• Validation/qualification policies, procedures, protocols, and master plans
• Technology transfer programs including processes, analytical methods, and project management
• Staff training for ongoing validation programs

• Validating/qualifying computerized systems and electronic records
• Validating analytical methods
• Qualifying analytical equipment

Development and/or implementation of:

• Validation of process, equipment, instrumentation, analytical methods, utilities, facilities and computer applications
• Risk-based validation strategies
• User requirements, functional and design specifications
• Protocols, reports and test cases for IQ, OQ, PQ
• Data migration and verification
• ER& ES; 21 CFR Part 11 System compliance assessments and training
• Analytical methods validation in order to specific requirements

Hyper care for systems and processes affecting validation, including:

• Change Management
• Configuration management
• Retrospective validation
• Electronic signature certification and policy
• Periodic reviews of the GxP related areas
• Data integrity assessments for electronic records

Qumits consultants assists clients in:

• Evaluation/Optimization and preparation of policies and standard operating procedures
• Assessment/Optimization and development of the quality system (QS)
• Assist  to interpret regulations in performance and operation with industry standards
• Setting up and effecting Root Cause Investigation, Corrective and Preventive Action (CAPA)
• Planning and Training to meet current FDA expectations for GxP Compliance
• Handle the Quality System and Operation of the Plasma collection centres and prepare them for the European authority inspections (Regierungspräsidium in DE, etc)

Qumits commercial providing:

• Finished Pharmaceuticals (Generics, Biosimilars and Brands)
• Human Plasma for Fractionation (Fresh Frozen Plasma) 
• Veterinary Medicines