Services

IMG_1920BW

 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.

cropped-1180x3601.png