Intelilab helps companies operating in Brazil, under Anvisa rules, identify gaps, organize controls and prepare for inspections based on the analysis of documents, records, processes and the company's day-to-day operations.
Intelilab works with companies of different sizes, focusing on regulatory quality and operations subject to Brazilian health surveillance authorities.
We work with manufacturers, importers, distributors, storage providers and carriers of medicines and medical devices. We also work with companies that are setting up or reviewing their Quality System.
The company may be preparing for an inspection or a license renewal. It may have received an infraction notice. It may be reviewing carriers, cold chain, storage or traceability.
In other cases, the need arises within the Quality System itself. There are recurring deviations, CAPAs that remain open, outdated procedures, training that needs to be reviewed or suppliers that have not yet gone through an adequate evaluation.
We also work with companies that are setting up these controls for the first time.
Defining the work starts with the problem the company needs to solve.
The assessment starts with defining the scope. From there, we select the documents, records and processes that need to be examined.
Depending on the work, we may analyze licenses, procedures, training records, deviations, CAPAs, changes, suppliers, storage controls, transportation, systems and other documents related to the activity.
Interviews and site visits are included when they are part of the scope.
The problems found are recorded with the corresponding evidence. We then assess their criticality, the treatment priority and the actions that need to be followed up.
Learn about assessment and inspection readinessWe analyze the operation ahead of an inspection or as a preventive review.
The work identifies the points that need correction, records the evidence found and organizes the actions by criticality and priority.
Learn about the serviceWe can build a Quality System from the ground up or review the one the company already uses.
The scope may include procedures, records, deviations, CAPA, changes, training, suppliers, self-inspection and the controls needed to monitor these activities.
Learn about the serviceThe work is defined according to what needs to be qualified or validated.
We can work on computerized systems, equipment, environments, transportation and cold chain, within the scope defined for each project.
Learn about the serviceGovernance organizes the periodic review of Quality System information.
Indicators, deviations, CAPAs, changes and other relevant records are brought together so management can track open items, recurrences and decisions made over the period.
Learn about the serviceWhen a company receives an infraction notice, we analyze each item separately and gather the documents, records and facts related to the case.
Based on this material, we structure the technical analysis and the actions related to the causes identified. Legal matters remain outside this technical scope.
Learn about the serviceIntelilab uses its own Artificial Intelligence tools for tasks that currently take up hours of the quality team's time. AI prepares the material. Analysis and approval remain with qualified people.
In distribution and storage, the work may involve receiving, storage conditions, environmental monitoring, inventory, segregation, shipping, returns, recall, traceability and supplier control.
Distribution and storageIn transportation, we assess controls related to carriers, routes, vehicles, transport conditions, monitoring, incidents, records and cold chain, when applicable.
TransportationFor manufacturers, the scope may include the Pharmaceutical Quality System, production, controls, batch records, deviations, changes, qualification, validation and computerized systems.
The items assessed depend on the manufacturing process and the product involved.
Manufacturers / GMPFor medical devices, the scope also depends on the company's activity.
A manufacturing site, a distributor and a company that only stores products require different scopes of analysis.
Medical devicesThe work starts by classifying the company and defining what will be analyzed.
If the scope includes deviations, for example, we check the procedure and open actual records to understand how the cases were investigated and closed.
The same reasoning applies to training, suppliers, storage, transportation and other processes.
That is why an analysis may combine documents, records, interviews, system data and observations made during the site visit.
Each source helps answer one part of the same question.
A procedure may state that every deviation undergoes a root cause investigation.
When we open the records, however, we may find cases closed with only an immediate correction.
A training procedure may be up to date, while the records show people performing an activity without the required training.
In storage, the procedure may define limits and responsibilities for temperature monitoring. The records show whether this was done and how the company handled any temperature excursion.
This comparison is what shows whether the control described in the document also appears in the records and in practice.
Not all problems found are at the same level.
One finding may require immediate containment. Another may need correction within a defined deadline. There are also points that can be addressed as part of a planned improvement.
We record this sequence so the company can track the treatment:
Closure also requires evidence. Changing the status to completed does not, on its own, demonstrate that the action was implemented.
The deliverable varies according to the work contracted. In an assessment, we may present:
The company receives a record of what was analyzed and a basis for tracking corrections after the assessment.
If you have a scheduled inspection, an infraction notice or another specific need, talk directly to Intelilab.