From people who have shared more than two decades of industry experience, and who have experienced the birth and evolution of the Computer System Validation, we have created the current approach of the IT COMPLIANCE Product Line .
IT Compliance Product Line provides consultancy for IT and QA, in order to ensure regulatory compliance and a quality system for the IT Department that meets the needs for flexibility of constantly changing technologies, providing at the same time services for meeting the regulatory requirements.
CTP SYSTEM services:
- Support for the management of a computer system life cycle in GxP context
- Computer System Validation with documentation preparation both for client and vendor
- Information systems
- Automation systems
- Data acquisition and processing systems
- Assessment of the systems compliance with respect to the binding regulations
- Remediation Activities for computer systems - Action Plan following Assessment/Audit
- Support for Business/GxP Analysis of processes for choice of IT solutions
- Software/Supplier Selection
- Audits to systems suppliers
- IT infrastructure qualification
- Provision of quality integrated IT systems (GxP, ISO 9001, ISO 20000, ISO 27000, etc.)
- Risk assessment
- Practical solutions for GxP reports
April 2015 - newspaper NCF (Notiziario Chimico Farmaceuitico):
Mobile Medical Applications. Regulated Mobile Apps management.
Considerations on critical issues related to the implementation of regulated mobile applications: the new GAMP Good Practice Guide "A Risk-Based Approach to Regulated Mobile Applications"
For technical information:
Anna Lidia Vignoli
Mob. +39 348 5253953