Five-Step “Cure” for Data Quality
Want a clean bill of health for your manufacturing and R&D data? Keep it on a regimen of simplicity, says Daniel Lebeau, vice president of management and information systems at GlaxoSmithKline Biologicals.
Lebeau, the chief information manager for the pharmaceutical giant’s vaccine division, says the best way he’s found to manage growth and regulation is through quickly implemented projects with clear, limited scope. GlaxoSmithKline registered $7 billion in vaccine sales last year, and owns about one-quarter of global market.
“I remember when I started [in 2001], we probably were about four or fives times smaller, so just imagine that the sales are doubling every three to four years. [That means] IT has a lot of impact” on growth, said Lebeau during a recent interview.
From his headquarters in Belgium, Lebeau and his team at GSK rolled out a single ERP software solution for all manufacturing, finance, procurements and human resources worldwide in just over half a year. Adjacent to that effort was a centrally owned data warehouse for the more than 14 manufacturing sites located across national borders, oceans and language barriers, so that vaccine information could “run as a single factory.” Also, Lebeau created a central data model for status and product tracking as required by the U.S. FDA. The same data model is fit for comparable regulations in Canada, Singapore, France and Germany.
Lebeau was selected as one of Information Management’s “25 Top Information Managers for 2011.” For a slide show of all of the honorees, click here.
The sum of parts making up the program grew from Lebeau’s own background and experience, split between academic research, doctorate work and a decade of experience managing IT manufacturing operations with Kraft Foods.
“Manufacturing understands control, they understand constraints, but [in] research, there’s more freedom, it’s about creativity. Basically, the IT is completely different,” Lebeau says.
To bring manufacturing and research together – across global locations and across varying governance requirements, no less – Lebeau says he channels data management through five steps he revisits to serve multiple cultures in the organization:
- Simplification: To sidestep IT fragmentation, move projects ahead with less technology, but stronger support for the defined amount of technology.
- Integration: Limit varying interface and data entry points for end users that, when multiplied, can put an entire data framework into turmoil.
- Impact: Rely heavily on testing before data programs go live, and ratchet tinkering during the initial implementation. Lebeau says this keeps long-term maintenance and troubles at a minimum.
- Optimization: Manage and upgrade assets to their full potential value across lines and departments: “Instead of speaking [about] portfolio management, it’s really speaking about asset management and trying to optimize as much as possible all of the potential, all of the software you have.”
- Quality: Clean and accurate data rules the day, even if that means delaying project delivery. The six-month projects favored by Lebeau are less negatively impacted by this requirement than would be a one-to-two year effort or one that is more comprehensive, he says.
For his next series of projects at GSK, Lebeau says he and his team of more than 100 will create a new, company-wide GRC platform and set of tools for audit management, control monitoring, continuity and the management of deviation of pharmaceuticals. Some of the tooling for this fall under what the pharma industry calls the “management of deviation” – think corrective and preventive action, and continuity measures – to stay abreast and compliant with the many worldwide regulations that move lock-step with vaccines, particularly in the U.S. and Europe. Once again, Lebeau will strive to keep a simplified approach through his five-tiered process and finish individual projects in around seven months to keep initial rollouts from getting out of hand.
In support of his framework and industry requirements, Lebeau says cloud computing is already showing promise for cutting the cost of his annual hardware expenses. With more software and services following trends of lower cost and simplification, there will be more opportunity to streamline processes that improve data quality and help integrate his portfolio of assets.
“Now, as a total, top-end benefit, there are many economists who still doubt that IT provides value. I think that with these IT costs of hardware and software decreasing … we will see the full power of IT in the coming years,” Lebeau says.