Quality and Integrity by Design

QA GUIDANCE AND MONITORING

• Computer system validation projects
• Support for ongoing systems (e.g., system administration guidance, change control, system decommissioning)

 QA AUDITS

• Records (both paper-based and electronic)
• Compliance assessments for qualification of vendors (i.e., suppliers and software development) and test sites
• Process and facility (including analytical and toxicology labs, and IT)
• Site inspections (i.e. regulatory inspection readiness preparation, site qualification)

QUALITY SYSTEM IMPLEMENTATION AND SUPPORT

• Provide training to operational and QA personnel (including regulatory, computer system validation, data integrity, auditing of electronic records)
• Prepare or review standard operating procedures (including computer system validation process, business continuity/disaster recovery policy, and computer system administration)

PROJECT MANAGEMENT

• Preparation and review of computer system validation packages

Services can be conducted remotely or onsite.  Please contact us for additional information.