Take the ISO 13485 course exam and get the
ISO 9001 course exam for free
LIMITED-TIME OFFER – ENDS SEPTEMBER 29, 2022

Expert Advice Community

Guest

Creating validation report

  Quote
Guest
Guest user Created:   Oct 21, 2021 Last commented:   Oct 23, 2021

Creating validation report

how to create validation report for new machine used at production floor?
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Oct 23, 2021

The Validation procedure for the new machine consists of the following elements: installation qualification, operational qualification, and performance qualification. The purpose of the validation is to prove that the new machine works correctly and  provide accurate and expected results. Installation qualification confirms that the exact required equipment has been received and installed, in the correct design or format in undamaged form with parts, spare parts, gauges, and other necessary elements. Operational qualification ensures that the installed equipment will function in accordance with all its operational specifications in the specified environmental conditions. Performance qualification ensures that the installed equipment consistently performs its functions in accordance with the specification corresponding to its daily/routine use.

For each validation, you need to have a validation plan and validation report. Validation report must have the following elements:

  • It must identify the impact of each piece of equipment on the product
  • Identifiy the risk that equipment have on the final product
  • Document which SOPs are used, calibration equipment, etc.
  • Have to have all criteria defined what is acceptable and what is not
  • All test results that were performed during the validation process<
  • Photos are always a good way of proving that you have performed something – like a photo of the screen on the equipment that reflects the conditions of the process and so on
  • Criteria when the revalidation will be performed

For more information, see:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Oct 21, 2021

Oct 23, 2021

Suggested Topics

Guest user Created:   Apr 18, 2022 ISO 13485 & EU MDR
Replies: 1
0 0

Dental burs

Guest user Created:   Mar 28, 2022 ISO 13485 & EU MDR
Replies: 1
0 0

Management review questions