Services
- Update or draft a Site Master File
- Define Validation Strategy/ Validation Concept
- Write/review Validation Plan/Master Plan
- Review of Qualification and Validation Documentation
- Draft Cross Contamination Quality Risk Assessment, - Plan _ follow up / closure report
- Write Project Description _ Cannabis Growth and Handling (Development scheme)
- Support to Microbial challenges in Cannabis production
- Perform GMP review of Cannabis production facilities
- Set up of Pharmaceutical or Cannabis Quality Systems
- Draft Control Strategy - based on risk assessments
- Due Diligence of Quality Compliance of companies in connection with mergers and acquisitions
- GMP compliance review of GMP projects and/or buildings - greenfield or brownfield re-construction project
- Cold Chain transportation support & GMP/ GDP audits
- Supplier audits /Lean & Optimization of Supplier set-up (risk based)
- Product Quality Reviews/Annual Product Reviews
- Combination Products (drug - device)
- Interrim staff substitute for employee or manager
- Overall compliance support - i.e:
- Audit/ Inspection preparation,
- GMP training - basic or annual update,
- SOP writing protocols, reports,
- Supplier Agreements etc. & Quality Agreements
Ways2Compliance ApS
CVR no. 40946063
