FDA announce re-examination of 21 CFR Part 11
After much discussions with the industry the FDA announce that they are to re-examine the 21 CFR Part 11 regulations on Electronic Records and Electronic Signatures. Concerns were raised that the existing regulations would unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA 's stated intent in issuing the rule significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted discourage innovation and technological advances without providing a significant public health benefit A new guidance document is published and the FDA is to exercise enforcement discretion when auditing companies.