6 Tips for Effective Quality Systems


The life sciences industry is undergoing a fundamental shift.

The FDA and other regulatory bodies want drug and device manufactures to go beyond ensuring compliance and focus on product quality, operational efficiency, and patient safety. Many new regulations and guidance require that manufacturers make substantial changes to their quality systems, data management and submission processes.

Read How Evolving Regulatory Pressure Will Impact Emerging Life Science Companies to learn:
  • Why the life sciences industry must emphasize quality over mere compliance
  • Current and emerging guidelines and regulations aimed at improving medical device and pharmaceutical product quality
  • The challenges posed to mid-sized and emerging life sciences manufacturers
  • Why companies should act quickly to align to these upcoming guidelines and regulations.

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Tom Middleton

Solutions Architect

Sparta Systems

Over the course of twenty years, Tom Middleton has conducted nearly 1,000 registration, surveillance, internal and supplier audits. Formerly an ASQ / RAB accredited ISO and Global cGMP lead compliance auditor for Underwriter’s Laboratories and Bausch + Lomb’s Surgical Division. He is currently an ASQ certified biomedical auditor.

Mike Edwards

Senior Product Manager

Sparta Systems

Mike Edwards is the product owner for TrackWise, the global leader in enterprise quality management. He has worked for Sparta for eight years and has been involved in the FDA Quality Metrics initiative for several years.

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