5 Common Myths About eTMF Debunked: Myth #2
Myth #2: eTMFs do not comply with existing regulations
Not true! eTMFs are now widely accepted among regulators, including the FDA and the European Medicines Agency, provided they meet certain criteria. For instance, <LINK www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice/qa-good-clinical-practice-gcp - external-link-new-window "Opens internal link in current window">Competent Authorities in the European Union</link> require that eTMFs fulfil the Directive 2005/28/EC for TMFs, and the relating guidance in Volume 10 of the rules governing medicinal products in the EU, in addition to ICH-GCP. While no two eClinical solutions are equal, you can trust that eTMFs are built around regulations and keep pace with evolving standards in the industry, whether regarding compliance, data protection, or IT security.
The eTMF from BSI Life Sciences is fully compliant with the following:
- GAMP 5®
- 21 CFR Part 11
- FDA General Principles of Software Validation
- EU GMP Annex 11
- ICH GCP E6 Addendum 2
- GDPR
Myth debunked:
State-of-the-art eTMF solutions ensure full compliance with national and international regulatory affairs legislation.
Next week we will debunk Myth #3: Migration from a paper TMF or other digital solutions will take time away from the actual research work. Stay tuned!
