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21 CFR Part 11 Compliant

Digitize Your Pharmaceutical Data

Replace paper batch records and Excel email chains with validated digital templates. Real-time data from your CMOs and CLOs — FDA-compliant from day one.

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Why teams choose GXP Share

Why Pharmaceutical Companies Choose GXP Share

Faster
Real-time data review

Real-Time Visibility

See batch data the moment it's submitted — not days later when a spreadsheet arrives by email. Catch issues before they become deviations.

Validated
Field-level entry checks

Validated Entry

Field-level validation, required-field enforcement, and type checking eliminate the transcription mistakes that plague paper-to-Excel workflows.

21 CFR
Part 11 Compliant

Built for Compliance

Full audit trails, electronic signatures, and tamper-evident exports are built in — not bolted on. Your data is FDA-ready from the first submission.

The workflow

From Templates to Approved GMP Documents

A four-step workflow your whole organization can follow — from initial template setup to FDA-ready exports.

01

Configure Templates

Convert existing paper forms into validated digital templates in minutes — no coding required. Define field types, validation rules, and version control from a simple interface.

02

Collaborate Across Organizations

Invite your CMO and CLO partners to access templates via email. Manage role-based permissions and track submission status across every engagement in real time.

03

Enter and Verify Data

Collaborators fill out validated forms directly in the browser — no Excel, no paper. Double-blind entry and conflict resolution ensure every data point is independently verified.

04

Leverage Your Data

Export verified batch records as tamper-proof PDF, CSV, or JSON — complete with audit trails and electronic signatures. Ready for regulatory filings, analytics, and audits.

See the Full Workflow →
Faster
Reduction in data review vs paper + Excel
Day-one
Time to first submission, not month-long rollouts
End-to-end
Audit trail across submission, correction, export
21 CFR
Part 11 compliant out of the box

Common questions

Frequently Asked Questions

How long does setup take? +
Setup is hours of configuration, not a multi-month implementation project. Upload your existing form as a CSV template, configure field types, invite your CMO/CLO partners by email — and you're collecting live data. No backend integration or custom development required.
What is double-blind verification? +
Two operators enter the same batch data independently, without seeing each other's entries. The system flags any discrepancies, and a designated reviewer resolves conflicts. This mirrors validated paper workflows and satisfies FDA data integrity requirements.
Does GXP Share support external CMO/CLO partners? +
Yes. External partners receive an email invitation and access only the templates assigned to them. You control their role (submitter, reviewer, or read-only) and can revoke access at any time.
What export formats are available? +
PDF (with tamper-detection hash), CSV, and JSON. Bulk exports produce a ZIP archive. All exports include complete audit trails meeting 21 CFR Part 11 electronic records requirements.
How is data integrity enforced? +
Every submission, correction, and export action is logged with the user identity, timestamp, and reason. Original records are never deleted — corrections create a new version with a full diff. This satisfies FDA data integrity and audit trail requirements.
What does pricing look like? +
Pricing is based on the number of engagements and organizations. We work directly with each customer to find the right fit. Contact us for a quote — setup is typically hours, not months.

Ready to Transform Your Data Collection?

Join pharmaceutical companies eliminating paper forms and reducing errors. Setup takes hours, not months.

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