QStep

Computerized System Validation,
Data Integrity,
IT Governance & Compliance,
Compliance as a Service
Packaging
Cybersecurity

The right choice for every need of Computerized System Validation, Data Integrity, IT Governance & Compliance in a GxP environment

A team of professionals with interdisciplinary skills able to work in a flexible and organised manner to meet customer needs. We have consolidated experience in projects for the implementation and validation of IT solutions, both locally and internationally, to support pharmaceutical processes: from the pleclinical phase, through clinical trials to the production and commercialisation of drugs.

We support the customer in the implementation and validation of packaging and serialisation systems, ensuring regulatory compliance and fulfilment of customer requirements.

WHAT WE ARE DOING

We use proven, agile tools and methods in the delivery of services to ensure that our clients achieve their compliance goals.

Ensuring the validation of computerised systems in life science is a legal and quality requirement.

COMPUTERIZED
SYSTEM VALIDATION

Data is a strategic asset in the life science world. We help you ensure their integrity as an essential element in understanding processes and making informed decisions.

DATA INTEGRITY

COMPLIANCE AS A SERVICE

IT GOVERNANCE & COMPLIANCE

The continuous evolution of life science technology requires governance of IT processes to ensure compliance with international standards (e.g. ITIL, Cobit, GAMP).

We help companies contain costs and reduce risks at every stage of a computerised system's life cycle by putting our team of experts at their disposal to manage and maintain its validated status.

ABOUT US

QSTEP at a Glance

HOW WE DO IT

We provide strategic GxP consulting services to our clients: from small start-ups to large multinationals and software providers in the life sciences sector.
We help our clients in the selection and qualification of IT suppliers. We develop training projects on CSV, IS and IT Security topics tailored to the customer's needs.
We support both large and small/medium-sized companies in the preparation and management of regulatory inspections (e.g. FDA, AIFA, ANVISA, MHARA).

PACKAGING COMPLIANCE &VALIDATION

CYBERSECURITY

Cyber-attacks can impact or stop the production operations, even for long periods, or put people's safety at risk if threats are not addressed appropriately. The Life Science Sector is no exception. Are you willing to take this risk?

QSTEP is for you if…

OUR CLIENTS

QSTEP