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Offering Full Turn Key Solutions to the Pharmaceutical & Bio-Technology Sector

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Rehadali Technology Limited can provide support full life cycle validation activities with an emphasis on the following activities:

 

Validation Master Plan (VMP)

 

A VMP will specify and co-ordinate all necessary qualification / validation activities for a site or project. Rehadali Technology Limited can help define and generate the required documentation in consultation with the client.

 

All validation activities are planned using the ‘V Model’ approach as follows to identify the relationship between the development and testing phases of the project ensuring that appropriate quality assurance and testing takes place throughout the project lifecycle:

 

 

 

 

 

 

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Design Qualification (DQ)

 

A DQ will verify the requirements of the user, especially GMP relevant requirements, are met by the system. Rehadali Technology Limited can provide a DQ package to ensure all user requirements are met.

 

Installation Qualification (IQ)

 

An IQ provides documented evidence that the system, as installed or modified, comply with the approved design and the manufacturers recommendations. Rehadali Technology Limited can provide a full IQ package for installations.

 

Operational Qualification (OQ)

 

An OQ provides documented evidence that the systems and sub-systems are capable of consistently operating within established limits and tolerances. Rehadali Technology limited can provide a full OQ package for an installed system.

 

Client Assistance for Performance Qualification (PQ)

 

A PQ is conducted to demonstrate compliance with all requirements under actual process conditions. Rehadali Technology Limited can provide assistance to the client in generating a full PQ package to meet their requirements.

 

 

 

Validation Master Plan Rehadali V Model

Validation

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