PIC/S GMP Annex 11 Computerized System Revision
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 […]
【medical equipment】Risk Management Course Part 1.
What is risk? The word “risk” may seem simple, but it is interpreted in different ways by different people. Even
From QSR to QMSR
From QSR to QMSR On February 23, 2022, the FDA published a proposal to amend the current QSR (Quality System
FDA CSA Draft Guidance with Bilingual Translation
FDA Issues Draft CSA Guidance On September 13, 2022, the FDA released draft guidance “Computer Software Assurance for Production and
[Preliminary] FDA’s Draft CSA Guidance Issued on September 13, 2022.
FDA has released draft guidance, “Computer Software Assurance for Production and Quality System Software” (dated September 13, 2022.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
Importance of the skill map The purpose of the competence table is, and so on. In this article, I would
Quality culture and Data integrity
Today, companies in all industries are being questioned about their attitude toward quality.In pharmaceutical companies, it is important to establish
【translation into Japanese】FDA Part 820 QMSR(Quality Management System Regulation)revised plan
Part 820 – QUALITY MANAGEMENT SYSTEM REGULATION (Draft) Table of Contents Subpart A – General Provisions 820.1 Scope of Application. 820.3 Terminology820.5 [Reserved]820.7 Built-in
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FDA Publishes Proposed Revisions to QSRs
From QSR to QMSR (Quality Management Regulation) FDA intends to harmonize and modernize its quality system regulations for medical devices.
Are FDA inspectors good?
When the author witnessed an FDA inspection at a certain listed company, the president of the company asked the following
