Quality Process Management

Micronova ICS specializes in QMS support, assisting our customers in meeting ISO, ICH, and GxP regulatory standards for optimal compliance and operational excellence. Our team offers customized solutions that enhance quality assurance across various industries.

• Contamination & Control Strategy (CCS): develop and enhance CCS to identify, prevent, and control contamination across facilities, equipment, processes, and personnel. It includes risk assessments, control design, monitoring approaches, and continuous improvement actions.
• Deviation & CAPA Investigators: expert support in investigating deviations and managing CAPAs to identify root causes, assess impact, and implement effective solutions. It includes deviation review, root cause analysis, risk assessment, CAPA planning, documentation, and follow-up monitoring.
• Process & Cleaning Validation: support to ensure operations consistently produce safe, high-quality results, to confirm process efficiency and reduce operational and quality risks. It includes validation planning, protocol development, execution, testing, documentation, and performance verification.
• Operational Quality Support: helps organizations maintain high standards across daily operations. It includes quality monitoring, process reviews, compliance checks, training support, and continuous improvement initiatives.
• Permanent Inspection Readiness Program: helps maintain organizations in a state of continuous inspection readiness. This includes gap assessments, process and documentation reviews, training support, mock inspections, and corrective action follow-up.
• Technical Writing & SOP writing: support to create clear, accurate, and compliant documentation for your operations. Includes drafting, reviewing, formatting, and maintaining standard operating procedures, work instructions, protocols, and technical manuals.