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SECTION 1

Before you evaluate anyone,
understand two things.

Your workflows and your documents. Every vendor you'll talk to will affect one or both.

Workflows

Everything around the document. Uncodified, distributed, evolved over years.

+

Documents

The thing itself. Predictable, universal, the same five stages every time.

We'll start with the hard part.
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02 / 07
WORKFLOWS

Every document type has
its own world around it.

IQ PROTOCOL
DRAFT
W
IQ Protocol
Autoclave #3
PRE-APPROVE
✓
Pre-Approve
EXECUTE
✏
Execute
POST-APPROVE
✓✓
Post-Approve
ARCHIVE
▤
Archive
👥 Drafters & Reviewers
🔑 Delegation of Authority
📋 Governing SOPs
🎓 Training Matrix
#️⃣ Document Control
🔄 Change Control
⏱ SLAs & Deadlines
⚠️ Escalation Procedures
🧠 Institutional Knowledge
🔧 Calibration Schedule
⚙️ Equipment Register
🧪 Sampling Plan
📦 Bill of Materials
📅 Production Schedule
🚨 Deviation Handling
🧑‍🔬 Qualified Operators
🏠 Room / Area Status
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03 / 07
THE UNIVERSAL TRUTH

These are the only things
that didn't change.

192 GxP document types. Completely different workflows.
The same five stages - every time.

DRAFT
W
Author in
Word
PRE-APPROVE
✓
Review &
Approve
EXECUTE
✏
Fill in &
Complete
POST-APPROVE
✓✓
QA Review
& Release
ARCHIVE
▤
Store &
Retain
192 document types. Thousands of site-specific rules.
One lifecycle underneath all of them.
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DOCUMENTS

Every GxP document follows
the same five stages.

The path is universal. The same for SOPs, batch records, protocols, and CAPAs.

01
Draft
Author the document in Word. Define procedures, acceptance criteria, and responsibilities.
02
Pre-Approve
Route for review and collect signatures. Confirm the document is ready for execution.
03
Execute
Perform the work. Fill in results, record observations, and capture data in real time.
04
Post-Approve
Route the completed record for final review. Verify data integrity and completeness.
05
Archive
Store the approved record in a controlled repository for the required retention period.
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Select a stage
01
Draft
02
Pre-Approve
03
Execute
04
Post-Approve
05
Archive
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THE THREE PATHS

How do you stop
the Paper Detour?

Workflows are intangible - they already work. Documents are the only physical thing left. The question is how you solve that one stage.

END-TO-END PLATFORM
E-COMPLETION (POINT SOLUTION)
UNCHANGED
PATH A
Replace the whole thing.
An end-to-end platform where the document becomes structured data and the workflow becomes visible, automated routing. More powerful - but nothing looks the same.
DraftPre-AppExecutePost-AppArchive
WHAT CHANGES
Everything - new SOPs, retraining, revalidation, new mental models
WHAT STAYS
Your regulatory obligations
NEW
PATH B
Combine.
Your QMS already handles steps 1, 2, 4, and 5. Where it currently says "print this" - plug in an e-completion tool instead. The QMS stays the backbone.
DraftPre-AppExecutePost-AppArchive
WHAT CHANGES
Step 3 - your QMS gets a digital partner
WHAT STAYS
QMS as system of record, SOPs, training, workflows
NEW
PATH C
Digitise the document.
A point solution that handles digital execution. Everything else stays exactly as it is. Your QMS, your SOPs, your Word templates - untouched. You just stop printing.
DraftPre-AppExecutePost-AppArchive
WHAT CHANGES
Step 3 - execution goes digital
WHAT STAYS
QMS, SOPs, training, Word templates, workflows - everything
None of these is wrong. But they are fundamentally different things to buy.
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Most buyers don't discover
the difference until they're
already implementing.

Understanding your workflows and your documents - before you talk to any vendor - is the single most valuable thing you can do.

Continue to Section 2 →