Title 21 cfr part 11
21 CFR Part 11 ,Compliance with Part 11 of Title 21 of the Code of Federal Regulations in the context of technical cleanliness inspection: a quick guide
Technical cleanliness control
Part 11 of Title 21 of the US Code of Federal Regulations (CFR) defines electronic data integrity criteria that must be met by the Food and Drug Administration (FDA). Entities operating in industries subject to FDA oversight, such as medical device manufacturers and pharmaceutical companies, must meet 21 CFR Part 11 requirements for electronic record keeping integrity and the use of electronic signatures.
However, meeting these requirements can be difficult and time-consuming. In this blog article, we’ll look at the common challenges faced in meeting the requirements of Part 11 of Title 21 of the Code of Federal Regulations and discuss how to meet them.
Challenges to Compliance with Title 21 Part 11 of the Code of Federal Regulations
To comply with title 21 cfr part 11, an entity will typically need to develop manuals that address each of the requirements listed in these regulations, establish validation protocols to confirm that hardware and software configuration, operation and performance are valid, develop Standard Operating Procedures (SOPs), and train personnel thoroughly. with hardware and software support.
No wonder any tools to facilitate this process are welcome.
Many manufacturers in industries regulated by the FDA use our OLYMPUS CIX100 system for technical cleanliness . As a solution with an intuitive interface, effective data acquisition mechanisms and functions for rapid reporting, the CIX100 system allows you to quickly and easily assess the purity of manufactured products in order to verify their compliance with company and international standards.
Technical cleanliness control system
OLYMPUS CIX100 cleanliness control system.
To help you meet regulatory requirements, we have developed a 21 CFR Title Part 11 Compliance Pack for the CIX100 Cleanliness Control System.
The OLYMPUS CIX100 Cleanliness Inspection System helps you meet 21 CFR Part 11 requirements
Our 21 CFR Part 11 Compliance Pack provides information on how the CIX100 can meet each requirement, as well as the necessary documentation for system setup and operation. When properly implemented, the CIX100 system will meet the 21 CFR Part 11 requirements.
Package includes:
Documents that describe how the CIX100 with Adobe Sign software meets the specific requirements of 21 CFR Part 11;
CIX100 system validation protocol for installation qualification / operation qualification (IQ / OQ);
Standard Operating Procedure (SOP) for the CIX100 according to 21 CFR Part 11;
CIX100 setup and operation work instructions in accordance with 21 CFR Part 11.
21 CFR Part 11 Compliance Plan
The detailed material included in the package clearly describes the activities and formalities required to comply with Part 11 of 21 CFR Title. In particular, they indicate the solutions provided by Olympus and the obligations incumbent on the user. Here is a brief overview of them:
Olympus solutions for 21 CFR Part 11 compliance:
System validation for installation qualification / operational qualification (IQ / OQ) – to ensure the accuracy and reliability of the results.
CIX100 system training for microscope users.
Ensuring the correctness of service by providing a detailed standard operating procedure (SOP).
Allowing access to the system only to authorized persons by logging into the Windows computer and managing user permissions.
Use of Adobe Sign software to handle electronic signatures and trace the origin of PDF sample inspection reports.
User Responsibilities:
Providing training in the use of Adobe Sign software for handling and tracing the origin of electronic data.
Development of rules for using CIX100 software with Adobe Sign software and logging access to previous reports on sample control and modification of these reports.
Maintaining procedures for dealing with information loss and document storage.
The CIX100 system with such a package can improve cleanliness inspections and facilitate compliance with important FDA requirements for electronic record keeping and the use of electronic signatures.
