Sections

Validation

Your validation process: planned and assisted by Lindeq and partner

In today’s highly regulated GCP and GPvP environments, systems and processes need to be validated against high standards. This is a critical point in the GCP and Pv inspections carried out by national Competent Authorities as well as by the European agency, EMEA. In the lifecycle management of any regulated system, the initial and documented validation must be followed by similarly documented change control procedures in the ongoing use and administration of such systems. By no means is this a small effort. However, apart from satisfying agency inspectors, you do get the solid benefits of knowing that you operate a fully GxP validated and controlled system. This, in itself, is a valuable asset representing a sound investment.
Together with our partner GXP International (Dr Teri Stokes) we can help you planning your validation process and assist your validation team. We can help you streamline your system SOPs ensuring ongoing change control measures which will see to, that you maintain your GxP validation status – also 2,3 or 4 years after taking a system into production use.
 
To get to know your regulatory needs and requirements, to supply you with further information, please feel free to contact us.
 
 
Document Actions