A purpose-built eRegulatory and eSource solution can help significantly in surviving an FDA inspection – while also delivering a wealth of additional benefits for time-saving, capacity building, and accelerating trials.
The best plan to ensure Inspection Ready status is to make a strategic transition to digital today, before your next inspection. Why?
- Digital solutions reveal the unknown, making it easy to identify risks and proactively correct them.
- Since most sponsors are requesting digital documents, digital solutions keep your site out of a treacherous half-paper, half-digital state where disorganization can occur.
- Detailed 21 CFR Part 11 audit trails help you demonstrate to auditors and monitors the GCP steps you know your site is already taking.
- Ensures compliance leveraging a single source of truth across all your studies.
The benefits of this transition far outweigh the risks – which is why centers and sponsors around the world are making the change each day. It is also why the FDA is partnering with stakeholders to help drive digital transitions. Solutions like Florence eBinders give clinical trial site managers and their employees the tools they need to prepare for an FDA inspection such as:
Global Dashboards: never miss a document expiration date or due date
Remote Monitoring and Access Control: Always know who is accessing what and when (read more)
Automatic Audit Trails: Easily track when and who created, edited, and viewed a document or an entire binder
Secure Cloud-based Document Storage: All study documents stored in a secure centralized location available 24/7 from anywhere in the world – never lose another document
Direct EMR/EHR Integration: Capture source documentation directly from your EMR/EHR (read more)
Grant Access to FDA Auditors: Easily grant access to certain files to FDA auditors
Part-11 Compliant Signatures: Never worry about if the FDA will accept an eSignature on a document (read more)