Industry standards
IBM® Records Manager contributes to meeting government and industry regulations that require formal records management. Regulations include:
US DoD 5015.2, June 2002 - Required for all US DoD agencies. Endorsed by and recommended for all US civilian agencies (but not yet mandated). Records Manager is also certified to US DoD 5015.2, June 2002 Chapter 4 (link resides outside of ibm.com), which ensures the correct management of the classification and declassification of highly sensitive electronic records.
SEC Rule 17a-4 (Securities and Exchange Commission).
FDA Rule 11 (21 CFR part 11) - The Food and Drug Administration (FDA) is issuing regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations affect human and veterinary pharmaceutical companies as well as biological products, medical device, and food interest groups, including 11 trade associations, 25 manufacturers, and 1 Federal agency.
OMB Circular 130 - The electronic recordkeeping policies in this Circular apply to the information activities of all agencies of the executive branch of the Federal government.
HIPAA - The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires healthcare organizations, insurers, and payors that have been using any electronic means of storing patient data and performing claims submission (including faxes, we are told) to comply with this new Final Rule for National Standards for Electronic Transactions.
