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

Overview

Our knowledge of IT system validation compliance with respect to UK, European and International regulatory guidelines (MHRA, EMEA, FDA & ISO) is the result of more than 18 years CSV involvement within the pharmaceutical, biotech and medical device industries.

Our aim is to help our clients handle the complex rules and guidelines that these highly regulated industries are subjected to and acting as the customer's guarantee that the necessary cGMP rules, guidelines and latest regulatory trends are observed.  In this way 'regulatory challenges become compliance successes', with regards to:

  • cGxP
  • FDA 21 CFR Part 11, Part 820 & 860
  • Annex 11
  • GAMP 5
  • SDLC
  • ICH Q8, Q9 & Q10
  • Sarbanes-Oxley (SOX)
  • ISO 13485:2003 & ISO 14971
  • QSIT
  • ISO 9001:2000 & QS9000

Consultants hold registered chartered status within their chosen field and are also experienced project managers.  All projects are managed to successfully meet goals for scope, timelines, quality and cost and so incorporating the requirements of the client.

 

Computer System Validation (CSV) and Data Integrity (DI) Compliance

  • System data integrity (ALCOA+)/gap analysis

  • Sterile manufacturing (cleanroom)

  • Aseptic liquid filling

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

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

  • Eudralex Volume 4, Annex 1, 11 & 15

  • ISO 13485, 14971, 9001

  • Sarbanes-Oxley (SOX)

  • High-speed packing lines

  • Laboratory automation/robotics/analytical systems

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

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

  • System qualification (IQ, OQ, PQ) protocol

  • Machine virtualisation/data archiving

  • Electronic data migration & virtualisation

  • System retirement

  • Business continuity/disaster recovery planning

  • CSV/CSQ documentation suite compilation

Audit Related

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

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

  • Eudralex Volume 4, Annex 1, 11 & 15

  • ISO 13485, 14971, 9001

  • Sarbanes-Oxley (SOX)

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