Industriële panel-pc's voor farmaceutische productie en GMP-conformiteit

GMP Requirements for Industrial Computing

Good Manufacturing Practice (GMP) regulations, enforced by India's CDSCO, the US FDA, and the EU EMA, impose strict requirements on computer systems used in pharmaceutical manufacturing. These include:

• 21 CFR Part 11 (US FDA), electronic records and electronic signatures; audit trail of all operator actions
• EU Annex 11, computerised systems validation in pharmaceutical manufacturing
• WHO GMP, data integrity and computer system validation requirements

Physical Requirements

• Stainless steel enclosure, 316L SS for product-contact zones; smooth surfaces, no crevices
• IP65 minimum, for washdown and cleaning validation procedures
• Cleanroom compatibility, smooth surfaces, no particle-shedding components, no exposed vents
• Minimal bezel, reduces surface area for contamination accumulation

Software and Validation Requirements

• User access control with role-based permissions (operator, supervisor, administrator)
• Electronic audit trail, timestamp, user ID, and reason for every parameter change
• Electronic batch records, digital replacement for paper batch records
• IQ/OQ/PQ validation support, hardware must be stable and qualifiable

Choosing Pharma-Grade Industrial PCs

For Indian pharma manufacturers, whether API producers, formulation plants, or medical device manufacturers, TSL Automation supplies Avalue stainless steel Panel PCs and GMP-ready industrial computers. We can provide hardware validation documentation to support your IQ/OQ qualification activities.