Migration testing data required

Migration (mg/kgjbod simulant) Test data requirements... 

The OQ protocol is executed once the system has been loaded with the operational data, accepting that a final data migration may be required to capture updates occurring during the test period. This process may often be referred to as "conference testing" or the "conference room pilot". 

The migration project is divided into the well-known phases of software development requirements analysis and specification, design and build, acceptance tests and productive go-live (Fig. 16.4). The acceptance test phase differs from the common software development cycle. It sphts into a phase of small batch tests which proofs the implementation to be compliant with specification and requirements and a test phase, which may be performed repeatedly or which may iterate over improvements of the specification, implementation and test phases. The tests try to identify the impact of the implemented migration solution on the complete source data set considered for migration. This approach requires a full dump of the source data to a separate stage solely dedicated to the test phase. This step proofs the assumption of the requirements phase to be correct and helps to identify anomalies or unexpected data in the source database. Thus, all data considered for productive migration need to be taken into account. The user acceptance test is... 

Design of an air sparging system requires a balanced airflow to maintain effectiveness and control of the migration of fluids and vapors. Because of the potential for loss of control, an air sparge system should not be designed or installed without a field pilot test. Design data from pilot tests include ... 

Conditions migration data (ppm) Toxicological tests required by the SCF Usual decision of the SCF... 

Initially, a single test script under the Analyst validation was envisioned. However, as the complexity of the MassChrom software versions was understood, a data migration and system retirement test plan was required to explain the overall strategy with five test scripts. Further information gathering revealed more complexity, and the number of test scripts rose to 10. 

A complicating factor was that each combination of MassChrom software had been validated on its own but comparison of data across all combinations of the software had not been imdertaken as this is not normally considered as part of a normal validation stndy. Therefore, to ensure a comprehensive approach to the data migration, an evalnation of data aeqnired by all MassChrom software versions was required to ensure that no regnlatory qnestions remained with the data migration. This approach increased the number of test scripts to 16. 

Brown s statistical theory [30] of annihilation of screw dislocation dipoles by thermally activated jog migration determines the PSB nanostructure and the saturation stress. The statistical theory is compatible with the nanotheory and the required activation energies are available for both cross-slip and jog motion in copper, as described in 2.2 and 2.3. What remains is to combine and quantify the above theories of thermally activated fatigue hardening, PSB nucleation, cyclic saturation and PSB surface damage to test their quantitative predictions against experimental data. 

For solid products the risk of migration is low and therefore interaction studies are not required over and above the normal stability test results. For semi-solid products it is necessary to look particularly at the migration of additives, vapour permeation and the effects of the product on the physical parameters of the pack. For liquid products the migration potential for the specific formulation is required, and the determination of active ingredient content under simulated use, along with extractives data is required for parenteral and ophthalmic products. Moisture permeation is important, particularly for solid products packaged in blister packs. 

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