CFR 21 Part 11

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2 07, 2018

Nontransferable Obligations: Why Sponsors Fail Inspections

2019-08-02T15:55:31-04:00

Part 1: Lack of Oversight Discussion of FDA inspections, whether for cause or part of a routine GCP inspection, usually centers on the inspection of trial sites and the CROs who are tasked with managing them. The reason for the disproportionate focus on the inspection of trial sites and CROs stems from two material [...]

Nontransferable Obligations: Why Sponsors Fail Inspections2019-08-02T15:55:31-04:00
13 06, 2018

How to Avoid the Top 5 Clinical Trial FDA Inspection Failures

2020-03-11T16:19:49-04:00

Your heart begins beating faster and sweat begins forming on your forehead - the FDA is calling. Many things can trigger an FDA inspection - most falling into routine study-related visits, while some are "for cause," stemming from complaints or sponsor concerns. Sites that have a new drug application will most likely experience an FDA inspection. [...]

How to Avoid the Top 5 Clinical Trial FDA Inspection Failures2020-03-11T16:19:49-04:00
19 03, 2018

How to Use Electronic Signatures (eSignatures) in Clinical Trials

2020-03-18T10:26:10-04:00

Electronic signatures, eSignatures, are continuing to gain momentum replacing wet signatures in Clinical Trials. Wet signatures are signatures made by hand on a document, typically with a pen and paper, which are often later electronically scanned into a storage system or maintained on paper and stored in a binder room. Electronic Signatures, often called [...]

How to Use Electronic Signatures (eSignatures) in Clinical Trials2020-03-18T10:26:10-04:00
7 02, 2018

Innovations | The time is now for eRegulatory and eSource

2019-08-02T16:05:10-04:00

Innovation matters in Clinical Research… The adoption of new technology, in any industry, follows a familiar cycle outlined by Geoffrey Moore in his book Crossing the Chasm, Innovators: Innovators are the first individuals to adopt an innovation. These individuals/teams are willing to take a risk to help advance a solution. Early Adopters: These are the [...]

Innovations | The time is now for eRegulatory and eSource2019-08-02T16:05:10-04:00
19 12, 2016

What if I get audited?

2019-08-02T16:09:42-04:00

A common question many teams ask as they face the transition to digital study documents is, “What if I get audited?” Inspections evoke fear because negative audit findings significantly impact everyone. Areas of high risk include missing documents, accurate delegation of authority logs, reporting delays, and inadequate monitoring or PI oversight. Given these risks, some [...]

What if I get audited?2019-08-02T16:09:42-04:00