Accuracy and compliance are the key in the pharmaceutical profession and particularly when they present regulatory materials to health authorities. The simplest formatting mistake might mean rejection or subject to expensive delays. Submission eValidation guarantees that your electronic submissions are completed in all technical and structural compliance prior to sending regulators. It is an essential measure in compliance management and efficiency in submission.
What is Submission eValidation?
Submission eValidation is defined as the process used to ensure that an electronic regulatory submission commonly in eCTD (electronic Common Technical Document) format, is technically compliant based on the technical requirements established by regulatory bodies (FDA, EMA, MHRA, etc.).
It entails the process of running the submission package in the special tools of validation to validate the file structure, naming conventions, document formatting, metadata, and links. This procedure guarantees that the submission is technically appropriate, glitch-free, and can be accepted through the electronic gateway of the health authority.
Why Submission eValidation is Essential to Regulatory Compliance
Submission eValidation is not only a technical requirement but a safeguard against regulatory risk. Unless validated, submissions may be rejected prior to even reaching a reviewer, causing delays in deadlines and missing timelines on product approvals.
eValidation is necessary because:- Eliminates rejections related to formatting, metadata etc.
- Coordinates with region specific technical requirements (i.e., FDA vs. EMA)
- Mitigates rework and re-submission requirements
- Aids in consistency in several sequences, and submissions
- Supports faster review cycles by submitting technically sound files
- Enhances the general compliance position in inspections and audits
- By including eValidation as part of the submission process, organizations are able to sort out technical difficulties prior to affecting regulatory schedules.
Important Validation Checks All eCTD Submissions Should Meet
The efficient eValidation tools perform numerous checks to verify that the submission is compliant with the necessary technical standards.
Key areas include:- Accurate folder/file hierarchy using eCTD specifications
- Valid file naming conventions for documents and sequences
- Use of accepted file formats such as PDF, XML, and STF
- Properly formed and schema-compliant XML backbone files (e.g., index.xml)
- Functional hyperlinks and bookmarks within and across documents
- Detection of missing, corrupted, or inaccessible files
- Document lifecycle relationships verification (e.g. replace, append)
- Conformation to agency-specific validation rules and requirements
- These checks can facilitate a very comfortable submission procedure, and mitigate the risk of rejection or follow-up questions by regulatory agencies.
Reliable eValidation Tools Adopted by the Best Regulatory Teams
Regulatory staff uses designated eValidation software to carry out these checks effectively. The most reliable pharmaceutical tools are:- Lorenz Validator: An international-level tool that provides validation of eCTD, NeeS, etc.
- EXTEDO eValidator – Commonly used in Europe and supports various agency-specific validation requirements.
- GlobalSubmit Validate – Considered to be robust and ideal in FDA submissions.
- Veeva Vault Submissions Validator – Part of the Veeva Vault platform of end-to-end management of submissions.
- Agency-provided validators – Such as the FDA’s eCTD Validator or EMA’s automated validation tools.
These tools produce comprehensive validation reports and thus enable regulatory affairs teams to rectify issues ahead of final submission, enhancing the quality and first-time acceptance rates of the submission.
Submission eValidation is necessary in the modern dynamic pharmaceutical world in order to achieve smooth regulatory approval. MasuuGlobal is a reliable company you can trust with regard to delivering specific expertise in eValidation, to guarantee flawless, compliant and timely submissions. Our experienced staff uses the most up to date tools and industry best practices to enable your regulatory success at all levels. Collaborate with MasuuGlobal to receive efficient and accurate verification of submissions.