What is Quality Assurance?
What is Quality Assurance? QA stands for Quality Assurance. Often, there is a misconception that quality assurance is provided through […]
What is Quality Control?
<!–[CDATA[ What is Quality Control? As we explained last time, quality control is “a system of means for economically producing
Misconceptions of Complaint Management
Misconceptions of Complaint Management In the course of the author’s consultations and audits, he often sees cases of failure to
What is quality, good quality, and quality assurance?
What is quality, good quality, and quality assurance? 品質とは What is quality? For example, suppose you bought a brand-name bag
What is the 3-step method?
What is the 3-step method? There are numerous standards for risk management, both ancient and modern. However, all international standards
Importance of Communication
Importance of Communication It is important for the management to always keep emphasizing to the employees that they must comply
Is Security and Audit Trails Enough for Data Integrity?
Is Security and Audit Trails Enough for Data Integrity? Many people confuse data integrity with 21 CFR Part 11. In
Part 11 History and Trends
Teil 11 History and Trends 21 CFR Part 11 (“Part 11”), at the request of the U.S. pharmaceutical industry to
Open Systems
Open Systems. In 1997, the FDA implemented 21 CFR Part 11 “Electronic Records and Electronic Signatures”Closed systems are those that
Cyber security measures are essential.
Cyber security measures are essential. Effective April 1, 2023, cybersecurity measures will be included in the basic requirements standards.This has
