Process Support

Compliance Solutions

FAQ

Words and definitions


 
Process:
A systematic series of actions directed to some end: a continuous action, operation, or series of changes taking place in a definite manner.


Support:

To bear or hold up (a load, mass, structure, part, etc.); serve as a foundation for. To sustain or withstand (weight, pressure, strain, etc.) without giving way; serve as a prop for.


Compliance:

Compliance is either a state of being in accordance with established guidelines, specifications, or legislation or the process of becoming so.


Solutions:

The method or process of solving a problem.



Thermal Validation:

The term "thermal validation" is the process of validating equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for.


Calibration :

Calibration is the process of determining the error of indication of a measuring instrument. Calibration is performed by comparing the instrument against an instrument of a higher accuracy with a known error of indication. In popular terms, it can be said that "all measuring instruments are inaccurate, a calibration determines by how much" .



Qualification:

Qualification is an overall term used to describe the steps in the process of ensuring that an instrument or facility is suitable for use as intended. This process is applied prior to commissioning of new equipment, whenever components are replaced, during removal or when changes to the programming are made.


Maintenance:

Preventive measures or enhancements to process equipment that optimises its use.



cGMP:

'Current Good Manufacturing Practices' is a set of rules adhered to by pharmaceutical and biotech companies in order to ensure that production output meets specific requirements in terms of identity, strength, quality, and purity. The FDA and other authorities regulate these industries to ensure that cGMP are being followed.