Life Sciences Firms List Compliance, Consolidation as Main Challenges

A recent survey of top life sciences organizations found that compliance issues and increased industry consolidation (via mergers and acquisitions) are the top challenges faced by companies in today's market. The survey pointed to the need to achieve compliance with worldwide regulatory standards as a major issue for organizations trying to maintain their competitive edge in global life sciences industries.

More than half of respondents to the survey, which was administered to professionals in the pharmaceutical, biotech, medical device, and blood/tissue industries, said that varying supply quality standards and differing mandates across countries or regions are the greatest obstacles to managing quality and compliance. Moreover, increasingly global supply chains and greater industry consolidation are causing companies to re-evaluate their current practices and adapt to the changing industry landscape. Three-quarters of respondents said that they work with more than four global suppliers, with growing numbers of suppliers posing potentially significant threats to supply quality when not managed properly.

Key findings of the survey also included:

  • The status quo is not sufficient. More than a third of those surveyed said they believe their quality management systems are not adequate to manage supply chain risks and promote safety, indicating that the status quo is not enough to manage increasingly complex supply chain issues in a growing and changing market.
  • IT preparation is critical. Almost half of respondents reported that their companies are not equipped to manage IT consolidation resulting from mergers and acquisitions, with more than one quarter expecting that these activities would have a negative effect on product quality and safety. Without adequate IT preparation, companies run the risk of damaging their brands and endangering consumers.
  • Quality-related risk must be prioritized. Nearly one third of respondents do not categorize supplier relationships based on the risks they pose to the organization, exposing companies to undue vulnerability and potential product quality issues.

"As global authorities strengthen regulatory requirements, and mergers and acquisitions continue to dominate life sciences industry headlines, companies require comprehensive quality systems that can manage these complexities and alleviate risk," said Mike Jovanis, vice president of product management at Sparta Systems Inc., the Holmdel, N.J.-based company that conducted the poll. "This survey reveals that quality systems and operations must be continuously re-evaluated as the supply chain becomes increasingly global and regulatory scrutiny increases."

Sparta Systems, a provider of enterprise quality management systems, has more than 15 years' experience in the industry and a widespread customer base in the life sciences and other highly regulated sectors.

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