Engineering / Commissioning / Maintenance

Supporting the Validation Process is important and needs programs that may include a series of procedures to coordinate a process. Our compliance consultants are specialized in many areas and have developed many programs for implementation. Some examples are listed below:

Engineering Project Management System
Engineering Documentation Requirements System
Commissioning and Documentation Requirements System
Preventative Maintenance Program-Facility and Equipment
Maintaining Spare Parts Inventory
Calibration Program-Equipment and Instruments
Work Order Program



Validation and GMP Areas

Equipment, Facility, Process, Cleaning, Methods
Protocol Templates - OQ Templates for Equipment, PLC's, BAS, SCADA's, ...
Environmental Monitoring System
Revalidation Program
Evaluating the Manufacturing Processes
Evaluating Cleaning Processes
Laboratory Equipment Qualification System
Change Control Program
Sterilization & Sanitization Validation Plan
Environmental Controls and Facility Cleaning Guideline
Aseptic Processing Guidelines