Electronic John Hancocks: E-signatures, e-records replace paper
E-cards, e-mail, e-verify, e-z pass all have one thing in common – the e stands for electronic. Add two more to the lexicon, e-records and e-signatures, courtesy of FDA.
- Ensure system validation and the protection of records
- Ensure operational consistency across all departments
- Improve productivity and efficiency of existing staff
- Minimize and possibly eliminate the maintenance and retention of paper documentation
- Meet study timelines
- Perform faster study-related searches and establish trends
- Provide study-related submission information in formats acceptable to FDA
- Utilize appropriate controls to ensure that e-records/data and e-signatures are trustworthy, accurate, and complete.
- Use appropriate controls to ensure that clinical data are protected so that study related activities can be reconstructed.
- Use a risk-based approach for designing/utilizing computerized systems for clinical dataflexible regulations that support a risk based approach.