Intelilab structures and conducts qualification and validation work based on the object under analysis, its intended use, and the impact a failure may have on the operation.
The work may be needed when implementing a system, piece of equipment, environment, or process. It may also arise after a relevant change, a periodic review, or a problem that has called the validated state into question.
Before writing protocols, we define what will be evaluated and what evidence will be needed.
Depending on the operation, we can work on:
Scope is defined case by case.
Validation starts with the purpose of the system and the processes that depend on it.
The work may involve requirements, risk assessment, access controls, available audit trails and records, testing, deviation handling, and documentation of the conclusion.
Supplier involvement is considered according to the system and the evidence the supplier is able to provide.
In transportation, the design depends on the products, routes, vehicles, packaging, transit times, and environmental conditions involved.
Studies may require defining the worst case, monitoring points, acceptance criteria, and evaluation of the results obtained.
For the cold chain, the analysis also considers the stages in which the product remains in storage, is transferred, or is temporarily in transit.
Equipment and areas need to be evaluated according to the function they perform.
The work may include requirements, installation, operation, performance, calibration, maintenance, and criteria for use after relevant changes or interventions.
The protocol describes what will be tested. The conclusion depends on execution, the results obtained, the deviations recorded, and the final evaluation.
For this reason, the work needs to preserve the link between requirement, test, evidence, and conclusion.
Not every system, piece of equipment, or process requires the same amount of testing.
The strategy should consider function, criticality, available history, complexity, and the consequences of a failure.
Depending on the scope, deliverables may include:
Some work depends on measurement, calibration, mapping, testing, or technical services performed by a specialized supplier.
In these cases, Intelilab can organize the scope, requirements, and documentation of the work, while the specialized activity is performed by the appropriate service provider.
The division of responsibilities is defined before the work starts.
A significant change may require a new evaluation. The same applies to recurring failures, changes in use, relevant maintenance, or evidence that the expected performance is not being maintained.
The need for and extent of the new evaluation depend on the impact of the change.
Validation may arise as an action from an assessment, a Quality System review, or a controlled change.
The work is not defined by the name of the equipment alone. Its function, use, and the risks involved must be considered.
It depends on the scope. Some activities can be performed by Intelilab; others require a specialized company or professional. This division is defined in the project.
It is necessary to evaluate what has changed since execution, the current use, and the available evidence. The date of the document alone does not answer the question.
Describe the object and its intended use. From there, we define the scope of the work.