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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postpon [...]
Supplier Quality Management: A New QMS-Based Approach
According to research firm LNS Research, fewer than 1 in 5 companies have a robust supplier quality management process. [...]
Elements of an Effective Supplier Scorecard
Imagine if your plant is starting work on a big order. You’ve just been advised that a supplier has placed a key materia [...]
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, with manufacturing orders reaching a thr [...]
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the assumption that they must document and [...]
Automating Asset Change Management for NERC CIP-010 R1: Webinar
Compliance with evolving NERC CIP standards has become increasingly complex. In particular, CIP-010 R1 Asset Change Man [...]
