Validation Lifecycle Management module
enables your team to completely automate validation - from templates to
paperless executions including automation of traceability and risk assessments.
Your team can completely eliminate paper and collaborate with other departments.
Industry standards such as GAMP 5 and ASTM-E2500 are fully supported.
Manage Templates
cSAVE's "smart" templates based on
Microsoft Word enable your template managers to create and manage "best
practice" validation & commissioning templates efficiently. Templates can
be approved, revised and retired through configurable workflows.
Author Documents
Business rules can be enforced by your
managers so that all validation documents are always created from effective
templates. cSAVE's "smart" Word templates let your authors focus on content
rather than format. Documents can be reviewed in a browser which provides
authors' access to annotations in real-time. All validation document types are
supported.
Execute Without Paper
cSAVE's support for Paperless
Executions enables you to execute protocols and test scripts within the
familiar Microsoft Word. cSAVE seamlessly enforces all Good
Documentation Practices and execution business rules. This enables
your executors and reviewers to focus on test data rather than enforcing good
documentation rules.
Manage Deviations Online
Deviations can be created and managed
online. The deviation management module lets your personnel employ data
collected towards continuous improvement programs.
Automate Traceability & Risk Assessments
Traceability and Risk Assessment
features are integrated into cSAVE's "smart" templates. Your
document authors can build Traceability Matrices as they
are authoring., for example, specifications or protocols. They can also
perform Risk Assessments, for example, FMEA risk analysis.
Plan Your Validation Projects
Project Management is fully integrated
into the Validation Lifecycle. Your project managers can manage validation
of new systems or revalidation of existing systems.
Stay Compliant
cSAVE is a 21 CFR Part 11 compliant
application which enables you to fulfill your regulatory and compliance
requirements.
Delivered Validated
We deliver a full set of validation
documents customized for your deployment which means huge savings for you.