Don’t Let eCTD Submission Sequences Jeopardize Your FDA Compliance
The Compliance Risks of Poor eCTD Document Management
As a sponsor, maintaining FDA submission records is not just a responsibility—it’s a regulatory requirement. However, many sponsors face challenges when their eCTD vendors store submission sequences in outdated or inaccessible systems.
This lack of access creates significant compliance risks, including:
- Inability to Retrieve Sequences: Delays during FDA audits due to inaccessible records.
- Outdated Platforms: Vendors relying on FTP sites or other antiquated systems that are difficult to navigate.
- Noncompliance Observations: FDA inspections frequently highlight poor document management as a critical finding.
Real-World Consequences of Inaccessible eCTD Sequences
How Poor Vendor Practices Lead to FDA Observations
One sponsor shared their experience during an FDA inspection when they couldn’t retrieve specific safety information from their IND. The inspector found the submission sequences were not properly archived, leading to a formal observation for lack of oversight.
In another case, a manufacturing facility discovered during an audit that their vendor’s contract didn’t specify where or how submission sequences were stored. This lack of accountability resulted in noncompliance findings.
How eCTD Submit Solves Submission Sequence Challenges
Ensuring Secure, Accessible, and Compliant Submissions
At eCTD Submit, we take a client-first approach to eCTD submission sequence management. Our solutions address the common challenges sponsors face:
- Platform-Agnostic Document Management: We don’t lock clients into a single system, ensuring you maintain full control over your documents.
- Immediate Access to Submission Sequences: We provide searchable archives of all submission sequences, including ESG receipts, for audit readiness.
- eCTD Navigatorˢᴹ Tool: This intuitive web-based interface mirrors the FDA’s eCTD module format, ensuring you view submissions as regulators will see them.
Benefits of Partnering with eCTD Submit
- Audit-Ready Submission Records: Ensure your eCTD sequences are always organized, accessible, and compliant.
- Full Submission Ownership: Retain complete control of your submissions, without reliance on outdated vendor platforms.
- Simplified Navigation: Our tools eliminate the stress of accessing and managing submission sequences.
- Expert Support: Gain one-on-one guidance to ensure every aspect of your submission meets FDA standards.
Why Control Over eCTD Submission Sequences Matters
Properly managed eCTD submission sequences are essential for avoiding compliance risks and ensuring successful FDA audits. Sponsors who partner with a proactive vendor like eCTD Submit can:
- Avoid FDA observations for poor document management.
- Ensure timely responses to inspection requests.
- Protect their regulatory submissions and compliance status.
Secure Your eCTD Submission Sequences Today
Don’t risk noncompliance or audit findings due to inaccessible submission sequences. With eCTD Submit, your submission data stays secure, accessible, and under your control.
Contact us today to learn how we can help you manage your eCTD submission sequences and stay audit-ready.
