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 of a pharmaceutical company: Quality Assurance and Quality Control. This service is more and more requested due to the continuous evolution of technological innovations and the constant amendments to quality and safety requirements made by regulatory bodies which inevitably lead to an increasingly rapid and progressive change in international standards for the pharmaceutical sector.

We respond to this need, since we are able to keep up with the times and provide a support to all clients who have to deal with these changes in a short space of time by providing effective solutions.

img_chi_siamoWe 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


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.):

• 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