Systems Validation & Compliance

 

Informed by industry best practices such as Human and Health Services (HHS), Good Automated Manufacturing Practice (GAMP), National Institute of Standards and Technology (NIST), Essex utilizes a highly structured and metrics based approach to validation.  Our tools include:

 

• Essex Tailoring Questionnaire, to confirm the business and validation scope, regulatory compliance determination level, deliverables output and estimated work effort .

• Assessment checklist

• Assessment Report, with overview of findings, conclusion, risks, remediation strategies, and plans.