Vineplus Limited Validation Services (IT)
Vineplus LimitedValidation Services (IT)

Background

Computer System Validation (CSV), Computer Software Assurance (CSA) & Data Integrity (DI) Compliance

  • Data integrity (ALCOA++)

  • Sterile manufacturing (cleanroom)

  • Aseptic liquid filling

  • High-speed packing lines

  • Laboratory automation/robotics/analytical systems

  • Clinical EDC, IRMS (cloud-based)

  • Safety Data Systems

  • Facilities monitoring/access control/SCADA/MES/ERP/Hisorian

  • GAMP 5, cGxP, SDLC, gap analysis, risk assessment & remediation planning

  • System qualification (IQ, OQ, PQ) protocols

  • Machine virtualisation/data archiving

  • Electronic data migration

  • System retirement

  • Business continuity/disaster recovery planning

  • CSV/CSA/CSQ documentation suite compilation

 

Audit Related

  • Internal audit/supplier audit/pre-regulatory/expert witness

  • Data integrity gap analysis

  • FDA 21 CFR Part 11, 210, 211, 820 & 860

  • Eudralex Volume 4, Annex 1, 11 & 15

  • ISO 13485, 14971, 9001

  • Sarbanes-Oxley (SOX)

  • ICH E6, Q8, Q9 & Q10

 

Approach

The CSV/CSA approach (GAMP 5/SDLC) places emphasis on system deployments in highly regulated (FDA/MHRA/Eudralex) GxP environments, utilizing the current risk based approach with regards to data integrity, system security, access control, configuration management and audit trail requirements, ensuring regulated compliance and that ‘the validated system performs as designed and intended.’

 

CSV/CSA Activities

Completion of Risk Assessments (FMEA, 5 Whys, Fault Tree Analysis) to:

  • Define system installation and operational requirements

  • Verify business impact

  • Ensure a cost-effective validation effort

Ensure Compliance of Regulatory Requirements (FDA/MHRA/Eudralex) relating to code of Federal Regulation, CFR Title 21:

  • Part 11, Electronic Records/Electronic Signatures

  • Part 210, cGMP in Manufacturing, Processing & Packaging

  • Part 211, cGMP for Finished Pharmaceuticals

  • Part 820, Quality System Regulation

  • Part 860, Medical Device Classification

Eudralex Volume 4:

  • Annex 1, Manufacture of Sterile Medicinal Products

  • Annex 11, Computerised Systems

  • Annex 15, Qualification and Validation

 

 

 

Experience

Extensive CSV/CSA project management deployment experience related to the pharmaceutical, biotech and medical device industries, including stakeholder technical team and vendor management.

Project management experience of leading and supporting CSV/CSA business critical (high value) UK, European & International based projects.

This has included complete project (milestone driven) and systems development life cycle (SDLC), from design to system deployment.

 

Manufacturing & Facility Project Deployments

  • Environmental monitoring systems (EMS)
  • Manufacturing execution systems (MES)
  • High speed filling and packing (aseptic liquid)
  • Electronic batch records
  • Historian systems
  • System virtualization/data integrity archiving
  • RFID warehousing
  • Access & control systems
  • Time & attendance systems
  • Enterprise systems
  • Global chromatography data systems
  • Laboratory information management systems (LIMS)

  • Electronic laboratory notebooks

  • Analytical laboratory systems (standalone & networked)


Sales & Marketing

  • Product marketing applications (Tablet/PC)

 

 

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