Issues related to long-term preservation of electronic records
Issues related to long-term preservation of electronic records 21 CFR Part 11 has a small number of requirements that are […]
Issues related to long-term preservation of electronic records 21 CFR Part 11 has a small number of requirements that are […]
From QSR to QMSR On February 23, 2022, FDA will adopt the current QSR (Quality System Regulations: 21CFR Part 820
The requirements of the current Part 820 are substantially the same as the requirements of ISO 13485:2016 as a whole.
Continuous improvement of data integrity and Article 20.2 of the GMP Ministerial Ordinance is a new article established by the
What is Digital Therapeutics (DTx)? Digital Therapeutics (DTx, or digital therapy), which utilizes apps and other software to treat, for
Action Limits and Alert Levels Action limits and alert levels are used, for example, as criteria to control microbial or
Why Data Integrity is Hard for Companies Interest in data integrity is growing.However, all companies are currently struggling to deal
What are the conditions for process validation? ISO 13485 7.5 Manufacturing and service provision 7.5.6 Process validation for manufacturing and
Pest Control Objectives In the course of his work, the author sometimes conducts audits of pharmaceutical plants and medical device
The Birth of the Validation Concept The idea of validation was inspired by the drug-related deaths caused by large-volume injectable