DATA INTEGRITY COMPLIANCE

We support your company's risk based strategy to prevent and detect data integrity potential issues as required in 21 CFR Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals.

Our data integrity assessment process begins with a gap assessment of each system/instrument to verify capabilities to restrict alteration of specifications, process parameters, or manufacturing or testing methods.  

Once we have a gap assessment we proceed with method recommendations to achieve a robust data integrity for each individual system and overall company strategy, including defining the system administrator role (rights to alter files, personnel access assignment, creating and maintaining a list of authorized individual(s) with their access levels and rights for each cGMP computer system

Once agreed on a data integrity control method and mechanism we support method support the mapping of computer system workflow testing, SOP generation and validation, as required in 21 CFR Current Good manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals.

 WE ENSURE TRACEABILITY AND ROBUST DATA INTEGRITY CONTROLS BASED ON INDUSTRY'S ACCEPTABLE METHODOLOGY