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For many years, our organization has been operating successfully, boasting modern laboratories that meet international standards. These laboratories are equipped with the latest technology devices and equipment, and we have built a strong team of experienced and trained personnel to operate them.
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Pharmaceutical Compliance-
Pharmaceutical Data Integrity and Security-
Compliance with FDA 21 CFR Part 11 for Data SecurityCompliance with FDA 21 CFR Part 11 for Data Security: A Comprehensive Guide
The Food and Drug Administrations (FDA) 21 Code of Federal Regulations, Part 11 (21 CFR Part 11), outlines the guidelines for ensuring the security, integrity, and authenticity of electronic records and signatures in the pharmaceutical and medical device industries. The regulation aims to provide a framework for companies to implement robust data security measures, safeguard against cyber threats, and maintain confidence in the accuracy and reliability of their digital data.
Why Compliance with 21 CFR Part 11 is Crucial
Compliance with 21 CFR Part 11 is essential for several reasons:
User authentication and authorization
Role-based access control
Audit trails for tracking user activity
Creation, modification, and deletion of records
User activity and login history
System configuration changes
Detailed Explanation of Key Requirements
Below are two detailed paragraphs in bullet point format with explanations or information:
Electronic Signatures: Ensuring Authenticity and Integrity
Electronic signatures must be unique and unambiguous
They must be linked to the person using them
The person using the electronic signature must have agreed to use it for the specific transaction or record
The electronic signature must be secure, tamper-evident, and non-repudiable
Electronic records must be stored in a secure, tamper-evident manner
They must be accessible for review and audit purposes
The company must have a data retention policy that outlines how long electronic records will be stored and archived
Data must be retained for at least 7 years after the expiration date of the product or device
The regulation aims to provide a framework for companies to implement robust data security measures, safeguard against cyber threats, and maintain confidence in the accuracy and reliability of their digital data.
2. Who must comply with 21 CFR Part 11?
Companies operating in the pharmaceutical and medical device industries are required to comply with 21 CFR Part 11.
3. What is an electronic signature under 21 CFR Part 11?
An electronic signature is a unique identifier that an authorized person uses to authenticate their identity.
4. How often should audit trails be reviewed and updated?
Audit trails must be reviewed and updated regularly, at least daily, to ensure complete and accurate tracking of user activity.
5. What are the consequences of non-compliance with 21 CFR Part 11?
Failure to comply with 21 CFR Part 11 can result in severe consequences, including fines, reputational damage, and even product recalls.
By understanding the requirements and implementing robust data security measures, companies can ensure compliance with FDA 21 CFR Part 11 and maintain confidence in their digital data.
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