Articles Tagged with ''Part 11''

Part 11 Requirements Still Important, Industry Experts Warn

The FDA has not lost interest in electronic data integrity, audit trails or computer system validation, even though it has stated it will exercise enforcement discretion regarding 21 CFR Part 11, experts stressed at FDAnews' recent FDA Information Management Summit in Bethesda, Md.

Read More

Guidant's Response to Form 483 Emphasizes Part 11 Controls

Although Guidant disagreed with the FDA’s recent observation of apparent software validation and electronic records control violations, the company said it would examine and strengthen the relevant in-house requirements and implementation guidelines to ensure compliance with 21 CFR Part 11.

Read More

FDA May Delay Overhaul of Part 11, Agency Official Says

The FDA is unlikely to complete its long-awaited revision of 21 CFR Part 11 — which regulates the use of electronic records and signatures — by the end of the year as industry observers had expected, an agency official said this month.

Read More

System Upgrades Likely Needed to Submit eCTD to FDA

Drugmakers planning to submit electronic common technical documents (eCTDs) to the FDA will likely have to upgrade their systems, despite claims from the agency that system enhancements won’t be needed, says an industry consultant.

Read More

Warning Letter Reveals FDA's Part 11 Enforcement Stance

A recent warning letter citing 21 CFR Part 11 validation and control requirements sends a clear signal that the FDA intends to enforce the electronic records and signatures rule even as the agency moves toward revising it, industry experts say.

Read More

FDA Approves Service Provider's Electronic Safety Reports

Sentrx has completed an FDA electronic submissions pilot and has begun sending individual case safety reports (ICSRs) from a leading pharmaceutical company to the agency through the Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway, the technology company announced April 4.

Read More