ABOUT US
Air Care Zone is a nationally recognized independent agency approved by ISO 9001:2015 providing consultation & services in the area of regulatory compliance.
We are the pioneers of validation services in India and we offer various services to major pharmaceutical companies across the globe.
Our portfolio of services encompasses the entire product life cycle and includes GMP Compliance Services, Validation Services and projects requiring the integration of
both these services.
Our dedicated validation and automation division are uniquely qualified to optimize any validation effort by applying quality
validation services and the most current technology.
We cater to the following compliance and business requirements:
Documentation and Validation:
- Comprehensive GAP & RISK Analysis
- Most appropriate & latest GAMP, 21 CFR Part 11, EU Annex 11 guideline based compliance services for your new/ legacy systems
- Facility Qualification
- Equipment Qualification
- Validation of Laboratory Equipment Software, IT systems, Network validation as per GAMP
- Validation of Building Management & Environment Control Systems
- Validation DCS / SCADA / PLC Based Systems
- LIMS Validation and Implementation
- SAP-ERP Validation and any type of global IT application validation
- Spreadsheet Development and Validation as per 21 CFR Part 11 requirement
- HVAC Validation
- Compressed Air, Nitrogen System, Pure Steam System Validation
- Temperature Mapping of area and equipments
Instrumentation and Automation:
- Annual Maintenance Contract for your PLC based automated systems
- PLC/ DCS Troubleshooting
- Turnkey Automation Solutions
- Customized software development to automate your manufacturing/ testing process