Pharmaceutical manufacturing faces IT crisis

Poor business processes and a "clumsy" approach to IT have contributed to the crisis gripping Australia's embattled pharmaceutical manufacturing industry.

Audits by federal regulators in the past six months have revealed grave safety and quality breaches that have been attributed to dismal manufacturing and management practices and exposed an industry unable to track, manage and audit business processes.

These are all problems in which IT plays a starring role and the fallout has ranged from the infamous Pan Pharmaceuticals' case earlier this year to a manufacturing ban introduced earlier this month at Australian Pharmaceutical Industries (API).

But according to Meta Group's vice president of technology research services, John Brand, it is a sophisticated and mature industry in terms of technology buying.

"The technology is up to date but it isn't being utilised successfully; the right business processes are not in place; but this has a lot to do with a lack of support by management," he said.

"Executives are far too aggressive when it comes to tradeoffs and making compromises in a bid to manage commercial realities. This is one vertical that spends less on areas like training and cultural change than they should."

Brand has also seen a lot of "clumsy"implementations because system integrators are caught between a rock and a hard place.

"Regulated industries don't often do implementations in-house, they use system integrators who do the best job they can under difficult circumstances. This is because document management solutions implemented in the past five years didn't provide a lot of ability to integrate with workflow applications; the technology has only improved in the past two years," he said.

"Although the software has improved organisations still have legacy systems in place they would need to upgrade, so it is an inter-dependency issue; this industry tends to put off painful issues."

In the wake of the fallout, federal watchdog the Therapeutic Goods Administration (TGA) has recognised the need to change its own operations and the Federal Parliamentary Health Secretary Trish Worth has flagged new legislation to strengthen TGA's powers.

Australian Consumers Association (ACA) health policy officer Martyn Goddard said the Pan fiasco was such a disaster that the TGA found it could no longer rely on its old methods, such as paper audits, which gave companies control over information they provided.

Now the watchdog will be looking to electronic records with IT systems coming under the microscope.

Enterprise content management (ECM) provider Documentum has a number of high-profile pharmaceutical customers in Australia including Mayne Pharmaceuticals and Johnson & Johnson. In the past two years alone local revenues have increased 200 per cent, according to the company's managing director Graham Pullen.

He believes no licences would have been suspended if the companies had used an effective ECM platform as regulated industries need to have business processes in place that can face an audit at anytime.

"However, in most organisations 80 per cent of content is unstructured and doesn't fit into rows or columns in a database; the outfall we have seen from this proves there is a need to overhaul IT systems, or companies face losing millions in revenue and damages," he said.

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More about ACAAustralian Pharmaceutical IndustriesAustralian Pharmaceutical IndustriesDocumentumMeta GroupPAN PHARMACEUTICALSTechnology Research

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