1.    Validation and GMP Areas

a.Equipment, Facility, Process, Cleaning, Methods
b.Protocol Templates – OQ Templates for Equipment, PLC’s, BAS, SCADA’s, …
c.Environmental Monitoring System
d.Revalidation Program
e.Evaluating the Manufacturing Processes
f. Evaluating Cleaning Processes
g.Laboratory Equipment Qualification System
h.Change Control Program
i. Sterilization & Sanitization Validation Plan
j. Environmental Controls and Facility Cleaning Guideline
k.Aseptic Processing Guidelines
l. Computer Systems Validation

Quality Systems
CAREERS   |
Quality Systems – Policies, Guidelines, and Procedures

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:
2.    Engineering, Commissioning, Facility Maintenance

a.Engineering Project Management System
b.Engineering Documentation Requirements System
c.Commissioning and Documentation Requirements System
d.Preventative Maintenance Program—Facility and Equipment
e.Maintaining Spare Parts Inventory
f.Calibration Program—Equipment and Instruments
g.Work Order Program


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