360˚ of Calibration & Validation Services
QATech offers a gamut of Calibration & Validation services for equipments & Clean room facilities based on the thorough understanding of cGMP standards. Services include,
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.
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