The Compliance area of CSV Life Science, having specific expertise in quality assurance, as well as providing an internal service of "quality assurance" of engineering design and validation, provides a service to its customers to support the functions of a 'pharmaceutical company: Quality Assurance and Quality Control.

This service is increasingly required in this time in which the continuous technological innovation evolve and the quality and safety aspects inevitably involve an increasingly rapid and progressive change in the international rules relating to the pharmaceutical sector. In this scenario, the business operator must be continuously and constantly updated.

For this CSV Life Science, able to keep up with the times, can provide a support service to all img_chi_siamocustomers who have, in a short time, face these changes. The activities performedfor our clients are:

• 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 Issues.

COMPUTER SYSTEM VALIDATION

By operating in accordance with existing laws and guidelines in the field (GAMP, PIC / S Guidance, FDA 21 CFR Part 11, etc.), CSV Life Science can provide the following services:

• Quality system outline.
• Policy outline.
• Computer system validation.
• VMP and VP of computerized systems.
• User requirements outline and project documents reviews.
• Suppliers audits.
• Risk analysis-based approach.
• Support to development and testing.
• GAP analysis of existing systems and corrective action plans (CAPA plan).
• Validation and validation reports.
• Administrative SOPs definition.
• Training on rules and guidelines.