The evolution from Validation to Corporate Compliance - PENSAssure: PENSAssure version 5.0 is now available!
PENSAssure is a Windows-based
software program that offers an expert knowledgebase of compliance and
regulatory information to assist with every kind of validation/compliance
project. Using PENSAssure greatly reduces the cost and complexity
of managing projects due to unique features such as the
Traceability Matrix, electronic approval and signatures and
the preparation of validation/compliance documents.
Traceability Matrix feature allows links to be
- Requirements and tests
- Requirements and design statements
- Requirements and regulations
- Employees and training records
- Requlations and audits
- any item to any other items
maintains the compliance knowledge necessary to
create all validation/complaince documents including:
- Validation plans
- User requirement specifications
- Functional requirements specifications
- Design specifications
- Test protocols and reports
- Final validation reports
- Audit reports
- Training records
- Compliance documents
PENSAssure is also adaptable.
It can be configured by the user to create the
validation deliverables needed for any methodology.
development of PENSAssure was lleveraged off our experience with The Validation Manager (TVM)
and was conducted with Part 11
compliance in mind. Audit trails, electronic
signatures, signature routing via e-amil, digital signatures and other features
are designed and built in as part of the
application. This forethought of compliance will
simplify the validation of the tool.
5.0 is now available!
This version has updates and
Email routing for review and approval.
Embedded object capability; i.e. corporate policies
and procedures, image files, web links.
Reporting capability: select a date range and
report on a number of query options.
Object variables: populate all objects with the
same variable at once, for example site location.
More intuitive use interface.
There's not a validation or compliance tool like it.
the version 5.0 PENSAssure
brochure in Adobe pdf.
you like more details about the PENSAssure product? E-mail
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