CFR 21 Part 11 is a federal regulatory code that ensures the electronic storage, control, and archiving of documents and records. Established by the FDA in 1997, this regulation was designed to control the validation, registration, and electronic signature of documents. The purpose of the regulation is to ensure that documents stored in electronic systems are maintained with the same security as paper documents.
CFR 21 Part 11 requires that electronic documents be reliable and can be stored, retrieved, and reproduced accurately. The regulation applies to all organizations that collect or store information electronically or maintain an electronic database containing transaction data or other information that may be used as evidence in any legal proceeding.
“Records” refer to all tangible objects, including paper documents and magnetic tapes. Part 11 is a set of rules that outlines the methods for creating and storing electronic documents. It also contains information about the safeguard measures necessary to ensure the accuracy of these documents.
The electronic signature standard specified in this regulation describes which types of information can be electronically signed and how they must be used to comply with federal electronic signature regulations (e-signature).
The regulation was designed to ensure that documents stored in electronic systems are maintained with the same security as paper documents. The FDA has established a set of compliance guidelines for this standard that must be followed by all manufacturers and importers who use LIMS technology.
LIMS in the Pharma Industry
The Laboratory Information Management System (LIMS) is a computer system that automates the storage and management of laboratory data. A LIMS can be used to track results, manage samples and documents, and generate reports.
A LIMS enables companies to manage automatic data collection, records, and electronic signatures in compliance with the 21 CFR Part 11 guidelines. LIMS is a system that manages data collection, storage, and retrieval, helps manage data quality, and can be used to manage data analysis. Additionally, a LIMS helps store and manage documents and records.
To be compliant with 21 CFR Part 11 guidelines, companies must have a comprehensive understanding of how their laboratory information management system works and how it will be used by employees during daily operations. This means that it is important for employees to be trained and aware of the validation, registration, and electronic signature methods for documents.
Eusoft.Lab LIMS SaaS in Cloud
Eusoft.Lab LIMS has been designed to be compliant with CFR 21 Part 11 regulations, and as such, it has features that support the validation, registration, and electronic signature of documents. For example, LIMS allows defining access rules to data, limiting access only to those who have permission. Additionally, it allows tracking and recording changes made to data, as well as the electronic signatures of employees who made such changes.
Eusoft.Lab LIMS also allows secure and protected electronic document storage, ensuring access only to those who have the necessary authorizations. Furthermore, the system provides data backup and recovery functionality to ensure data is protected from any loss or damage.
Moreover, Eusoft.Lab LIMS provides reporting functionality, which allows managers to monitor the effectiveness of the system and generate reports to demonstrate compliance with CFR 21 Part 11 regulations. These reports can be used as evidence of compliance in case of regulatory inspections.
In conclusion, CFR 21 Part 11 is a federal regulatory code that ensures the electronic storage, control, and archiving of documents and records. LIMS has been designed to be compliant with CFR 21 Part 11 regulations and has features that support the validation, registration, and electronic signature of documents.