Electronic Records; Electronic Signatures
In 1997 the FDA issued the http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf
In 1999 they issued this http://www.fda.gov/ora/compliance_ref/part11/FRs/updates/cpg-esig-enf.pdf
In early 2003 they issues a new draft guidance document http://www.fda.gov/cber/gdlns/prt11elect.pdf
Customer Expressions’ i-Sight Case Management software is designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Additional measures such as document encryption and use of appropriate digital signature standards are employed to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.
Customer Expressions’ i-Sight Case Management software allows you to remain compliant to 21 CFR Part 11 by providing the following features:
- Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
- The ability to generate accurate and complete copies of records in both human readable and electronic form.
- Protection of records to enable their accurate and ready retrieval throughout the records retention period.
- Limiting system access to authorized individuals.
- Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records.
- Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
- Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
- Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.
- Training of persons who maintain or use Customer Expressions’ i-Sight Case Management software.
- Use of appropriate controls over systems documentation including:
- Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
- Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.
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