The FDA (Food and Drug Administration) as U.S. Food and Drug Administration
is a very influential administration even internationally. In 1997, to face the increase of data exchanged, FDA established the 21 CFR Part 11 standard that applies to all pharmaceutical, cosmetic and food industries wishing to market their products in the United States or internationally. All the regulatory provisions that the organization must comply with in terms of keeping electronic records and signatures in order to guarantee the reliability and integrity of data are set by the standard.
Our “Integrity Manager” software is used in conjunction with our image analysis software to enable you to work within these guidelines.This software protects the data of the executed application and limits the actions that can be performed by the operators according to their role in the organization. The general manager (lead role with all rights), defines the different roles and rights according to its own methodology. The audit trail is accessible and exportable and lists all the data and events generated by the application up to their source.
Integrity Manager is an optional module that must be provided and installed in addition to Microvision Instruments analysis software programs to enable you to work in compliance with 21 CFR Part 11
- Data protection
- Limitation of actions that can be carried out by operators depending on their role in the organization
- Complete audit trail of actions and changes made during the analyses
- FDA 21CFR Part 11 Compliance
- Data Integrity Compatible
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