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InfoPV 10i is a comprehensive software solution for managing both process validations and test method
validations in accordance with the FDA's 21 CFR Part 820.75 regulation and ISO 13485 standard.
MVP
Process Output 1
InfoPV 10i allows creating and maintaining all essential Input 1 Step 1
Sp oces
? Operation Qualification (OQ – challenge conditions) ec s
s
PPQ
MVR
InfoPV:
Is fully validated
?
Has comprehensive security features
?
Includes elaborate audit trail functionality
?
Is compliant with 21 CFR Part 11 eRecords and eSignatures
?
regulation
Allows attachment of external documents to PV and TMV
?
88 Stiles Road
Salem, NH 03079 USA
tel: 603-890-3311
fax: 603-890-3322
email: info@makromed.com
web: www.makromed.com