Aspen Audit & Compliance Manager™
Ensures data integrity from event creation to database storage,
providing guaranteed event delivery
Aspen Audit & Compliance Manager is an enterprise-level
21CFR11 audit compliance solution. It collects and manages large
amounts of continuous, batch, lot and process data, and integrates
with external lab and quality management systems to acquire product
quality data and associate it with the appropriate batch. It uses
this information to identify deviations and manage the associated
workflows required for deviation review and approval. Aspen Audit
& Compliance Manager is a core element of AspenTech’s
aspenONE® Production Management and Execution
applications.
Features
- Collects all necessary data from the batch process and quality
systems, determines product quality information, and associates
with the appropriate batch
- Integrates with external systems such as LIMS, EDMS, and
MMS
- Tracks manual and automated process steps, operator inputs and
actions, configuration changes defined by the user, and changes
from multiple data sources
- Automates batch release workflow including the routing of
deviation review and approval to appropriate roles for review and
sign-off
- Integrates the workflow with online process data
- Verifies compliance with specifications and documents approval
of exceptions
- Deviations are required to be acknowledged, commented, and
signed off by production and QA
- Generates a summary report of any deviations or missing data
for a batch for mandatory review as part of the compliance
management work process
- During execution of the batch, the operator is able to review,
acknowledge, and comment on deviations
- Once a batch is completed and all deviations are acknowledged
by the operator, manufacturing and QA are required to review and
signoff
- Deviations are incorporated as part of the electronic batch
record, and all deviations must be reviewed and acknowledged before
the batch record can be signed off for release
- A final electronic batch report is generated and stored as
either a PDF or HTML file
Related Products
Benefits
- Automates the audit and compliance process, including the
incorporation of all batch deviations and their associated comment
and signoff history into the electronic batch record
- Enforces the signoff and approval process before allowing a
batch record to be signed off for release
- Single server implementation provides a low-cost,
enterprise-level compliance solution