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# Electronic Record, Signature Guidance ‘Significant’: Attorneys
- URL: https://www.fdaweb.com/electronic-record-signature-guidance-significant-attorneys/
- Published: 2017-06-27T12:00:00.000Z
- Updated: 2026-09-14T22:31:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139042

Hogan Lovells attorneys say that the FDA 6/21 draft guidance on using electronic records and electronic signatures in clinical investigations is “a significant development because it signals that FDA nay be preparing to place greater scrutiny on electronic systems used in clinical trials to ensure that those systems meet Part 11 standards. More broadly, we think this is another clear indication that the agency is increasingly focused on the integrity of data submitted in support of new drug approvals.”

Writing in an online [post](http://ehoganlovells.com/rv/ff00318f39cd3bf5f981d9b78d41b1ec972de976?ref=fdaweb.com), the attorneys provide an overview of four of the main topics covered by the draft guidance: electronic systems owned or managed by sponsors, contract research organizations, and institutional review boards; outsourced electronic services; mobile technology, and electronic signatures.