Arizona Automation & Technology

IT-GxP & IT-ADMINISTRATION SUPPORT

User Management, Backup & Periodic Restoration, Preventive Maintenance, Inventory Management of GxP Computerized Systems, IT QMS related SOPs, IT Infrastructure Configuration, Server Configuration & Validation, Network Configuration, Cloud System Validation.

REGULATORY & COMPLIANCE SUPPORT

Help to achieve and review various activities related to Quality Management System
Provide Pre Audit and Post Audit support for various Audit like USFDA, PIC/S, EU-GMP & WHO.
We can have carried out FAT and SAT activity.
Review various documentation, Systems, Equipment’s and Facilities as per client recommendation.
Design Various GxP SOP to achieve compliances:
- Disaster Management SOP
- CSV Validation
- Environmental Control
- Various Compliance SOP’s
for GAMP 5 as a core with regulatory services as per USFDA, EUGMP, WHO or PICS which includes:
- Assessment of: GAP, Impact, GxP and Risk assessment
- Audit trail review
- IT infrastructure review System &Utility review as well as Documentation review
- Data storage, backup, restore, analysis and recommendation
- Disaster Management solution
Highly expertise Team of CSV, QbD and DI
Highly expertise team of QMS, IT-QMS, IT-GxP, IT-Administration
Highly expertise team of Automation and MES system
Highly expertise team of GMP Consulting

CLEAN ROOM / HVAC VALIDATION

We understand the importance of Cleanroom conforming to regulatory standards including: ISO 14644:2015 and guideline agencies such as MHRA, FDA, EU GMP, WHO-TRS-961, WHO-TRS-937, and Schedule M for all room classification.

Arizona Automation & Technologies has expertise not only in Pharmaceutical cleanroom but Operation theater, Laboratory, and Various equipment like Bio-safety cabinet, Laminar Flow equipment, Fume cupboard, Local Exhaust Ventilation (LEV) system or relocation of equipment.

Classifying your cleanroom:

We understand the various Cleanroom classification and can advise on yours. Facility design for Pharmaceuticals development or manufacturing, need to confirm to either CGMP and/ or ISO 14664-1,2,3:2015 All cleanrooms have a classification which is determined by the concentration of Airborne particles, ranging from 0.1μm and macro particles which are larger than 5 μm are not covered within this range, however more information on particle sizes are available on request.

AAT carried out following cleanroom/ HVAC validation tests and provide Certification accordingly:

GxP Assessment and System Categorization
Validation Plan
User Requirement Specifications
Risk Assessment
Functional Design Specification

Performance Qualification
Validation Summary Report
Traceability Matrix
System Release Certificates
Periodic Review Report

TEMPERATURE MAPPING / THERMAL VALIDATION:

Arizona Automation & Technologies offer a wide range of Temperature Mapping and Thermal Validation services that can be tailored to suit individual requirements and produce cost effective, fast and accurate validation results.

Arizona Automation & Technologies hold impressive equipment inventory and can quickly respond to service requests involving large amounts of test points. Our validation engineers are trained enough to provide fast project turnaround.

Arizona Automation & Technologies having specialization to qualify:

Cold storage, Warehouse and Room temperature mapping.
Fridge, Freezer.

Washer Disinfectors.
Traceability Matrix
System Release Certificates
Periodic Review Report
Assessment of: GAP, GXP, Tittle 21 Part 11, Impact

Drier, Oven, Furnace.
Incubator.
Autoclave and Sterilization.
Stability Chamber.
Lyophilizer.

UTILITY VALIDATION:

The Utility Qualification is the process of providing with high level of confidence that a device is able to operate consistently within the limits and tolerances which will be required during the production process.

Documented impact assessment should be performed on all utility systems like Water, Steam, Air, Nitrogen, HVAC and other. Those that have impact on product quality should be appropriately qualified in accordance with Good Manufacturing Practice (GMP).

Equipment Validation

Equipment Qualification is an essential factor for ensuring Pharmaceutical drug safety and our support is extended to provide FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) for any Equipment or Process and to prepare various SOP, or any other quality documentation support.

Arizona Automation & Technologies holding overall responsibilities as a regulatory environment usually require equipment to undergo qualification. Our well trained and qualified engineer performed recommended qualifications that meet regulatory requirements. Our Risk based approach enables us to leverage many years of industrial experience. We provide you cost effective and timely solutions.

Our Qualification Services:

Delivery inspection, complete installation and testing of your equipment.
Monitoring of the environmental conditions at the installation site.
Functional tests according to the instrument specification.
All finding documents in GMP compliant qualification template.

Pharmaceuticals manufacturing industries need Equipment Qualification because this exercise is a method of establishing document evidence that shows the high degree of assurance that our manufacturing process will consistently yield a product of predetermined quality. For this client we need our involvement in the DQ, IQ, OQ, PQ process.