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
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
From QSR to QMSR
From QSR to QMSR On February 23, 2022, FDA will adopt the current QSR (Quality System Regulations: 21CFR Part 820
Differences between ISO 13485:2016 and the draft QMSR
The requirements of the current Part 820 are substantially the same as the requirements of ISO 13485:2016 as a whole.
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
