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The department of health and human services Food and Drug Administration 21 CFR Part 11 [Docket No. 92N–0251] released regulations and provided criteria for acceptance by FDA of Electronic Records; Electronic Signatures, and handwritten signatures either executed on paper or to electronic records.
21 CFR Part 11 was released March 20th, 1997 and provided criteria necessary for acceptance which include:
- Electronic records;
- Electronic signatures;
- Handwritten signatures executed to electronic records;
- Handwritten signatures executed on paper; and
As a manufacturer of medical imaging software, Merge OEM has integrated security features into its medical applications to help covered entities ensure that they are compliant with HIPAA requirements. Merge OEM has also build in backup for data redundancy into its systems providing high availability of data for continuity of operations.
Specific HIPAA Compliance for Merge OEM can be found in the following document:
For further information on these and other quality standards (including HIPAA, ISO 9001:2000, ISO 13485:2003, FDA QSR, Health Canada MDR, European MDD for CE marking) please contact us.
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