ECTD Validation

Before the scientific merit of a regulated healthcare product can be measured, the submission itself is subject to scrutiny. During validation, a submission is scanned for errors such as corrupt hyperlinks, non-allowable file types and incorrect naming conventions. The presence of errors can delay or prevent the processing of a submission. Awareness of the most common error occurrences and best practices instills a sense of confidence in the team responsible for the submission.

As trusted advocates and innovators in the eCTD industry, we have a few best practices for the validation portion of your submission process.

1. Understand Regional Validation Criteria

Regional health authorities in Asia, Europe, North America, Australia and the Middle East each have their own unique validation criteria. These authorities routinely publish updated versions of validation criteria online. While it is important to understand how validation criteria differs from region to region, using an intuitive software application that accounts for these updates is instrumental to guarantee compliance with whichever criteria are set forth.

2. Understanding the Efficacy of Your Validation Tool

eCTD is the preferred submission method for healthcare products. Filing in eCTD format is now mandatory in certain European locations, and the US FDA’s mandate was announced last year. As more regions shift from paper submissions to eCTD, validation standards are becoming more rigorous. The FDA currently validates for more than 200 error conditions of varying severity. It is worth noting that regional health authorities classify error conditions differently. For example, EMA rates errors as pass/fail while the FDA uses a high/medium/low rating system.

In the past, FDA reviewers were able to exercise discretion if errors were detected. A recent system upgrade gave the Agency the ability to automate the review process. Without the possibility of human intervention, a trustworthy validation tool is the difference between acceptance and rejection. GlobalSubmit VALIDATE™ is the only application on the market that offers Live Validation, which gives users the ability to detect and correct errors in real time without having to run unnecessary publishing cycles.

3. Never Manually Edit XML

Publishing tools have difficulty remaining in sync with your submission when users decide to manually edit eCTD XML code. There are mature platforms available on the market that verify the structural integrity of your XML automatically. This way, manual editing doesn’t have to come into play.

4. Correct All Errors Prior to Submission

Many organizations decide not to correct all errors, assuming some errors are not of a critical nature. Underestimating the seriousness of low and medium errors may not lead to rejection, but could make a submission unreviewable; this classification requires an organization to submit additional information citing delay. A good way to summarize and categorize your errors is to run a validation tool prior to your submission. The FDA strongly recommends eCTD validation before sending a submission. VALIDATE provides not only error checking, but also robust reporting that allows you to summarize and systematically correct all errors.