What is continuous improvement of DI?
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)?
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 Action limits and alert levels are used, for example, as criteria to control microbial or
Why Data Integrity is Hard for Companies
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?
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
Pest Control Objectives In the course of his work, the author sometimes conducts audits of pharmaceutical plants and medical device
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
Three principles of GMP
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 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?
Why is sashimi eaten at home not tasty? Have readers ever felt that the sashimi they eat for dinner at
