Quadra 4 Operator Manual
Tomtec
151
11.1.5 Installation
This is covered in the user documentation.
But the steps are:
• Install the Logging software (this will require the .net framework 2.0 (a Microsoft
product). The .net framework is included on the install disk.
• Secure the logging directory.
• Configure the software.
• Start the software.
11.1.6 FDA CFR11 Documentation
This is the FDA CFR11 documentation verbatim from their website:
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
[CITE: 21CFR11]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart A--General Provisions
Sec. 11.1 Scope.
(a) The regulations in this part set forth the criteria under which the agency considers
electronic records, electronic signatures, and handwritten signatures executed to
electronic records to be trustworthy, reliable, and generally equivalent to paper records
and handwritten signatures executed on paper.
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