CSV Consulting Service

Service overview

EP Croit has a long record of providing computerized system validation (CSV) plans based on system size and risks. From system implementation to operation and retirement, we offer support for your system life cycle needs.

*CSV: Computerized system validation, SOP: Standard operating procedure
ER: Electronic record, ES: Electronic signature
QC: Quality control, QA: Quality assurance

Compliance to guidelines

We support you from SOP development through assessment, tailored to your circumstances and requirements and comply with changes implemented by the following guidelines.

 

  • GxP regulations
  • ER/ES policies
  • Guideline on management of computerized systems
  • GAMP
  • 21 CFR Part 11

*GAMP: Good Automated Manufacturing Practice

Project management by our experienced consultants

  • We have experience in CSV support for numerous different types of package systems, not limited to our own.
  • We utilize our experience from various contracted GxP operations and pharmaceutical companies to provide detailed suggestions for business processes.
  • We also have excellent project management skills, acting as a liaison between users and vendors.
  • We offer lectures and periodic consulting services on GxP operations by staff with previous operational experiences at pharmaceutical companies.

Experiences

We have worked with 300 cases across 30 companies in clinical, regulatory, and pharmacovigilance areas, as well as academia.

Examples of our support

  • Electronic data capture (EDC) validation
  • Document management system validation
  • CDISC system validation
  • Assessment for overall clinical development process
  • Development of ER/ES and CSV policy and regulation
  • Vendor audit
  • Electronic common technical document (eCTD) system validation
  • Electronic submission system assessment
  • Assessment for overall regulatory submission process and systems
  • Pharmacovigilance (PV) system validation
  • Electronic Data Interchange (EDI) system validation
  • Assessment for PV system
  • Assessment for overall PV operations
  • Clinical research process and system audit

Optional services we offer

Model documents

  • Our CSV SOP model documents are compliant across various guidelines.

Seminars

  • We hold onsite seminars to explain our consultants’ guidelines.

Expert advice

  • Our consultants will answer any questions you may have.

 


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