Pharma

Pharmaceutical compliance combining MDR/IVDR requirements, Good Manufacturing Practice (GMP), with cybersecurity and protection of clinical data.
Compliance with MDR and IVDR regulations for medical devices
Protection of clinical trial and research data
Cybersecurity of manufacturing systems (NIS2)
GMP (Good Manufacturing Practice) and GxP requirements
Comprehensive management of regulatory documentation
Protection of intellectual property and research data against industrial espionage

Relevant regulations

Cybersecurity

NIS2

Cybersecurity Directive

Directive establishing cybersecurity requirements for the pharmaceutical industry.
Healthcare

MDR

Medical Devices Regulation

A European regulation laying down requirements for the safety and documentation of medical devices.
Healthcare

IVDR

Regulation on Medical Devices for in Vitro Diagnostics

Regulation on in vitro diagnostic devices with requirements for validation and quality management systems.
Standards

ISO 9001:2015

Quality Management System

Standard for quality management, relevant for organizations with high demands on process quality.
Standards

ISO 27001

Environmental Management System

Information security management standard, relevant to data protection in the pharmaceutical industry.
Standards

ISO 14001:2015

Environmental Management System

Standard for environmental management, relevant for organizations with an emphasis on sustainability.

How Regfor helps

  • Analyst

    Interpretace požadavků MDR, IVDR, GMP a dalších regulací s ohledem na specifika farmaceutického odvětví.

  • Architect

    Systematické plánování a sledování implementace opatření podle regulatorních požadavků.

  • Inspector

    Průběžné kontroly a audity stavu implementace opatření a připravenosti na inspekce.

  • Investigator

    Detailní prověřování dodavatelů s důrazem na řízení rizik dodavatelského řetězce.

  • Riskman

    Komplexní řízení rizik včetně hodnocení kritických procesů a závislostí na dodavatelích.

  • Data Vault

    Bezpečné úložiště pro regulatorní dokumentaci a auditovatelné záznamy připravené pro kontroly.

  • Watchdog

    Nepřetržité sledování dodržování požadavků napříč výrobními linkami a laboratořemi.

Use case

A medical device manufacturer with production plants, development centers, and subsidiaries uses regfor for centralized compliance management with MDR, IVDR, and NIS2 across the entire group.

The team interprets regulatory requirements using ANALYST, plans measure implementation through ARCHITECT, stores technical documentation in DATA VAULT, and manages risks with RISKMAN.

Thanks to centralization in regfor, the manufacturer has a consistent overview of compliance status across all production sites and laboratories and can coordinate team activities across departments when preparing documentation for notified bodies and regulators.

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