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21 CFR Part 11 Compliant

Digitize Your Pharmaceutical Data

Harness your data, replace spreadsheets and emails, automate data extraction from paper, and collaborate with your internal and external partners. 21 CFR Part 11 compliant.

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Three reasons

Why pharma teams use GXP Share

Live
Real-time submissions

See data the day it is collected

Batch data appears in your dashboard the moment a CMO submits it. You can spot deviations and follow up before the next email cycle.

21 CFR
Part 11-ready controls

Built for regulated workflows

Validated entry, electronic signatures, and a tamper-evident audit trail are part of every submission. The technical controls needed for 21 CFR Part 11 are built in.

AI
OCR-driven insights

Turn paper into insight

Upload a scan and GXP Share extracts the field values into a validated template, ready for review. Even legacy paper batches become structured data your analytics and AI tools can use.

How it works

From a template to an inspection-ready record

Four steps that your team and your CMO and CLO partners run together for every batch.

01

Configure templates

Create templates for automated data extraction, manual entry, or file sharing. Validation rules and a predefined structure ensure you stay in control of your data. No code required.

02

Invite your collaborators

Invite internal teams or external partners. Scoped access ensures partners only see the templates assigned to them.

03

Enter and verify

Users complete the templates in their browser. Controlled workflows, optional verification, and conflict resolution keep you compliant.

04

Use your data

Export verified records in multiple formats, run in-built analytics, or connect to your data directly via API.

See the full workflow →
Live
Submissions appear in real time, not via email
Hours
From kickoff to first submission, not months
Logged
Every submission, correction, and export
21 CFR
Part 11 compliant

Common questions

Frequently asked questions

How long does setup take? +
Setup is measured in hours, not months. Upload a CSV of your existing form, configure the field types, and invite your CMO or CLO by email. They can start submitting immediately. There is no backend to integrate or custom code to write.
What is double-blind verification? +
Two operators enter the same batch data independently, without seeing each other's values. The system flags any disagreements and a third reviewer decides which value is right. It's the digital version of the double-entry process you already use on paper.
Does GXP Share support external CMO and CLO partners? +
Yes. External partners receive an email invitation and only see the templates you have assigned them. You set their role (submitter, reviewer, or read-only) and can revoke access at any time.
What export formats are available? +
PDF (with a tamper-detection hash), CSV, and JSON. Bulk exports are delivered as a ZIP. The audit trail is included with every export, so each file is sufficient on its own when an inspector requests it.
How is data integrity enforced? +
Every action is logged with the user, timestamp, and reason. Original records are never deleted or overwritten. Corrections create a new version so the full history remains visible.
What does pricing look like? +
Pricing depends on the number of engagements and partner organizations involved. We will walk you through it on the demo call.

Replace your paper batch records

Pharma teams are running batch data collection on GXP Share instead of spreadsheets. Setup is measured in hours, not months.

Book a Demo Today See How It Works