ACADEMY: E-SIGNING
Industry Regulations and Standards
Industry Regulations and Standards for E-Signing
Biometric Signature Data Interchange Standard
SOFTPRO E-Signing solutions are supporting the ISO/IEC 19794-7 storage format. This standard was co-defined by SOFTPRO's scientists who play an active role now for years in the ISO and participate in their meetings as well as workingin the national body of ISO DIN. Working with SOFPRO allows our partners and customers to tap on first hand expertise about Biometric Standardization.
The International Standardization Organization (ISO) is defining standard for Biometrics. The ISO/IEC standard (19794-7:2007), Information Technology – Biometric Data Interchange Formats – Part 7: Signature/Sign time series data specifies two data interchange formats for signature/sign behavioral data captured in the form of time series using devices such as digitizing tablets or advanced pen systems. One data interchange format is for general use and the other is a compact format for use and the other is a compact format for use with smart cards or tokens. ISO/IEC 19794-7 Standard
Encryption Standards
The signatures are saved as X.509 / PKCS#7-Objects within the document.Information about Encryption Standards Wikipedia EN about ... X.509Wikipedia EN about ... Public-Key Cryptography Standards (PKCS)
Document Management Standard
The document itself (signatures and all) is saved in a PDF format that complies with Standard ISO 32000-1:2008 / Adobe PDF 1.5.
If the integrity of a document would have to be checked at a later stage, an integrity validation may be executed with almost every PDF reader - including Adobe Reader to track if the document was subject of manipulation attacks after it was signed. ISO 32000-1 Standard
United States: FDA E-RECORD Regulation Framework for Electronic Signatures. (21, CFR Part11)
The US Food & Drug Association (FDA) dominates world wide as authority, issuing approvals and surveying quality assurance processes. The FDA E-RECORD Regulation Framework for Electronic Signatures contains a pragmatic definition of requirements with high acceptance in industry and administration: Requirements for electronic documents should not be superior to those on paper based documents. Records must clearly indicate:
Doctors and pharmacies in the United States are compelled to implement workflow automation processes that allow for the signing of HIPAA regulated forms (informed consent for the transfer of medical information) without paper. SignDoc can ease hospitals and pharmacies from the "paper burden".
United States: Government Paperwork Elimination Act (GPEA) of 1998
In its revised version of October 21, 2003 GEPA requires agencies to provide for the use and acceptance of electronic signatures where such signatures are applicable.
The US Food & Drug Association (FDA) dominates world wide as authority, issuing approvals and surveying quality assurance processes. The FDA E-RECORD Regulation Framework for Electronic Signatures contains a pragmatic definition of requirements with high acceptance in industry and administration: Requirements for electronic documents should not be superior to those on paper based documents. Records must clearly indicate:
- printed name of the signer
- The date and time of signature execution
- The intended meaning (review, approval, etc.) associated with the signature
Doctors and pharmacies in the United States are compelled to implement workflow automation processes that allow for the signing of HIPAA regulated forms (informed consent for the transfer of medical information) without paper. SignDoc can ease hospitals and pharmacies from the "paper burden".
United States: Government Paperwork Elimination Act (GPEA) of 1998
In its revised version of October 21, 2003 GEPA requires agencies to provide for the use and acceptance of electronic signatures where such signatures are applicable.