GMP, MDR, GDP, and supplier qualification – all regulatory requirements in one package. For pharmaceutical companies, medical device manufacturers, and suppliers.
Qualify suppliers according to EU GMP guidelines: centrally manage audit reports, GMP certificates, and Approved Supplier Lists with automatic monitoring.
Complete, tamper-proof audit trail with SHA-256 chaining – compliant with EU GMP Annex 11 and 21 CFR Part 11 for electronic records.
Monitor GMP certificates, ISO 13485, MDR conformity, and GDP approvals. Automatic alerts 90/60/30 days before expiry with escalation.
Good Distribution Practice for pharmaceutical distribution: temperature monitoring, transport validation, and supply chain documentation per GDP guidelines.
Record pharmaceutical supplier with manufacturing license, GMP status, and active substance classification.
Automatically verify GMP certificate, ISO 13485, GDP license, and manufacturing authorization.
Use the audit questionnaire for supplier audits. Document results in an audit-proof manner.
Add supplier to Approved Supplier List or initiate and track CAPA measures.
The Pharma Compliance Package is available from the Guard plan (79 EUR/month). Compliance Radar and Enterprise include multiple packages simultaneously.
Compare All PlansRegister for free and activate the Pharma Package. All documents, certificates, and audit questions are immediately available.
From Guard plan. GDPR-compliant. Made in Germany.