• Ambetronics Engineers Private Limited

Compliance Software For Pharmaceutical Industries

Ambetronics Engineers 21 offers compliance software for CFR Part 11 is a regulation issued in 1997 by the US government agency FDA (Food and Drug Administration) that describes 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 data. Because FDA inspectors are strictly implementing these rules, it is becoming necessary for laboratory data processing to conform to these standards. The FDA regulation on electronic signature and digital records 21 CFR Part 11 manipulates measures to be incorporated in the design of hardware and software to protect data from tempering. Smart Log 2000 is readout and programming software for Ambetronics data loggers, indicators and controllers. During readout of instruments, special files (electronic records) are generated that can be analysed, signed, administrated and filed with Smart Log 2000. This 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 out to observe and implement the FDA guidelines through a series of measures, including: automatic generation of audit trails; advance user administration; electronic signature for file containing measured data; safeguard against manipulation; electronic standard operating procedures (SOPs), etc. It 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.