Pharmaceutical Sector

Organised and traceable GMP documentation

Manage GMP documentation, batch records, and supplier qualifications. Everything organized for FDA, EMA audits, and regulatory inspections.

Request a demo Speak with an expert

Organised GMP documentation Complete audit trail Controlled versioning

Document management for the pharmaceutical sector

Challenges of document management in pharma

In the pharmaceutical sector, documentation is mission-critical. Any non-compliance can have severe consequences.

Complex documentation

SOPs, batch records, qualifications, and validations scattered across different systems. Difficult to keep everything aligned.

Demanding audits

Days of preparation before each inspection. High stress and risk of findings due to incomplete documentation.

Critical versioning

Documents under continuous revision. Risk of using outdated versions of SOPs or specifications.

Supplier qualifications

Certifications and supplier audits need constant monitoring. Deadlines slipping out of control.

How Certiblok solves these problems

A platform designed for the specific needs of the pharmaceutical sector.

Structured GMP archive

SOPs, batch records, validations, qualifications. Ready-to-use GMP structure with templates and categorization.

Automatic expiry alerts

Proactive notifications for SOP revisions, supplier qualifications, calibrations, and certifications.

Controlled versioning

Every document has its version history. Always clear which is the current approved version.

Qualified supplier management

Supplier master data with all linked certifications and audits. Everything tracked.

Concrete results for pharma companies

Measurable benefits in quality documentation management.

85%

Time saved

in audit preparation

100%

Traceability

on versions and approvals

Zero

Documentary findings

due to missing documentation

< 30 min

Complete setup

of the digital quality system

How it works

A simple workflow to manage all GMP documentation.

Structure the archive

Create the GMP document structure: SOPs, batch records, validations, supplier qualifications.

Tag documents

Associate each document with the product, process, or supplier. Everything organized and retrievable.

Monitor deadlines

Set alerts for SOP revisions, qualifications, and certifications. Never miss a deadline again.

Pass audits

Find any document in seconds. Demonstrate compliance with history and traceability.

Features for the pharmaceutical sector

Tools to organise GMP documentation. Validation of the system under Annex 11 remains the company’s responsibility.

SOP Management

Standard Operating Procedures with versioning, approvals, and controlled distribution.

QRCube® on equipment

QR on equipment for immediate access to qualifications, calibrations, and maintenance records.

Expiry alerts

Automatic notifications for SOP reviews, supplier qualifications, and expiring certifications.

Decentralized backup

All documents securely saved with automatic backup and geographical replication.

Who uses Certiblok in pharma

Measurable results in real pharmaceutical companies.

PharmaTech S.p.A.

Pharmaceutical production

The challenge. Stressful AIFA inspections, fragmented GMP documentation across different systems, recurring risk of documentary findings.

The solution. Structured GMP archive with controlled versioning and expiry dashboards. Complete immutable audit trail.

500+

SOPs managed

15.000+

Documents archived

-90%

Audit preparation time

The last AIFA inspection was the calmest ever. Zero documentary findings for the first time.— Dr. Anna Bianchi, Quality Director

Frequently asked questions

How does Certiblok help pharmaceutical companies?

Certiblok gathers in a single platform the documents that pharmaceutical companies manage and share every day: GMP documentation, batch records and validation dossiers. Every file keeps a complete version history, with upload date and time and the author of every change, so you can reconstruct which version was in use at a given moment.

Which Certiblok modules do pharmaceutical companies use most?

The most used modules are Audit Room, DRM® & Archive and VaultCube®. They work on the same archive, with versions, history and access logs shared across modules.

Is documentation shared with customers, auditors or authorities traceable?

Yes. For every share the platform records who opened the document, with date and time, and shows you the recipient's opening and read confirmation.

How is my data protected?

Documents are encrypted and distributed across a decentralised storage network, with nodes in the European Union for European customers. Certiblok S.r.l. operates an information security management system certified to UNI CEI EN ISO/IEC 27001 and processes data under the GDPR.

Ready to simplify GMP compliance?

Speak with one of our pharmaceutical industry experts to confidently pass audits.

Book a demo Speak with an expert