Birth of the Validation Concept
The Birth of the Validation Concept The idea of validation was inspired by the drug-related deaths caused by large-volume injectable […]
The Birth of the Validation Concept The idea of validation was inspired by the drug-related deaths caused by large-volume injectable […]
Three principles of GMP The three principles of GMP are as follows These are well-known terms, but it is not
What is the Basic Requirements Criteria? What are the approval standards for medical devices? Approval criteria” means criteria for medical
Why is sashimi eaten at home not tasty? Have readers ever felt that the sashimi they eat for dinner at
PIC/S GMP Annex 11 Computerized System Revisions 2022年11月17日付でPIC/Sが「Konzeptpapier zur Überarbeitung von EU-PIC/S GMP Anhang 11 (computergestützte Systeme)」と題したNews Releaseを公表した。 It also
What is risk? The word “risk” may seem simple, but it is interpreted in different ways by different people. Even
From QSR to QMSR On February 23, 2022, the FDA published a proposal to amend the current QSR (Quality System
FDA Issues Draft CSA Guidance On September 13, 2022, the FDA released draft guidance “Computer Software Assurance for Production and
FDA has released draft guidance, “Computer Software Assurance for Production and Quality System Software” (dated September 13, 2022. CSA Guidance),
Importance of the skill map The purpose of the competence table is, and so on. In this article, I would