Validation of Computerized Systems

Provide documented evidence that computerized systems with GxP impact meet the purpose for which they were designed, ensuring data security, traceability and integrity, product quality, and consumer safety.

We support:

• Structuring of the systems validation department;

• Mapping and drafting user requirements;

• Validation of information systems;

• Validation of automation systems;

• Validation of electronic spreadsheets;

• System and service provider qualification;

• Gap Assessment of GxP software;

• Elaboration of Functional and Technical Specifications;

• Training;

• Allocation of personnel.

Process Validation

Documented evidence attesting that a specific process will consistently produce a product, meeting predefined specifications and quality characteristics, throughout all stages of its life cycle.

We support:

Process validation

Allocation of personnel

  • In the case of new products, the completion of validation must be carried out before their commercialization, as well as new processes and current processes that have undergone impact changes.

Cleaning Validation

Documented evidence proving that cleaning procedures remove residues at predetermined acceptance levels, taking into account factors such as batch size, dosage, toxicological data, solubility, and area of contact of the equipment with the product.

We support:

Cleaning validation

Allocation of personnel

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