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MAX Solutions are
Designed to Support the Requirements of FDA 21 CFR Part 11
Compliance with the FDA
requirements of 21 CFR
Part 11 requires a
combination of enabling
software and the proper
operations.
MAX offers a number of
enabling features in our
solutions that are the
first step towards
compliance. Our
software solutions, in
combination with the
proper procedures,
training and
configuration, allow our
customers to
implement solutions that
to meet the requirements
of 21 CFR Part 11.
MAX solutions include
the following enabling
features:
- Complete change control management and audit trails of all additions,
changes, and inactivation
of:
- Configuration Data
- Operational
Data
- Data cannot be
deleted, only inactivated
- Secure central storage of all configuration and operational
data
- Unique access to screens based on
user class (User, Super User,
Administrator)
- Individual user access can be limited by
area, job
type and training
credentials
- Extensive tracking all
successful and
unsuccessful usage
events, the events include logons and
screens opened
- Setup electronic
signatures based on
the operation
performed and data
changed
- Configure the
number of electronic
signatures required
and the credentials
that the person must
have to sign-off
Bar code Tools for 21 CFR Part 11 Compliance
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