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FDA/EPA Compliance Certificates
Click on the appropriate instrument link below to access FDA’s 21 CFR Part 11 and EPA Compliance Certificates. Shimadzu has received a “strong affirmative” from third party consultant, Dr. Sandy Weinberg of the Biomedical Regulatory Institute, with respect to instrumentation/software tools available to meet these regulatory requirements. The certificates are made available for the customer convenience and to address any regulatory or audit issues that may arise.
Click here for related information from the FDA website.
Click here to read Shimadzu's Compliance/Global Support Information.
- All FDA listed products (PDF/383KB)
- All EPA listed products (PDF/371KB)
AA
- WizAArd version 4 (FDA) (PDF/358KB)
- WizAArd version 4 with Class-Agent version 2 (FDA) (PDF/353KB)
- WizAArd version 4 (EPA) (PDF/325KB)
- WizAArd version 4 with Class-Agent version 2 (EPA) (PDF/336KB)
Balances
- Class-Balance Agent version 2 (FDA) (PDF/342KB)
- Class-Balance Agent version 2 (EPA) (PDF/334KB)
GC
- GCsolution version 2 (FDA) (PDF/354KB)
- GCsolution version 2 with Class-Agent version 2 (FDA) (PDF/350KB)
- GCsolution version 2 (EPA) (PDF318/KB)
- GCsolution version 2 with Class-Agent version 2 (EPA) (PDF/328KB)
GCMS
- GCMSsolution version 2 (FDA) (PDF/349KB)
- GCMSsolution version 2 with Class-Agent version 2 (FDA) (PDF/358KB)
- GCMSsolution version 2 (EPA) (PDF/325KB)
- GCMSsolution version 2 with Class-Agent version 2 (EPA) (PDF/336KB)
HPLC
- LCSolution version 1 (FDA) (PDF/344KB)
- LCSolution version 1 with Class-Agent version 2 (FDA) (PDF/350KB)
- LCSolution version 1 (EPA) (PDF/316KB)
- LCSolution version 1 with Class-Agent version 2 (EPA) (PDF/328KB)
LCMS
- LCMSSolution version 3 (FDA) (PDF/353KB)
- LCMSSolution version 3 with Class-Agent version 2 (FDA) (PDF/361KB)
- LCMSsolution version 3 (EPA) (PDF/326KB)
- LCMSSolution version 3 with Class-Agent version 2 (EpA) (PDF/332KB)
TOC
- TOC-Control V version 1 (FDA) (PDF/363KB)
- TOC-Control V version 1 with Class-Agent version 2 (FDA) (PDF/360KB)
- TOC-Control V version 1 (EPA) (PDF/328KB)
- TOC-Control V version 1 with Class-Agent version 2 (EPA) (PDF/338KB)
Spectro
- IRSolution version 1 (FDA) (PDF/360KB)
- IRSolution version 1 with Class-Agent version2 (FDA) (PDF/365KB)
- IRSolution version 1 (EPA) (PDF/336KB)
- IRSolution version 1 with Class-Agent version2 (EPA) (PDF/336KB)
- UVProbe version 2 (FDA) (PDF/363KB)
- UVProbe version 2 with Class-Agent version 2 (FDA) (PDF/370KB)
- UVProbe version 2 (EPA) (PDF/325KB)
- UVProbe version 2 with Class-Agent version 2 (EPA) (PDF/334KB)