When companies usually engage this work
The assessment can be carried out ahead of a scheduled inspection, as part of preventive preparation, or when the company wants to review a specific part of its operation.
It can also be used after relevant changes, such as area expansion, the introduction of new products, supplier changes, system implementation, or a review of the Quality System.
The scope is defined before work begins. A company may need a broad review or only a specific segment, such as transportation, cold chain, CAPA, training, or traceability.
What the assessment can cover
The scope depends on the activity and the problem presented. Topics that can be assessed include:
- Licenses and regulatory classification of the operation
- Procedures and records
- Training and responsibilities
- Deviations, CAPA, and change control
- Suppliers and service providers
- Receiving, storage, and shipping
- Transportation and routes
- Cold chain
- Returns and recall
- Traceability
- Computerized systems
- Facilities, equipment, and environmental controls
Items unrelated to the operation are not included just to lengthen the checklist.
How the assessment is carried out
- We start by defining the site, processes, and period to be analyzed.
- Next, we request the documents and records needed for the scope. The sample is selected to allow review of real cases, such as deviations, CAPAs, changes, training, or transportation incidents.
- Interviews are used to understand responsibilities and how activities are carried out. When there is a site visit, we follow the flows included in the work and record the relevant observations.
- The report is prepared after this information is cross-checked.
What we use as evidence
A conclusion may rely on different sources: a procedure, a completed form, an electronic record, an interview, an authorized photograph, a system report, or an observation made during the visit.
The source is linked to the finding. If the available material does not support a conclusion, the point is kept as not verified.
How findings are classified
The classification considers the relevance of the issue and the need for action.
A finding may require immediate containment, priority correction, or scheduled action. Improvement points are kept separate from nonconformities when they do not represent the same situation.
The aim is to avoid a report in which dozens of items carry the same weight.
What the company receives
The exact content depends on the contracted scope. An assessment may include:
- Executive summary
- List of processes analyzed
- Findings and corresponding evidence
- Criticality and priority
- Items not verified
- Recommended containment actions, when needed
- Action plan
- Criteria for closure and effectiveness verification
What the assessment does not do
The assessment does not certify compliance and does not guarantee the outcome of a future inspection.
Nor does it replace the decision of the Brazilian health authority. The report records what was examined within the contracted scope and the conclusions supported by the available evidence.
Preventive assessment and scheduled inspection
When no inspection is expected, the work can be planned with more flexibility and used to build a correction schedule.
When the inspection already has a date, the available time changes how priorities are set. We first identify the points that require immediate attention and what can be demonstrated with existing records. Changes that need longer implementation remain recorded in the action plan.
The assessment may lead to other work
After the analysis, the company may need to revise procedures, structure CAPA, implement controls, validate a system, qualify a route, or create a governance routine.
This work is defined separately. The assessment does not presuppose engaging the next stage.
Operations served
The assessment can be applied to manufacturers, importers, distributors, storage providers, and carriers of medicines and medical devices, in line with the scope and requirements applicable to each operation.
It can also be used by companies that are structuring or reviewing their Quality System.
Frequently asked questions
Is an on-site visit required?
It depends on the scope. Some work can begin with document review and remote interviews. When the conclusion depends on observing the operation, the visit is included in the planning.
Do you review all of the company's documents?
Not necessarily. The selection is made according to the scope and the sampling defined for the assessment.
Can Intelilab help correct the findings afterward?
Yes, when that support makes sense. Implementation or review of the controls is contracted separately from the assessment.
Does the report guarantee approval in an inspection?
No. The inspection is conducted by the competent authority and may include facts, documents, or situations outside the scope analyzed.
Need to review your operation?
Tell us what is happening and how much time you have. From there, we define the scope needed for the assessment.