Insights:

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.







Insights:
Insights: