What Does 21 CFR Part 11 mean?
21 CFR PART 11 is a regulation issued in 1997 by the US government agency FDA (“Food and Drug Administration”) that describes the requirements and standards for the handling of electronic data.
This regulation describes how online electronic record and electronic signature must be implemented when data is processed electronically or transmitted to the FDA in electronic form
Because FDA inspectors are increasingly implementing these rules, it is becoming necessary for laboratory data processing to confirm to these standards.
Federal Drug Administration (FDA)-USA, Regulation on electronic signature & digital records.
21 CFR PART 11 stipulates measures to be in corporate in the design of hardware & software to protect data from tempering.
SMART LOG 2000 is a readout and programming software for AMBETRONICS data loggers, indicators and controllers. During readout of a instruments, special files (electronic records) are generated that can be analyzed, signed, administered and filed with SMART LOG 2000.
SMART LOG 2000 was developed with strict observance to the ISO 9001 certified AMBETRONICS Product Development Guidelines and was thoroughly documented and tested to conform with the standards of 21 CFR PART 11 SMART LOG 2000 helps you to observe and implement the FDA guidelines through a series of measures:
˜ Automatic generation of audit trails.
˜ Advanced user administration.
˜ Electronic signatures for files containing measurement data.
˜ Safeguard against manipulation.
˜ Electronic Standard Operating Procedures (SOPs).
SMART LOG 2000 must be operated with a suitable operating system (Windows Xp or Windows 2000 or higher version) in order to meet the requirements of the FDA standards.
|
Download Catalog