Delivering Compliance
An ISO 9001 : 2008 company
Temperature Mapping
Ware House Temperature & Rh Monitoring
Autoclaves, sterilizer temperature mapping
Dry Heat sterilizer, Ovens temp mapping
Incubator, cold room temperature mapping
GMP Consulting
Validation Services
GMP Compliance Audits
Risk Assesment
Supplier & Contractor Audits
Training
Cascade Impactors
Calibration
Offering a comprehensive
calibration service that can be tailored to your
requirement.
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PLC Validation
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems was launched on 28th February 2008.
The release of GAMP 5 aims to provide guidance on regulatory compliance through cost and time effective methods and signifies a period of transition of new ideas with a more innovative approach to compliant systems.
GAMP 5 relies heavily on Risk Assessments and to put it in to context, ICH Q8, ICH Q9 and ICH Q10 as well as ASTM 2500 must be read and understood.
Experience
QATECH staff are experienced in the validation of PLC and SCADA systems, of various industrial facilities
We can provide operational resources and assistance with the generation of User Requirement Specifications (URS), through Commissioning and Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
We are able to assist in the Development of the VALIDATION MASTER PLAN and executing it accordingly
