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Part 11 Compliance Using File
Replication and Mirroring System (FRMS)
21 CFR Part 11 has
enacted several mandates to ensure the
security, integrity and authenticity of
electronic records and signatures. The
law outlines controls for ensuring that
electronic records and e-signatures are
trustworthy, reliable, and compatible with FDA
procedures. The ultimate goal: Make electronic
records and e-signatures as verifiable and
traceable as their paper counterparts.
Part 11 is not specific to any type of
technology or instrument type, but applies to
all instruments, all applications, and all
operations that generate data electronically
to durable media. Therefore, when a
change is made to a record, the system must
save the old version — not overwrite
information — as well as keep track of the
date, time, data acquisition system
identifier, and user ID of the person that
made the change. In other words, an auditable
version of each change must be available to
ensure data integrity and authenticity.
In addition, a critical
aspect of Parts 11 and 58 is Data
Protection, requiring compliant backup
methodologies to ensure the security,
integrity and authenticity of all electronic
records. Along with ensuring data
integrity, building the facilities and
processes to recover from a system crash are
also central to compliance. In the event of a
disaster, crucial development data must be
recoverable and uncorrupted. Procedures need
to be created for regular backups, with
processes periodically checked so that data,
when recovered, are correct.
FRMS provides a
transparent but highly effective shield
against data losses due to data acquisition
system crashes, inadvertent data overwrite,
with an embedded versioning build-in feature
giving your business an unprecedented coverage
against any kind of data losses.
FRMS Server: Real time replicated data are stored in a RAID-5 storage
repository, with dynamic disk partitions patterned
after individual instrument data acquisition
system drive, enabling exact 1:1 data characteristics.
FRMS
Client:
All data acquired are monitored and
replicated via a secure TCP/IP based
protocol to FRMS server
FRMS NAS/SAN
Backup: A network attached storage (NAS) or storage area network
(SAN) based disk array provides a RAID 0 + 5
backups (incremental and full) based on your
business needs.
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