CSV
Validating a system means ensuring that it meets the applicable GxP requirements and guaranteeing that it is fitness for intended use.
IT GOVERNANCE & COMPLIANCE
In a context of sudden and continuous digital transformation such as the one we are currently experiencing, mastering and properly governing IT processes means being prepared for the continuous technological challenges of our era, in which it is impossible to separate business processes from the IT solutions that support them.
CYBERSECURITY
Cloud services, Industrial IoT, and Robotics are just some of the new technologies that are part of the so-called Digital Revolution of Industry 4.0 and that facilitate innovation and process improvement. However, at the same time, they all expose the organization to new and growing cyber threats, which may represent a blocker to those companies bearing towards progress.
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?
DATA INTEGRITY
The term Data Integrity refers to the accuracy, completeness and consistency of data in its lifecycle and is critical to the design, implementation and use of any computer system in the GxP environment.
COMPLIANCE AS A SERVICE
Our 'Compliance as a Service' model involves the provision of various services in the area of compliance and validation: from the definition and planning of the validation strategy for computerised systems to their maintenance, including support in the preparation and management of regulatory inspections.
PACKAGING COMPLIANCE & VALIDATION
We support the customer in the implementation and validation of packaging and serialisation systems, ensuring regulatory compliance and fulfilment of customer requirements.