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Some recent examples of successful projects delivered by the Rx GLOBAL Team:
Validation Planning
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
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
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
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
Project Management of global ERP system implementations
Management of IS/IT infrastructure upgrades, enterprise system deployments and Service Desk improvement projects
Commissioning and Qualification
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
Cleaning Validation
Assessment and generation of cleaning evaluation/equivalency reports for liquid filling process equipment.
Technical Writing
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
Process Validation
Creation, review, execution and summary of process validation documentation for bottle, bag in box and pouch liquid filling and packaging lines.
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