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Home - Analytical Instruments - Software - 21 CFR Part 11 |
Is
your Software 21 CFR part 11 Compliant?
21 CFR part 11 is the FDA's ruling on electronic records and
electronic signatures. It affects regulated industries,
particularly companies that wish to switch from paper-based
records to computer-based electronic records. For example,
pharmaceutical manufacturers that want to use electronic records,
documents, and submissions must comply with 21 CFR part11.
Companies within these regulated industries rank among the top
users of analytical instrumentation. They will buy instrument
systems and software from vendors that can help them comply with
21 CFR part11 regulations.
ELICO ltd has experience in providing 21 CFR Part 11 Compliance to
Data Acquisition Analysis software for analytical instruments and
offers to provide compliance in EXISTING or NEW software
applications of its clientele.
ELICO ltd is an ISO 9001 Technology Services company founded in
1960. The Technology services division designs and develops
Analytical Instruments and offers high-end solutions in the field
of analytical instruments, embedded systems and application
software development.
Salient Features that will be provided include
- System Logins and Passwords.
- Access Control and User Privileges.
- Auto Detection of Data Tampering.
- Comprehensive Audit Log.
- Electronic Signature Records.
System Logins and Passwords
The Software developed or customized will utilize the NT Security
model provided by Windows NT/2000/XP. Users are identified by
their windows login name and password eliminating the need for
maintaining a separate user name and password list.
Access Control and User Privileges
Software will support network installations for centralized
user management. The administrative tools provided will permit you
to set the Access Privileges of each user or a group of users.
Auto Detection and Data Tampering
Every time you store the data, An integrity value is
calculated which is stored with in the file, This value is an
encrypted representation of file content and serves as a unique
fingerprint for the data. When you reopen the file the integrity
value is recalculated and verified. Software alerts the user when
data is corrupted or tampered
Comprehensive Audit logs
The Software developed or customized will provide two types of
audit logs.
- File Level Audit Log.
- Application Level Audit Log.
File Level Audit log keeps track of different data processing
techniques that have been applied by different users on a
particular file with time stamp and user information.
Application Level log keeps track of
- Unauthorized user access.
- Time of Login and Logout.
- Creating and Deleting Files.
- File Access Information.
Electronic Signatures
The developed or customized software contains tools that let you
apply electronic signatures to data files. Signer’s credentials
are recorded, as a part of signature. The electronic signature
will be generated using the MD5 cryptographic algorithm.
For more information email :
technologies@elicoltd.com please
contact us
