CSV & DATA INTEGRITY

System reliability you can explain.

Building on the risk-based approach of GAMP5*, we make realistic proposals tailored to each client, with nothing missing and nothing excessive. *GAMP: A guideline on CSV published by ISPE (International Society for Pharmaceutical Engineering); the latest edition is GAMP5. GAMP stands for Good Automated Manufacturing Practice.

ISSUE

Find by Challenge

Open the challenge closest to yours to see how we can help.

ChallengeSolution

SERVICE

CSV Support Services

CSV Support Areas Service Areas and Support
  1. 01 / PLANPlanning & Requirements DefinitionPlanning & URS
  2. 02 / DESIGNDesign & BuildDesign & build
  3. 03 / VERIFYVerificationVerification
  4. 04 / OPERATEOperation & ClosureOperation & close
GAMP 5 & SERVICE COVERAGE

GAMP 5 and Our CSV Support Services

3SERVICES

01 / STANDARDGAMP 5A common guide from planning and requirements definition through operation and closure

Related Regulations & GuidelinesMHLW Guideline on Proper Management of Computerized SystemsFDA Part 11PIC/S Annex 11

Main Support

We support building systems that meet regulations and guidelines such as the MHLW Guideline on Proper Management of Computerized Systems, FDA Part11 and PIC/S Annex11.

  • Support for defining CSV policy and preparing computerized system management SOPs
  • Assessing and addressing the CSV status of existing equipment (including spreadsheets)
  • CSV training
  • Guidance on, and implementation support for, systems needed for CSV
  • Creating templates for vendors to provide

A team with deep expertise Our staff are well versed in the latest regulatory trends and have extensive CSV project experience. GMP requirements beyond CSV are also handled through seamless collaboration within our company.

An approach customized for each project We gain a detailed understanding of each project's situation and propose the approach that best fits it.

Track Record

PERFORMANCE

Explore the projects we have supported so far.

All Services

SERVICE

For questions or consultations about our services, please call us or use the contact form.

+81-46-204-5377

Hours: weekdays 9:00–18:00 (JST)

Contact Form Download Materials (Japanese)

Contact

CONTACT

Call usWeekdays 9:00–18:00 JSTContact Us