technology asset management. An employee equipped with a handheld device featuring the latest mobile technology can instantly report the operating status of an asset after a visual inspection. Should the equipment require repair or replacement, the worker can create a work ticket on the spot and immediately file it in a data back-end system for quick retrieval by management. Many pharmaceutical companies believe that they can increase the exchange of better-quality data between workers on the plant floor, warehouse, or other locations with mobile technologies. Employees receive timely and more accurate data feeds into their system and provide critical information to technicians and other workers using handheld computers at the point of performance, thus improving productivity through an accurate, timely exchange that is not always possible via cell phones or other modes of communication.

Mobile technology deployments also eliminate the need for technicians to spend valuable time on end-of-shift data entry, which translates into more time for asset repair and preventive maintenance programs.

2. Staying on top of all processes. Mobile technology helps companies ensure that laboratories, cleanrooms, and other production facilities are up to par. Cleanroom and laboratory inspections, live animal checks, and other monitoring functions required by FDA can be completed expediently and effectively when scientists and technicians instantly capture vital condition data with mobile technology. In addition, hours saved on such inspections result in more time for technical employees to devote to research, product development, and production processes or other important responsibilities that are directly related to production and compliance.

3. Supplying real-time information. A key reason pharmaceutical companies consider adopting mobile technology is the technology's ability to organize disparate functions into a unified process. For example, the supply chain operation at a typical pharmaceutical company has many steps that mobile technology can optimize and streamline by processing key data in real time.

The supply-chain operation involves receiving items such as raw materials or regulated chemicals, warehousing them, and eventually using them in production or another activity. In a paper-based system, a written record must be collected at each step of this process. A mobile system, however, enables managers to track goods received at their facilities with more accuracy and speed, without requiring them to review a paper trail to stay on top of shipments. Mobile technology also improves tracking during the course of the life cycle of materials, from the time they are ordered through the time they are received. Better tracking leads to more effective consignment stock and trunk inventory management, better compliance reporting, and enhanced safety measures.

Other areas of the organization benefit from real-time data collection, including customer service and satisfaction monitoring, partner and vendor support, cooperation among business units from production to distribution, sales, and service.

4. Improving sales, distribution, and customer service. Mobile technology allows pharmaceutical companies to streamline supplier–vendor contract management, and enable efficient and accurate stock management from the dock to the storage bins. This streamlined workflow, in turn, improves distribution, order fulfillment, and tracking. For example, with a mobile technology-enabled process, a firm can keep track of the drug samples its sales representatives distribute, which provides vital information for sales, marketing, and compliance-reporting purposes.

Companies reduce safety stock, stock-outs, and material shortages when workers can quickly track the location of items at any time. The progress of deliveries can be tracked through the data recorded by workers using handheld computers, which improves customer service.

Mobile technology also streamlines communication, which enhances inventory handling and management and reduces bottlenecks. Furthermore, mobile technology allows pharmaceutical companies to minimize their material handling labor and reduce inventory waste through shrinkage or spoilage.

In addition, mobile technology allows workers to capture real-time data on customer accounts and billing, purchase-order receipt verification, and shipping manifest—all at the point of performance. Transaction and transportation costs are reduced, and pharmaceutical companies can extend some of their savings to partners and suppliers.

5. Mobile technology and 21 CFR Part 11 reviews. The presence of mobile technology in pharmaceutical manufacturing is supported by considerable research and an extensive exchange of information between the mobile providers and drugmakers.

Although FDA doesn't mandate the adoption of mobile technology in Guidance for Industry: Part 11, Electronic Signatures—Scope and Application , the agency strongly encourages aspects of it, such as electronic record-keeping and signature capture. With a tamper-proof electronic record that can be sent and received through mobile technology to any data back-end system, pharmaceutical companies have complete records they can quickly provide at any time for 21 CFR Part 11 reviews.

Mobile technology can help streamline record storage. The electronic records generated by mobile technology also enable management to stay abreast of production developments within their facilities and make the adjustments necessary to reduce their risk of being out of compliance.

An FDA team performing an inspection will find it helpful when electronic records can be immediately produced for the facility they are reviewing. As part of many of its inspections, FDA includes a review of a company's production records. Some of the most common compliance violations among pharmaceutical companies involve imperfect records.

6. The value of investing in mobile technology. The value of mobile technology is simple: it enables companies to do more for less expense. The technology lets companies execute key business processes more efficiently, with considerably less hassle than paper-based systems.

Mobile technologies enable companies to spend more time developing products, serving customers, repairing equipment, and communicating timely and accurate information about the supply chain, manufacturing, and sales. This efficiency improves decision-making and the bottom line. End-of-day data entry by field staff is eliminated. Incomplete or illegible records are replaced by a system that captures and uploads accurate and complete electronic data.

To keep production on schedule, companies use mobile technology to identify problems with equipment and to isolate potential failures before they occur. Adopters of mobile technology in the pharmaceutical industry find they can extend the life of key assets. Thus, mobile solutions give companies time to perform more planned work.

7. Evaluating the bottom-line benefits of mobile technologies. The efficiency and cost-effectiveness of mobile technology appears on companies' bottom lines in several ways. One pharmaceutical company, for example, found in a recent study that, with mobile technology in place, its cost for handling an individual work order decreased from $4.90 to $0.84 because it used fewer administrative resources and eliminated redundant data entry.

Mobile technology brings companies value because it makes processes run more effectively and assets last longer. These improvements effectively lower the total cost of the asset in question by as much as 30–50% in many cases and deliver a quantifiable and quick return on investment, sometimes in six months or less.

Mobile technology also facilitates a more strategic approach to the allocation of human capital. It allows managers to reduce unnecessary foot traffic by their technicians and have them available when assets require attention. Mobile technology helps refine inspection and production processes, and improvements are reflected in healthy cost savings.

Equipment uptime, of course, is crucial in the pharmaceutical industry, where production should be at full capacity, and downtime equals lost dollars. With the additional "wrench time" mobile technology enables, technicians can devote more of their schedules to preventive maintenance to keep assets in operation longer.

When companies end their dependence on paperwork, they typically experience productivity increases of 10–25% (2). They also see an improvement in first-time fix rates because their skill teams have more data at the point of performance. The labor savings and increase in productivity easily offset the initial investment costs.

Deploying multiple mobile products that use a single platform technology decreases application costs and results in exponential increases in data for better management.

Conclusion

In the pharmaceutical industry, the adoption of mobile technology is an ongoing trend. Organizations are adopting mobile technology to remain competitive. The seven reasons why mobile technology is taking off in the pharmaceutical industry are straightforward and time-tested. New uses for the technology continue to emerge as operational and organizational experts are exposed to the software and users see its convenience.

Richard W. Padula is president and chief executive officer of Syclo, 1721 Moon Lake Blvd., Suite 300, Hoffman Estates, IL 60169, tel. 847.230.3800, info@syclo.comwww.syclo.com.

References

1. C. Garritty and K. El Emam, "Who's Using PDAs? Estimates of PDA Use by Health Care Providers: A Systematic Review of Surveys," J. Med. Internet Res. 8 (2), e7 (2006).

2. Syclo, "Syclo Mobile Results Customer Survey" (Syclo, Hoffman Estates, IL, 2004).