Regulatory Issues
The complexities of R&D, product trials, business transactions and ongoing communications with partners, consumers and government agencies have prompted exacting requirements for validating electronic information exchanges and transactions within and between organizations. New and existing laws and regulations put every organization’s approach to managing information under increased scrutiny. Many of these regulations require strict adherence to good time keeping practices.
The following is a list of regulatory issues that either have as part of their compliance a need for good time management or that would be well served with good time management.
FDA 21 CFR Part 11
21 CFR Part 11, the FDA guidelines for trustworthy electronic records, requires companies to employ procedures and controls designed to ensure the authenticity, integrity and when appropriate the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.
To satisfy this requirement persons must, among other things, employ procedures and controls that include the use of computer generated time stamps.
Find out how Symmetricom's NTP time servers and Domain Time II software can easily solve all of the time compliance requirements for 21 CFR Part 11. Click here.
OATS
NASD Rule 6953 requires member firms that record order, transaction, or related data required by the Bylaws or other rules of NASD to synchronize all business clocks, including both computer system clocks and mechanical time stamping devices, that are used to record the date and time of any market event. In addition, the Rule requires that member firms maintain the synchronization of such business clocks.
The SyncServer S100 is currently being used by a number of firms to comply with this OATS regulation. For more information on this rule click here.
E-SIGN
Electronic Signatures in Global and National Commerce Act ("E-SIGN") (Public Law 106-229) enacted on June 30, 2000. E-SIGN eliminates legal barriers to the use of electronic technology to form and sign contracts, collect and store documents, and send and receive notices and disclosures. To read the complete bill click here.
UETA
The UETA (Uniform Electronic Transactions Act) presents legal recognition of electronic records, electronic signatures, and electronic contracts.
- A record or signature may not be denied legal effect or enforceability solely because it is in electronic form.
- A contract may not be denied legal effect or enforceability solely because an electronic record was used in its formation.
- If a law requires a record to be in writing, an electronic record satisfies the law.
- If a law requires a signature, an electronic signature satisfies the law.
For the latest on the Uniform Electronic Transactions Act (UETA) click here.
Sarbanes-Oxley
Sarbanes-Oxley has legislated acceptable conduct regarding the retention of records; electronic and paper for public companies, executives and public. The law will form the Public Company Accounting Oversight Board, an entity that will be responsible for developing rules/regulations regarding public accounting and company accountability. The law mandates from the public accountants' perspective. For more information on Sarbanes-Oxley, click here.
Attention CIO’s and Their Staffs: Sarbanes-Oxley Compliance Deadline Moved to November 15th
17 CFR 240.17a-4
17 CFR 240.17a11 requires broker-dealers to give notice when certain specified events occur. Specifically, the rule requires a broker-dealer to give notice of a net capital deficiency on the same day that the net capital deficiency is discovered or a broker-dealer is informed by its designated examining authority or the Commission that it is, or has been, in violation of its minimum requirement under Rule 15c31.
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