The US “Chapter 21 of the Code of Federal Regulations” Section 11 defines the standards for electronic data integrity established by the US Food and Drug Administration (FDA). Industries regulated by the U.S. Food and Drug Administration (FDA), such as medical device manufacturers and pharmaceutical companies, must comply with the provisions of Section 11 of 21 CFR to ensure the accuracy of electronic records and signatures.

However, it is difficult and time-consuming to comply with these requirements. This blog discusses common challenges encountered in meeting the requirements of Title 21 of the Code of Federal Regulations, Section 11, and discusses ways to resolve these challenges.Click here https://www.eleapsoftware.com/21-cfr-part-11/

Challenges encountered in meeting the requirements of Title 21 of the Code of Federal Regulations Section 11

The compliance process usually includes the creation of work description documents to make the work comply with each of the specific provisions in Section 11 of the 21 CFR; the development of verification protocols to ensure the correct setup, operation and performance of equipment and software; the creation of standard operations Procedures (SOP); conduct comprehensive training for personnel who use equipment and software.

Any tool that can simplify this process will help us better achieve our compliance goals.

Many manufacturers in the industry regulated by the U.S. Food and Drug Administration (FDA) use our Olympus CIX100 technical cleanliness inspection system . The CIX100 system has the advantages of intuitive interface, efficient data collection and rapid reporting, which helps users quickly and easily evaluate the cleanliness of manufactured components to determine whether they meet company and international standards.

Use the CIX100 cleanliness detection system to simplify the compliance process for Part 11 of 21 CFR

The 21 CFR Part 11 package of the Olympus CIX100 cleanliness inspection system demonstrates how the CIX100 system meets each of the requirements in Article 11 of 21 Code of Federal Regulations, and provides documentation on system settings and system operations. If the procedures in the package are implemented correctly, the testing of the CIX100 system will comply with the requirements of Article 11 of the 21 Code of Federal Regulations.

The contents of the package are as follows:

A document detailing how the CIX100 system with Adobe Sign (Adobe Sign) meets the specific requirements in Article 11 of “21 Code of Federal Regulations”

CIX100 verification protocol for installation qualification/operation qualification (IQ/OQ)

The CIX100 system complies with the standard operating procedures (SOP) required by Article 11 of “21 Code of Federal Regulations”

Work instructions for CIX100 system related to the setup and operation of the requirements of Article 11 of “Chapter 21 of the Code of Federal Regulations”

A guide map to ensure that the test meets the requirements of Part 11 of the 21 CFR

The detailed information provided by the package clearly conveys to users the knowledge needed to meet the requirements of Article 11 of the 21 CFR. This includes the solutions we provide, as well as any remaining user responsibilities. Below we briefly outline our solutions and user responsibilities.

Olympus’s solution to Article 11 of “21 Code of Federal Regulations”:

Validate the system through the installation qualification/operation qualification (IQ/OQ) method to obtain accurate and reliable results

Provide training on CIX100 for microscope users

Through detailed standard operating procedures (SOP) to ensure accurate operation

Through Windows PC login and user rights management, only authorized individuals are allowed to access the system

Use the Adobe Sign function to provide electronic signatures and track the PDF report of sample testing

The user’s responsibilities are as follows:

• Provide training on Adobe Sign’s electronic signature and electronic data tracking
• Establish policies for the use of CIX100 software with Adobe Sign, as well as the follow-up of access and revision of previous sample test reports
• Maintain procedures related to loss management and document retention

This package of the CIX100 system not only helps to simplify the cleanliness testing process, but also helps to meet the important standards of the U.S. Food and Drug Administration (FDA) regarding electronic records and signatures.