A VAR's FDA Certification Lands A $500,000 Wireless Install

It is estimated that each day saved by a pharmaceutical company bringing a new drug to market is worth $1 million. Southern Graphics & Systems, Inc. is a VAR and software developer that specializes in helping pharmaceutical companies work more efficiently using RF (radio frequency) and bar code equipment.

One recent win for the VAR was a company that performs phase one clinical trial studies for drug manufacturers (drug testing occurs in four phases). The client was referred to Southern Graphics & Systems by another of the VAR's clients. The phase one clinical trial studies company needed a way to reduce errors associated with handwritten data collection processes. It also needed to reduce the time to generate, collect, and analyze data.

Through value-added distributor ScanSource, Southern Graphics & Systems purchased 25 Symbol 2846 RF handheld terminals and 9 Datamax I-4208 thermal printers. Additionally, the VAR purchased and installed a Cisco 1100 series AP (access point) to transmit data collected from the Symbol handheld terminals to a server where Southern Graphics & Systems' custom software application resided.

Pharmaceutical Testing Software Must Be FDA Compliant
"The solution required very little integration because it was a stand-alone system," says Stan Weaver, president of Southern Graphics & Systems. The bulk of the cost of the $500,000 solution came from the complexity of the software requirements and the requirement for FDA (Food and Drug Administration) certification. Specifically, Southern Graphics & Systems had to demonstrate compliance with 21 CFR (Code of Federal Regulations) part 11. Per the requirement, a VAR needs to prove to FDA auditors that its solution can electronically capture detailed product information and maintain comprehensive chain of custody audit. Achieving this certification requires creating detailed procedures that describe software code design, development, and modification. Additionally, detailed software and hardware installation, upgrade, and maintenance processes have to be created. The total time required for the software development and certification was 18 months.

Even though there have not been any ROI studies done since implementing the solution, the client has given Southern Graphics & Systems positive feedback on its improvement in data collection accuracy and time saved. The VAR's plan to generate additional revenue from this installation is to expand its software program to cover additional clinical trial phases, which have different data collection and reporting requirements.