Project Experience

Some recent examples of successful projects delivered by the Rx GLOBAL Team:

Validation Planning

  • Preparation of Site VMP for Sterile Drug Manufacturer
  • Preparation of CSV VMP for Biotechnology Sterile Drug Manufacturer
  • Preparation of multiple ERP System Validation Plans including Cannibus Manufacturing site experience

Regulatory Compliance Assessments & Auditing

  • cGMP compliance audits of API, contract manufacturing and distribution facilities to Health Canada, FDA and EU regulatory standards
  • CSV Data Integrity assessments
  • Digital Asset Security Risk Assessments

Computer System Validation

Rx GLOBAL has executed hundreds of CSV projects on a local and global basis across the enterprise. The team specializes in complex, multi site implementations involving ERP, WMS, QMS, DMS and MES

Data Integrity 21 CFR Part 11

Performed full site assessments of all computer systems 21 CFR Part 11 compliance and Data Integrity assurance for multiple clients

Preparation and execution of site remediation plans for identified compliance gaps

Project Management

Project Management of global ERP system implementations

Management of IS/IT infrastructure upgrades, enterprise system deployments and Service Desk improvement projects

Commissioning and Qualification

Creation, review, execution and summary of commissioning and qualification documentation for bottle, bag in box and pouch liquid filling and packaging lines. C & Q of multiple mix tanks, hold tanks and supply lines including associated automation control programs and equipment

Cleaning Validation

Assessment and generation of cleaning evaluation/equivalency reports for liquid filling process equipment.

Technical Writing

Review and revision of SOPs for multiple operational units across multiple plant sites. Provided document standardization and process efficiencies for large drug manufacturing and laboratory operation.

Process Validation

Creation, review, execution and summary of process validation documentation for bottle, bag in box and pouch liquid filling and packaging lines.