Electronic record and document content management system with 21CFR Part11 Compliance And Electronic record and document content management system with 21CFR Part 210-211 Compliance
To avoid or minimize these risks,
life sciences organizations should
adopt new information management
strategies. The clear and proven
path is the electronic record and
document content management system.
These systems enable the
organization to manage their
information throughout project
inception, creation, review,
processing, transmission, storage,
as well as the archiving and
dissemination phases. This approach
offers a systematic and procedurally
sound approach to the unique needs
of product development and life
cycle management in the life
sciences.
SoluSoft Solution for 21CFR Part 11/
21CFR Part 210-211 Compliance
The electronic form, document or
records that are created, modified,
maintained, archived, retrieved, or
transmitted under any records
requirements set forth in FDA
regulations is part of this
solution. The technical and
procedural controls for 21 CFR Part
11/210-211 Compliance enforce
controls on information access,
change management, tracking,
notification, training, work flow
and administrative controls on
authentication, authorization and
integrity of records.
Benefits of Compliance
Authentication: Authorized users
allowed access to electronic
information
Authorization: Only authorized
individuals can access certain or
complete parts of the information
universe
Change Control: Ability to track
changes to electronic and printed
document records (i.e., changes were
made by: who, what, when, and why?)
Retrieval Tracking: Monitor and
track the retrieval of the
information
Workflow: Proactively manage the
information life cycle from
inception, creation, review,
process, transmission, storage,
archiving, and dissemination
Record Authenticity: Digital
signature provided to maintain
document authenticity and integrity
Long Term Storage: Provide
archiving, retention and purge
capability
Protected Transmission:
Information transmitted from authors
to CRO, to technicians, to
reviewers, and to consultants is
protected via encryption
Business Value
Elimination and minimization of
regulatory risks, fines and process
delays
Increase in credibility due to
regulatory compliance
Minimization or elimination of
patent violations
Organization and management of
structured and unstructured
information
Enforcement of the best practices
to protect the intellectual property
of the organization
