Quality Department

An internal team validates the software in accordance with required standards in the food and pharmaceutical industries.

There may be three different professional figures in the sector responsible for different tasks:

Quality Assurance Manager: Organization, maintenance, and monitoring of the company quality management system; In-depth knowledge of current and similar ISO 9001 regulations.

Validation Manager: Organization and supervision of CSV specialists.

Computer System Validation (CSV): Supporting other specialists in preparing technical deliverables and validation protocols.

All these figures have in-depth knowledge on GMP regulations, GAMP guidelines, the concept of data integrity, and regulation CFR 21, part 11 for assessing the compliance of systems using records and/or digital signatures.