Validation and Qualification | Ensure Regulatory Compliance

Ensure Compliance and Reliability

of your systems and equipment

In the pharmaceutical, biotechnology, and medical device industries, validation and qualification of systems, equipment, and IT infrastructure are essential to ensure safety, quality, and regulatory compliance.

At Ambit Iberia, we offer specialised solutions to ensure your technological processes meet the highest standards, such as GMP, FDA 21 CFR Part 11, and GAMP 5.

PRODUCTS

ManVa
SaaS System Validation

ManVa is our specialised solution for validating SaaS systems, ensuring that cloud-based software meets regulatory requirements in the Life Sciences sector.

With ManVa you can:

Automate the validation process for cloud-based software.
Ensure regulatory compliance with standards such as GAMP 5 and FDA 21 CFR Part 11.
Reduce costs and time in audits and regulatory reviews.

Digital Validation
Digital System Validation

Digital Validation (DV) is our comprehensive solution for digital validation, designed to optimise and automate the management of the validation lifecycle.

Benefits of Digital Validation:

Centralisation of all validation documentation in a secure digital environment.
Reduced errors and greater traceability in the validation process.
Speed and efficiency in validating IT and technological systems.