Intelilab analyzes manufacturing processes, records, deviations, changes, qualification, validation and other controls defined in the scope of work.
The work can start before an inspection, during a Quality System review, in preparation for a significant change or after recurring problems have been identified.
We can also work on specific qualification, validation, CAPA or governance projects.
The scope may include:
The system connects processes that are often managed separately: deviations, CAPA, changes, complaints, suppliers, training, validation and performance review.
During the assessment, we check how this information is recorded and how a decision in one process affects the others.
The analysis may follow production orders and records, materials, critical steps, reconciliation, in-process controls, cleaning records and other documents related to the batches selected for the sample.
The records of the selected cases must make it possible to reconstruct what happened.
Equipment, systems, environments and processes are included in the scope according to their function and the risk involved.
We assess the available documentation, the current state, changes that have occurred and evidence that the expected performance is maintained.
Records must make it possible to identify what was done, when, by whom and what changes occurred, when this information applies to the system or process.
The analysis may cover paper records and computerized systems, depending on the scope.
A plant producing non-sterile dosage forms does not have the same set of processes as a sterile operation. Biological products, medicinal gases, radiopharmaceuticals and other categories may also require specific controls.
Before starting the work, we define which processes and requirements are included in the scope for the site being analyzed.
An assessment does not need to turn every document in the plant into a single undifferentiated review.
We select samples that allow us to examine real cases: batches, deviations, CAPAs, changes, training or qualifications, for example. The sample can be expanded when a problem indicates that its extent is not yet clear.
When an inspection is scheduled, we organize the work around the time available.
The review helps identify points that require immediate action, documents that need to be accessible and processes that deserve deeper analysis before the visit.
Depending on the scope:
The assessment records the situation found and organizes priorities.
Implementation addresses the controls that need to be created or corrected afterward. The company can contract one stage without necessarily contracting the other.
It depends on the process, the product and the scope required. Before contracting, we check whether Intelilab can carry out the work directly and whether any part requires a specific specialist or partner.
Only if that is part of the scope. Complex sites may need to be divided by process, line or topic.
Yes. Specific projects can be contracted without a full assessment of the plant.