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MiraCal/DataX Solution to 21 CFR Part 11 Regulation
21 CFR Part 11 is a regulation enforced by the FDA on the
conditions under which electronic records and electronic signatures will be
accepted in lieu of paper records. Title '21' covers GCP, GLP and GMP for
"Food and Drugs" (Pharmaceutical, Food, Blood Products, Medical Devices, etc.),
'CFR' is the code of federal regulations, and 'part
11' is regulating issues relating to electronic records and electronic
signatures. MiraCal satisfies all these requirements and therefore enables 21CFR part 11 compliance.
The four main purposes of the regulation and METTLER TOLEDO's
solutions are outlined below.
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1.
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To allow for the use of electronic records and signatures instead of having
to store and submit paper records.
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METTLER TOLEDO Solution
We understand that this is not only an evolving FDA requirement but also a
general customer request. Today companies choose to go the more convenient
paperless way under the condition of having 24/7 access to documentation. To
satisfy this requirement, METTLER TOLEDO has heavily invested to take MiraCal
one step further and make certificate and other asset management data available
to customers through DataX. To give customers access to calibration data via
server is a unique approach in the industry.
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2.
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To prevent, or at least reduce the risk of, records being deliberately
manipulated or falsified.
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METTLER TOLEDO Solution
All calibration data is stored as electronic records in a secure database. No
user interface exists to alter the data during certificate creation or after
the data has been stored, neither on the technician’s laptop nor on the central
server. The user interface has been designed in such a way that changing any
data that has been entered and saved is not possible. In addition, the software
has been subject to validation procedures to ensure that it functions correctly
in this manner.
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3.
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To prevent unauthorized access to data.
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METTLER TOLEDO Solution
The database that stores the calibration records is password-protected and
located on a protected server inside the METTLER TOLEDO firewall. Within
METTLER TOLEDO, only the head of the calibration laboratory and the metrologist
have access to the database.
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4.
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To ensure traceability to the originator or owner of data.
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METTLER TOLEDO Solution
Each calibration document has a unique identification number that is traceable
to the technician who generated the data. The first time a calibration document
is accessed, the unique identification number gets the ending "-E0001". "E"
stands for "Electronic version" and the number automatically is increased by
one increment each time this document is accessed.
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