SQ (Specification Qualification)
is the step that provides the foundation for the whole validation process. The essential part of this step is the creation by the user of a Requirements Specification for the system or process to be validated. Wherever possible, the main points specified should be capable of being objectively tested. Loose specifications such as "reasonably fast", ""state of the art" or " fairly accurate" are unacceptable for the purposes of validation since there are no objective criteria against which they can be tested. FDA guidelines recommend that the validation department should verify that the Requirements Specification is in close agreement with the supplier's Requirements Specification for a system since this provides a degree of assurance that the aims of the validator coincide closely with those of the supplier.
CQ (Construction Qualification)
is the step by which it is shown that the system conforms to the design specifications. This step is accomplished by the supplier providing the test certificates produced during manufacture of the system. In some cases, users find that a well written OQ procedure will provide satisfactory evidence that the system conforms to the manufacturers design specification.
IQ/OQ
Essentially these paired validation steps answer the questions "Is the instrument complete and ready to operate?" and "Is the system exactly the same as when it left the factory?"
IQ (Installation Qualification)
is essentially a Product Setup qualification which checks that the correct items have been delivered, that the site requirements for the system have been met and that they the system is functional.
OQ (Operational Qualification)
determines that the system performs against a specification both in terms of functional tests performed on individual components of the system and as well operational tests of the whole system. In the case of the Mastersizer 2000, these operational tests include the measurement of various size standards to determine that the correct size values are reported within specified tolerances.
PQ (Performance Qualification)
This qualification step is the final step in the qualification of the system. The performance qualification consists of a series of checks by the user against the original Requirements Specification for the system. For example, if a Mastersizer 2000 was purchased to measure lactose in the size range 10 to 300 µm in the dry state, then this step will essentially be a series of tests to prove that this key specification point has been satisfied.
ISO13320
ISO13320 is a guidance document that clearly describes the principles of LALLS, defines terminology and explains what to expect from an instrument of this type. Sample handling and dispersion, guidance on the use of dry powder feeders, information on error diagnosis and a discussion of Mie theory versus the Fraunhofer approximation are all included.
Escrow
Many suppliers of complex systems offer escrow licenses which give licensees an ultimate right of access to the software source code and development tools in the event that the supplier is unable to continue supporting the software.
Although this offers useful protection where the continuing operation of a large production facility needs to be assured, it is now considered by Malvern users to be an excessively high cost solution to a low risk situation and, as a result, Malvern Instruments’ software is no longer held in escrow.
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