Regulatory Compliance for Pharmaceutical Automation

Regulatory Compliance & Digital Quality for Pharma Digitalization and automation in pharmaceutical production must go hand in hand with regulatory compliance. HEITEC supports pharmaceutical manufacturers and machine builders in designing, modernizing and implementing automation and software solutions for regulated environments. Our approach combines technical expertise with a strong understanding of pharmaceutical requirements throughout the system lifecycle. Our services cover key regulatory and quality topics including: • Computerized System Validation (CSV) • Data Integrity and ALCOA+ principles • EU GMP Annex 11 – Computerised Systems • EU GMP Annex 1 – Manufacture of Sterile Medicinal Products • Annex 22 – Artificial Intelligence • User Requirement Specifications and risk-based approaches • Audit trails, electronic records and electronic signatures • User and access management • Qualification and validation documentation • Change control and lifecycle management With increasing digitalization, connected production systems and the introduction of AI-based technologies, regulatory requirements must already be considered during system architecture and solution design. HEITEC helps customers bridge the gap between automation, digital innovation and regulatory compliance – from initial concept and risk assessment through implementation, qualification and lifecycle support. Innovation is valuable. Compliant innovation is sustainable.