Medical Device Process Validation | Operon Strategist

from Pune
4 years ago

medical Device Process Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages.

In simple words, the process validation is the collection and evaluation of data, from the process design stage till the production, as it gives scientific evidence that the process is capable of consistently providing quality products.

Medical Device Process Validation services:

Medical Device Process Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation.

Validation of a machine or a process is carried out to ensure that products of consistent quality are manufactured and the required level of compliance is met at every stage.

Since a wide variety of procedures, processes & activities need to be validated.

Medical Device Process Validation is divided into the following sub-sections:
  • HVAC validation
  • Equipment validation
  • Process validation
  • Facilities validation
  • Cleaning validation
  • Analytical method validation
  • Personnel validation
  • Packaging validation
  • Computer system validation

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