Computerized System Validation

 

Our computerized system validation services involved computer software for all types of FDA-regulated businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, GLP laboratories, Standalone systems and Cannabis Industries.

 

Cleaning Validation

Our computerized system validation services involved computer software for all types of FDA-regulated businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, GLP laboratories, Standalone systems and Cannabis Industries.

Every project we have completed in recent years was executed in accordance with the strictest standards (GXP) of the European Standardization, FDA and other regulatory agency. 

Our consulting services for computerized system will help customers by adopting a risk-based approach throughout the lifecycle of the quality system taking into account patient safety, data integrity and product quality. Above approach will also support clients on regulatory compliance and the confidence that their overall quality system in place are validated.

We provide full support to the project from start to finish, including writing of protocols, execution and inspection of existing protocols. In addition, we assume responsibility for the project's presentation in regulatory inspections. Our familiarity with the unique requirements of the clean industry guaranties project execution in accordance with the strictest standards of performance quality. 

Consulting services:

Gap Analysis

Data Integrity

Qualification with 21 CFR Part 11 and Annex 11 requirements

Create SOP's and work instructions

Training in the area of CSV

Validation Documents

You are welcome to review some of our projects.