Validation & Compliance

The Compliance team offers specialist quality assurance competences that not only enable them to deliver an “internal quality guarantee service” for our engineering and validation projects, but also to provide our clients with expert support for the typical functions required of their own Quality Assurance and Quality Control organizations and systems. This service is in increasing demand as a result of the relentless pace of today’s technological innovations and constant amendment to the quality and safety requirements by regulatory bodies, which have inevitably led to increasingly rapid changes in the international standards applicable to the pharmaceutical sector. We respond to this need by ensuring that it always keeps pace with the times and is able to provide every client that needs to comply with these changes with a support service that delivers prompt and effective solutions.
img_chi_siamo We offer our clients a full spectrum of services in this area, including:

• Process, cleaning and methods validation
• Validation Documentation Review
• Personnel training
• QA & QC SOP writing
• Internal and Supplier Audits
• GMP reviews
• Rules and guidelines (US & EU) consultancy
• Regulatory Issuess

COMPUTER SYSTEM VALIDATION

We are able to provide the following services in accordance with the current regulations and guidelines for the sector (GAMP, PIC/S Guidance, FDA 21 CFR Part 11, etc.):

img_chi_siamo• Quality system outline
• Policy outline
• Computer system validation
• VMP and VP of computerized systems
• User requirements outline and project documents reviews
• Suppliers audit
• Risk analysis-based approach
• Support to development and testing
• Gap analysis of existing systems and corrective action plans
• Validation and validation report
• Administrative SOPs definition
• Training on rules and guidelines