Automation
Elixir — Pharma Document Automation
Automated pharma document generation using dynamic PDF templates, streamlining regulatory workflows that previously relied on manual drafting.
01
Overview
Pharma regulatory submissions require large numbers of structured documents generated from underlying data. Producing them by hand doesn't scale and invites transcription errors in a domain where errors carry regulatory weight.
02
Challenge
Regulatory documents have strict formatting and content requirements that can't drift between submissions, but the underlying data changes every time — the system has to keep every generated document structurally consistent while the content varies.
03
Architecture
Dynamic PDF templates are parameterized by regulatory data and rendered programmatically, separating the fixed document structure (required by regulation) from the variable content (specific to each submission).
- Regulatory Data Input
- Template Engine
- Dynamic PDF Generation
- Validation
- Output Document
04
Implementation
- Built a dynamic PDF template system parameterized by structured regulatory data.
- Automated generation of documents from input data, replacing manual drafting.
- Validation applied against generated output to catch structural issues before documents leave the pipeline.
05
Technologies
06
Engineering Decisions
Why dynamic templates instead of editing static documents per submission?
Regulatory formatting requirements are fixed, but the data behind each submission isn't. A template parameterized by data means one maintained format produces every output correctly, instead of hand-editing documents and risking drift.
Why validate generated output rather than trust the template?
A template can be logically correct and still produce a malformed document if the input data is incomplete or shaped unexpectedly. Validation catches that before a document reaches a regulatory workflow.
07
Reliability
- Structural validation runs on every generated document before it's treated as final output.
- Fixed template structure means formatting can't silently drift between submissions.
08
Outcome
Automated, template-driven document generation that replaced manual PDF drafting for pharma regulatory workflows.