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Validation Protocol Execution Tips – Top 10

1. Ensure that the protocol has been written from an approved design document. There’s

no point in developing tests from an unapproved FS (Functional Specification) or DS

(Design Specification) if the design is going to change. Your protocol needs to reflect

what is in your approved design document.

2. The person who is developing the protocol needs to understand what needs to be

tested.

3. Ensure that you have sufficient time before you run the protocol to dry run it.

4. Treat the dry run as a real run, document all of your test results like you would the real

run (You’ll be surprised what you find!)

5. If you have time, get an independent person to review your protocol, they will spot

things you will never see.

6. Start the execution at the start of your day when you are fresh, not at the end when you

are rushing and want to go home.

7. Ensure that all of the prerequisites have been performed before execution

8. Have deviation and discrepancy forms at hand to write them up as you go along (You

will forget the details if you don’t)

9. Understand what is the difference between a deviation or a discrepancy (Or whatever

terminology your company uses)

10. Attach any evidence you deem important


QUALIFICATION & VALIDATION

Qualification is a process of assurance that the specific system, premises or equipment


are able to achieve the predetermined acceptance criteria to confirm the attributes what it
purports to do.
Validation is establishing a documented evidence to provide a high degree of assurance
that a specific system, process or facility will consistently produce a product meeting its
predetermined specifications and quality attributes.

Qualification is documented evidence that a specific equipment, facility or system is


fit/ready for intended use.
Validation is documenting that the way equipment, facility or system used will result in
product meeting its predetermined specifications and quality attributes.

Things are qualified: equipments, systems etc.


Process/Procedures (the way we use things) are validated.

Before you do validation on a process, you have to be sure that the equipment has passed
qualification

Globaly....yes, you can say like that, but...perhaps is better to say..calibration is one of
condition to make qualification, as well as qualification is one of condition to make
validation.
Also, don't forget..this is important and very clarify (from the first post)..

''Things are qualified: equipments, systems etc.


Process/Procedures (the way we use things) are validated.

Before you do validation on a process, you have to be sure that the equipment has passed
qualification.''