Regulatory agencies pay a special attention to compliance of QC and Microbiological Laboratory, and Life Sciences companies are frequently concerned about their compliance status.

K2C staff provide a full service that covers these compliance concerns, thay may include the quality system, the validation of instruments or computerized systems, the calibration and maintenance of the same.

K2C services dedicated to Laboratories include:

 

        Laboratory Process Design, including all appropriate procedures

        Laboratory Compliance Assessment and Risk Analysis/Management

        Assessment on special issues (i.e. 21 CRF part 11)

        Training according to specific needs

        Definition of process and system Requirements

        Validation of instruments and computer systems

        Calibration planning and execution, by appropriate maintenance contract

        Preparation to regulation agency inspections

        Validation of Cleaning Methods

Contact us for more information.