Our services:

 Qualification & Validation

        • Creating a new qualification and Validation documents or                          completion of available documents such as Validation plan, IQ,                  OQ,  HLRA, RA, System documentation, Traceability Matrix,                    Validation reports. Implementing User  periodic review, Change                 management, Incident management and DRP(Disaster Recovery               Plan)

    • Implementation of Qualification and Validation stand alone or
system Lab Testing Devices, such as analytic, galenic and
spectrophotometer according to defined quality guidelines
Pharmacopoeia, GMP, International standards and Regulatory
Affairs.

    • Implementing of automated computer system validation (CSV
Dissolution, Disintegration, Hardness ….etc) as well as
qualification and validation of Dissolution Software WinDiss32,
IDIS Version 3 fully automated system with Oracle data base
10g for data storage and management and for HPLC devices.

    • Creation of documents which supports cGMP compliance,
for laboratory testing equipment analytic, galenic and spectro-photometer and comparable quality management systems

    • Creating or adding to existing standard operating procedures

     (SOP’s)

     • Implementation of  Risk Mitigation Plan

Consulting:

        •   To support the creation of master plan for laboratory tests

        •   Supervision of technical documentation

        •   Collecting and testing of the required documents regarding
       permits and completeness

        •   Creating Systemdescription, user requirements specification, risk                analysis and Traceability Matrix 

        •   Participating in external vendor audit

        •   Coordination of training, qualification activities on site

        •   Supporting the implementation of  IQ, OQ and PQ tests

        •   Supporting the maintenance of qualified device condition or
            (Change Management)

Please if you need references, will be available up on requests