Our services:
• Implementation of Qualification and Validation for stand-alone system or server based system (Lab Testing Devices, such as analytic, galenic and spectrophotometer) according to defined quality guidelines Pharmacopoeia, validating quality control system in lab, (GMP, International standards and Regulatory Affairs.
• Implementing of automated computer system validation (CSV) and qualification of Dissolution, Disintegration, and Hardness ….etc.)
• Creation of new or adapting available qualification documents which supports cGMP compliance, (analytic, galenic and pharmaeutical and biotechnology manufacturing) and comparable quality management systems

• Creating qualification/validation documents for Design Qualification, Validation plan/report, Installation Qualification, Operation Qualification and Performance Qualification based on customer SOP
  

• Creating User Requirements Specification, Risk Analysis, Traceability matrix
  

• Creating or adding to existing standard operating procedures (SOP’s) and manuals
• Process definition based on working instruction and its life cycle documents (FMEA, Validation Plan/report...etc.
• Creating GxP assessment
  
• Creating ER/ES assessment
  
• Validation of Excel spreadsheet
  
• Execution periodic review
• Qualification of supplier
  
• Data integrity, Data Mapping and their risks definition
  
• Creating test case and execution
  

Consulting:

• To support the creation of a master plan/report for laboratory test equipment
• Supervision of technical documentation.
• Collecting and testing of the required documents regarding permits and completeness.
• Coordination of training, qualification activities on site.
• Implementation of IQ, OQ and PQ tests.
• Supporting the maintenance of qualified device condition or (Change Management).

• Supporting periodic review execution.