What is Quality Control?
<!–[CDATA[ What is Quality Control? As we explained last time, quality control is “a system of means for economically producing goods or services of quality that meet the customer’s requirements.”In other words, it controls the quality, cost, and delivery of goods and services provided to customers to meet their requirements.It is important that each workplace […]
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 comply with regulatory requirements and ISO 13485 with regard to complaint handling. The definition of a complaint in ISO 13485:2016 is as follows. 3.4 ComplaintsWritten, electronic or oral communication that alleges deficiencies related to the […]
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 for 150,000 yen. What would you think if you went home and saw that the buckle was a little dirty? You would think, “The quality is poor. On the other hand, suppose you bought a […]
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 need to follow ISO/IEC Guide 51 “Safety Aspects – Guidelines for implementation in standards”, jointly developed by ISO and IEC. The same applies to ISO 14971. In Guide 51, the “3-step method” is used. The […]
Importance of Communication
Importance of Communication It is important for the management to always keep emphasizing to the employees that they must comply with laws and regulations. Management’s attitude will enable a quick response to any problems or quality defects that are discovered, and will also create a sense of legal compliance among employees. On the other hand, […]
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 other words, they mistakenly believe that data integrity is a guarantee of reliability for electronic records. The principle of data integrity is equally imposed on both electronic and paper records. Here is a question for […]
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 achieve paperless “Electronic Signatures” at the request of the U.S. pharmaceutical industry to make paperless a reality.Since Part 11 was published on March 20, 1997, it has never Not revised.However, in the ever-evolving world of […]
Open Systems
Open Systems. In 1997, the FDA implemented 21 CFR Part 11 “Electronic Records and Electronic Signatures”Closed systems are those that exist inside a network that is within a company’s control, such as a LAN or intranet.Open systems, on the other hand, are those that entrust electronic records to a network that is outside the company’s […]
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 made cybersecurity measures mandatory for companies that manufacture and sell medical devices that use the program.Specifically, a third paragraph will be added to Article 12, Considerations for Programmed Medical Devices, of the Basic Requirements Criteria, […]
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 technically extremely difficult to comply with.Long-term preservation of electronic records is another difficult issue to address. Importance of Audit Trails As we have pointed out many times in the past, such electronic records should not […]
