Standard Operating Procedures (SOPs)
Design & Engineering
Mechanical Design
Rapid Prototyping
Reverse Engineering
FEM Simulation
Quality and Validation
Quality System Support
VMP - DQ IQ OQ PQ Validation
Standard Operative Procedures (SOP) (IOP)
Technical File / Design Dossier
Design Control
DHF Design History File
Risk Management Process
Clinical Evaluation
Testing
Mechanical Testing
Analysis on Plastics
Biological Safety Evaluation
We can support Your Company with the aid of proper Gap analysis of process, manufacturing, and operations activities in the definition of specific procedure aimed to control the process and assure the conformity to GMP requirements.
Standard Operating Procedures (SOPs) are an indispensable tool to demonstrate that a process is under control at all stages.
The actions taken must be documented and conducted according to the procedures set.
For an inspector is not enough to report that a given activity is carried out in a specific way: we need to prove it!
The presence of detailed procedures, clear and intuitive optimizes the business.
This reduces setup time and execution of activities thus reduce the associated costs.
It speeds up the training of the operators.
You shall ensure that operations are conducted in a repeatable manner.