How the eCTD Accelerator – Viewer Streamlines Regulatory Submissions

eCTD Accelerator – Viewer: Key Features and User GuideThe eCTD Accelerator – Viewer is a specialized software tool designed to simplify, speed up, and standardize the review of electronic Common Technical Document (eCTD) packages. It helps regulatory affairs teams, reviewers, and submission preparers visualize the hierarchical structure, navigate document sets, validate content, and annotate files efficiently. This guide explains the Viewer’s core features, how to use them in real working scenarios, and best practices to integrate the Viewer into your regulatory workflow.

Why a dedicated eCTD viewer matters

Regulatory submissions in eCTD format contain complex hierarchies (modules and sequences), diverse file types (PDFs, XMLs, images), and metadata that must conform to strict agency standards. A purpose-built viewer:

Presents the submission tree clearly so users can find documents quickly.
Exposes metadata and XML backbone elements that generic PDF viewers hide.
Supports validation highlighting to spot structural or metadata errors fast.
Facilitates collaboration via notes, bookmarks, and change tracking.

Result: faster reviews, fewer mistakes, and smoother handoffs between teams.

Key Features

The Viewer displays the submission as a hierarchical tree matching the eCTD backbone (modules, sequences, folders, leaf nodes). Key capabilities:

Collapsible/expandable branches to focus on relevant modules.
Quick-search within the tree for filenames, document titles, or IDs.
Breadcrumbs and path copy for direct referencing.

Practical benefit: locate a single document in a multi-thousand-file submission in seconds.

2) Side-by-side document rendering

Open multiple documents concurrently in tiled or tabbed views. This is useful for:

Comparing cross-referenced documents (e.g., clinical study report vs. summary).
Viewing the XML backbone alongside a PDF to inspect metadata mapping.

Supports synchronized scrolling and text search across opened documents.

3) XML backbone and metadata inspector

The Viewer exposes the eCTD XML backbone and associated metadata (e.g., document type, submissionType, operation). Features include:

Color-coded XML nodes for quick identification (e.g., new vs. replaced documents).
Inline display of metadata fields and values.
Validation flags when required metadata are missing or inconsistent.

This turns the Viewer into both a visualizer and a preliminary QA tool.

4) Validation and error highlighting

The Viewer integrates validation checks for common eCTD issues:

Missing required files for a given folder/leaf.
Incorrect MIME types or file extensions.
Discrepancies between XML metadata and file attributes.
Structural errors in the sequence or module organization.

Errors and warnings are grouped with links to the relevant node so users can jump directly to the problem.

5) Annotations, bookmarks, and review workflows

To support collaborative review:

Add annotations (comments, highlights) anchored to specific pages or text ranges.
Create bookmarks to mark important documents or review checkpoints.
Assign review tasks or statuses (e.g., “Needs Edit”, “Reviewed”) and filter by status.

Annotations can be exported as reports to feed back to authoring teams.

6) Redaction and privacy tools

The Viewer often includes redaction utilities to hide sensitive information prior to sharing, with audit logs showing who redacted what and when. Typical features:

Select-and-redact text or graphical areas.
Apply redaction stamps or reason codes.
Export redacted versions while preserving originals.

This is critical for sharing documents with external partners or public-facing submissions.

7) Full-text search and indexing

A fast, full-text search across all documents and metadata allows:

Searching within PDFs and OCR’d images.
Filtering search results by module, document type, or status.
Saving common searches for recurring review needs.

Search results link directly to the exact page and highlight hits.

8) Exporting, printing, and packaging

The Viewer supports exporting subsets or full sequences for offline review, printing binders, or repackaging into submission-ready ZIPs. Export options often include:

Export selected files with or without annotations.
Create reviewer packs (e.g., Module 2 and key Module 5 docs).
Generate audit-ready reports that list file properties and validation results.

How to use the Viewer — step-by-step guide

Initial load and indexing

Import an eCTD sequence or entire dossier (commonly via drag-and-drop or file import).
Allow the Viewer to parse the XML backbone and index files — this usually takes seconds to minutes depending on size.
Review the validation summary shown after indexing; address any critical errors before beginning detailed review.

Navigating to a document

Expand the submission tree by module and sequence.
Use the quick-search box to jump to a document by title, filename, or document ID.
Click the node to open the document in a viewer pane; use breadcrumbs to copy the path.

Inspecting XML and metadata

Select a document node and open the metadata inspector panel.
Review documentType, MIME type, operation (new/replace/delete), and any human-readable title or author fields.
If metadata is missing or inconsistent, flag it in the validation panel and add an annotation.

Annotating and assigning tasks

Open the document page and highlight or add a comment anchored to the text or region.
Tag the annotation with a category (e.g., technical, regulatory) and assign to a reviewer or author.
Track responses and change status as the item is resolved.

Redaction and export

Create a redacted copy by selecting sensitive areas and applying redaction.
Review the redaction audit log to confirm actions.
Export the selected documents or the entire sequence as a reviewer pack or submission package.

Best practices and tips

Validate early and often: run the Viewer’s validation immediately after import to catch structural issues before deep review.
Use bookmarks for common review paths: define a set of reviewer packs (e.g., Module 2 overview, Module 5 clinical core) to speed recurring tasks.
Keep annotations actionable: include clear next steps and assignees in comments.
Use metadata as the single source of truth: check XML backbone values rather than relying only on folder names.
Maintain original files: the Viewer should let you export redacted or annotated versions while preserving the pristine originals for regulatory submission.

Example workflows

Routine QA of a new sequence

Import new sequence → run validation → fix critical structure/metadata errors → perform targeted review of Module 2 summaries and Module 5 key reports → annotate and assign edits → export corrected sequence for re-submission.

Cross-team review before submission

Build a reviewer pack (e.g., CMC + clinical overview) → distribute redacted pack to external consultants → collect annotations and action items → reconcile changes in the authoring system.

Limitations and considerations

Viewer capabilities vary by vendor — features described above may be optional or implemented differently.
For very large dossiers, performance depends on indexing strategy and local hardware/hosting environment. Consider server-based deployments for enterprise scale.
The Viewer aids review and QA but is not a replacement for final validation against agency submission standards using dedicated validation engines prior to filing.

Conclusion

The eCTD Accelerator – Viewer centralizes visualization, metadata inspection, validation, and collaboration for eCTD submissions. By exposing the submission structure, surfacing XML backbone details, and enabling annotation and redaction workflows, it reduces review time, improves accuracy, and helps regulatory teams deliver cleaner submissions. Integrate the Viewer into your process early, follow metadata-driven best practices, and use its export tools to streamline collaboration and final packaging.