In our latest article, we discusses the EU/US GMP Mutual Recognition Agreement (MRA) which will pave the way for exchanges of GMP inspection documents and usage of inspection.
The latest Medical Device posts live here. A review of the pending updates to ISO 13485:2016 and helps you determine if your organization is ready (or not).
The team at Medicare Compliance Solutions discuss how Prescription Drug Event (PDE) records are the official records used by the Centers for Medicare & Medicaid Services (CMS) for Part D revenue reconciliation, coverage gap discount payments, STAR measures, 1/3 financial audits, and CMS program audits.
Our latest clinical blog discuss the requirements that clinical operations teams have shared with UL about their eClinical Qualification system needs. Sponsors are seeking assurances that clinical site personnel have received GCP education, that they can carry out the protocol properly, and that they can properly perform operational tasks, such as EDC entries.
In our latest learning article, Karl Kapp discusses the temendous value of an LMS and how reports of the death of the LMS are greatly exaggerated.