PMDA · Life Science & Pharma: GxP - CSV & Data Integrity
Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs (Japan)
Final CSV · Guideline Last verified: not yet · Source last checked 3 Nov 2026
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Japan's guideline on computerised systems for drug manufacturers, covering a system's life from development to retirement.
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- The line under the title explains in plain words what this item is for. The coloured label beside its status gives its Category, its main subject, and Sub Category, the type of document, in the same colours as the maps.
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- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
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Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Notification No. 1021-11 issued
In plain English
Japanese guideline on managing computerised systems, issued by the health ministry (MHLW) as Notification No. 1021-11 and hosted by PMDA. The English is a tentative translation that MHLW has not formally authorised, and the Japanese text prevails. Link only.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
This Japanese guideline was issued as a Notification by the Ministry of Health, Labour and Welfare (MHLW) on 21 October 2010, and PMDA hosts it. It revises a 1992 guideline. The English is a tentative translation that is not formally authorised, and the Japanese text prevails.
Who and what it applies to
Marketing authorisation holders and manufacturers of drugs and quasi-drugs using computerised systems under Japan's GQP and GMP ordinances. Examples of covered systems are listed, and Appendix 2 lists those out of scope.
What it contains
- General principles and scope
- Purpose and what is covered.
- Development documentation and operations
- Documents and development.
- Validation activities
- Validation work.
- Operations management
- Running the system.
- Internal audit, retirement, records
- Audit, system retirement and document management.
- Terminology and appendices
- Definitions and tables, including system categories.
Key points
- It uses a lifecycle approach, from development to retirement.
- It is an MHLW notification, hosted by PMDA.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- If you serve Japan, compare it with Annex 11.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 21 Oct 2010 | Notification No. 1021-11 issued | Final | Source for Notification No. 1021-11 issued |
Official source
The official text always prevails over anything on this site.
Summary in our own words. See the official text from PMDA.
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