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MACHINERY REGULATION

(EU) 2023/1230

Is your documentation really ready for January 14, 2027?

Ready for the new Machinery Regulation?

From 2027 you can deliver machinery documentation digitally. QRcube helps you do it in a compliant and traceable way, with the paper version always available when needed.

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SDS – Safety Data Sheets

Delivering the sheet to the customer isn't enough: every update must be resent to all recipients supplied in the last 12 months. Missing an update: administrative fines up to €60,000.

Distribute SDS with no risk

With SDS Manager you send sheets to your customers, propagate updates to those who received them and keep proof of every transmission. Fully tracked, always compliant.

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Pharmaceutical Sector

Uncompromising GMP compliance

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

GMP/GDP compliant 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 Risk of using outdated versions of SOPs or specifications.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.

0%
Time saved
in audit preparation
0%
Traceability
on versions and approvals
Zero
Documentary findings
due to missing documentation
0h
Complete setup
of the digital quality system

How it works

A simple workflow to manage all GMP documentation.

01

Structure the archive

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

02

Tag documents

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

03

Monitor deadlines

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

04

Pass audits

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

Features for the pharmaceutical sector

Specific tools for GMP documentation and regulatory compliance.

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.

0+
SOPs managed
0+
Documents archived
-0%
Audit preparation time
The last AIFA inspection was the calmest ever. Zero documentary findings for the first time.Dr. Anna Bianchi, Quality Director

Ready to simplify GMP compliance?

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