Services

Qualification & Validation Services

  • Site Master Planning
  • Validation Planning
  • Preparation of User Requirement Specifications (URS)
  • Impact Assessments
  • Risk Assessments
  • Design Review and Qualification
  • Factory & Site Acceptance Testing
  • Commissioning
  • Temperature Mapping
  • Equipment Qualification (IQ / OQ / PQ)
  • Medical Device Qualification (ISO 13485)
  • Computer System Validation
  • Cleaning Validation
  • Process Validation
  • Summary Reporting
  • Revalidations and Periodic Reviews
  • Decommissioning

BSL has experience supplying to large EPCM (V) project delivery specialist companies as well as small niche professional services companies.

Support Services

  • Project Management
  • SOP Development
  • Personnel Training
  • Specific Validation Training
  • Data Integrity Assessments
  • Compliance Gap Analysis
  • FDA / MHRA inspection readiness and audit support
  • FDA / MHRA remediation
Bailey Services

Phone Us+44 (0)7866 483511

Email Usinfo@baileyservicesltd.co.uk

Our Clients:

  • GSK
  • AstraZeneca
  • Teva
  • Novartis
  • IPSEN
  • Porton Biopharma
  • Catapult Cell and Gene Therapy
  • Sanofi
  • Qiagen
  • Novo Nordisk