eDacq is a 21 CFR part 11 compliant software package. 21 CFR Part 11 is a guidance document issued by the Food and Drug Administration, relating to the use of electronic records and signatures. As well as being password protected for log on, an administrator can configure eDacq so that the individual user must electronically sign data files, configuration files and ECG templates using their individual passwords. This step ensures traceability and is an important component of GLP compliance. Our software has been independently audited by ADN Europe to ensure that it is 21 CFR Part 11 compliant.
However, even if a software package is 21 CFR Part 11 compliant, you and your lab may still require some training to ensure that your electronic submissions fully meet the FDA standards. EMMS provide this training during installation and will support you in utilising the software to its full potential.
Please click on the link below to learn more about 21 CFR Part 11.
21 CFR Part 11