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Online File W4.12=20

SYSTEM FAILURE AT THE FDA=20

Failures of e-commerce systems should not seem surprising, since we = have=20 known about failures of EDI systems for more than 15 years. A typical = example=20 involved the attempt of the U. S. Food and Drug Administration (FDA) to = install=20 an online collaboration system to reduce drug-review time (Williams et = al.,=20 1997). It was basically an electronic submission system and then an=20 intranet-based internal distribution and review system. The system = failed for=20 various reasons. We present them in list form below; many of these = reasons are=20 typical of the reasons for EC failures in general, so we have = highlighted the=20 key words, for future reference.=20

No standards were established for submitted documents.=20

There was resistance to change to the new system, and the = FDA did=20 not force reviewers to work electronically.=20

The system was merely an electronic version of existing documents. = No=20 design was undertaken in planning (or improving) the new system.=20

The FDA lacked technical expertise in interorganizational=20 information systems and in collaborative commerce.=20

No training or even information was provided to the FDA=92s = end=20 users.=20

There were learning curve difficulties, and no time was = allowed to=20 learn different document systems.=20

Clients (the pharmaceutical companies) were not encouraged = to make=20 electronic submissions.=20

There was no IS planning. The FDA knew that a business = process=20 design study was needed, but did not do it.

However, the FDA learned from its mistakes. An improved EDI-based = system was=20 installed in 1998/1999=97after a BPR was done, training was completed, = and=20 standards were provided. The system became a full success in 1999.=20

SYSTEM FAILURE AT THE FDA=20

No standards were established for submitted documents.=20

There was resistance to change to the new system, and the = FDA did=20 not force reviewers to work electronically.=20

The system was merely an electronic version of existing documents. = No=20 design was undertaken in planning (or improving) the new system.=20

The FDA lacked technical expertise in interorganizational=20 information systems and in collaborative commerce.=20

No training or even information was provided to the FDA=92s = end=20 users.=20

There were learning curve difficulties, and no time was = allowed to=20 learn different document systems.=20

Clients (the pharmaceutical companies) were not encouraged = to make=20 electronic submissions.=20

There was no IS planning. The FDA knew that a business = process=20 design study was needed, but did not do it.

Clients (the pharmaceutical companies) were not encouraged = to make=20 electronic submissions.=20

There was no IS planning. The FDA knew that a business = process=20 design study was needed, but did not do it.

There was no IS planning. The FDA knew that a business = process=20 design study was needed, but did not do it.

However, the FDA learned from its mistakes. An improved EDI-based = system was=20 installed in 1998/1999=97after a BPR was done, training was completed, = and=20 standards were provided. The system became a full success in 1999.=20

References FOR ONLINE FILE W4.12=20

Williams, J., et al., =93IT Lessons Learned from FDA,=94 Failures = and Lessons=20 Learned in IT Management, 1(1), 1997.=20