Pharmaceutical Risk Management — GMP, GDP, ISO 13485
Manage pharmaceutical production risks with an integrated platform. GMP, GDP, ISO 13485 compliance. Pharmacovigilance, supplier qualification and process validation in a single solution.
Specific Risks in the Pharmaceutical Industry
The pharmaceutical industry operates under the world's strictest regulations. A single error can compromise patient health and lead to multimillion-pound penalties
Product Recall
Risk of pharmaceutical batches being withdrawn from the market due to process deviations, contaminations or GMP non-conformities, with enormous costs and warning letters from regulators
Product Liability
Risk that manufactured drugs cause harm to patients with consequent civil liability, market withdrawal and criminal implications for executives
Critical Supplier Loss
Risk of disruption to the supply of active pharmaceutical ingredients (APIs) and raw materials due to loss of a GMP-qualified supplier
Sensitive Data Theft
Risk of theft of research data, proprietary formulations, registration dossiers and clinical data, with breach of data integrity and ALCOA+ requirements
Paper-based deviation management with unacceptable CAPA closure times.
No guaranteed data integrity with untraceable manual records.
Poorly monitored API suppliers with pharmaceutical supply chain risk.
Reactive change control without structured impact assessment.
Digitalised deviations with CAPA workflow and controlled timelines.
ALCOA+ audit trail on every data point and document in the system.
GMP supplier qualification with audits, scoring and continuous monitoring.
Proactive change control with automated impact assessment.
Features for the Pharmaceutical Industry
Specific tools for managing pharmaceutical production and distribution risks
Quality Risk Management
ICH Q9-compliant risk analysis: FMEA, FTA, pharmaceutical HACCP. Structured risk assessment for processes, products and systems with scoring and mitigation.
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Deviations and CAPA
Complete deviation cycle management: identification, classification, root cause analysis, CAPA, effectiveness verification. GMP-compliant approval workflow.
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Change Control
Change management with automated impact assessment on quality, regulatory, validation. Multi-level approval workflow and implementation tracking.
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GMP Supplier Qualification
API, excipient and packaging material supplier qualification and audit. GMP questionnaires, audit planning, risk scoring and Quality Agreement management.
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Audits and Inspections
Internal GMP audit management, self-inspection, supplier audits and regulatory inspection preparation. Pre-configured checklists and observation tracking.
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Product Quality Review
Automated PQR with batch record data collection, trend analysis, statistical review and improvement action identification. GMP Annex I compliant.
Learn moreHow Pharmaceutical Companies Use Exsafe
Concrete application scenarios in the pharma and medical devices sector
Sfida
A pharmaceutical company had to proceed with the voluntary recall of 3 batches of an antibiotic due to a process deviation not intercepted in time. The paper-based deviation management system had not generated alerts and the CAPA had been open for 90 days. The recall incurred direct costs of EUR 320K and an urgent communication to the regulator.
Soluzione
The risk analysis with Exsafe Platform identified excessive CAPA closure times and the absence of a link between deviations and distributed batches as the main causes of avoidable recalls, and proposed digitalisation of the process with alert escalation. The company chose to implement automatic deviation classification by criticality, structured root cause analysis and a direct link between deviation, production batch and distribution.
Risultato
Average CAPA closure time reduced to 35 days. No recalls in the 18 months following implementation. Regulatory inspection passed with 0 critical observations on deviation management.
Results in the Pharmaceutical Industry
The numbers from pharmaceutical companies that chose our solution
Corrective action closure
Resolved and prevented
Verified effectiveness rate
ALCOA+ compliance
Pass every regulatory inspection with complete and traceable documentation
Reports ready for GMP inspections, client audits and ISO 13485 certifications. Guaranteed data integrity.
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Frequently Asked Questions - Pharmaceutical Industry
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