to consulting and validation software, PENSA offers
will provide validation training to ensure operators are
qualified to perform assigned tasks which is a great
process to satisfy FDA audits.
Web Seminar - Complying with 21CFR Part 11-Understanding
the Role of Predicate Rules - 29-Aug-2006 - Click
here for more information
following validation courses are offered by PENSA either
in house or at a specified location:
- Validation Basics
This training unit provides the fundamentals required to understand the methodology used to validate a computer-related
system. The concepts introduced in this unit provide the framework
for subsequent training that identifies the specified steps required
to complete the validation of a computer-related system.
- Detailed Validation Methodology
This training unit provides the details required to understand the methodology used to validate
a computer-related system. The details of the methodology discussed
in this unit build on the concepts introduced during previous Validation
Basics training regarding validation of a computer-related system.
- Complete Validation
A combination of the 2 courses listed above.
- Vendor Audit
This training unit provides details required to understand how to perform a Vendor Audit on a supplier of software
or hardware. The information provided in this unit can be used to
assist in performing a vendor audit. Finally, it will provide some
sample questions that can be used during the audit.
- Change Management
This training unit provides the fundamentals required to understand the Change Management of a validated computer-related
system. The information introduced in this unit provide the detail
procedure as well as specific examples to illustrate the steps required
to maintain the validated state of a computer-related system through
- Electronic Signatures and Records
This training unit provides the fundamentals required to understand the regulations identified
in 21 CFR Part 11 for Electronic Records and Electronic Signatures.
The information introduced in this unit allows the participant to
form an interpretation of 21 CFR Part 11 and validate a computer related
system against the necessary requirements.
PENSA has a business partnership with JD Edwards, providers of OneWorld ERP systems. To date we have validated more than 20 installations of OneWorld. Because of this knowledge and experience we can adjust any of these courses to a OneWorld user perspective which can give you the knowledge to do the validation yourselves. PENSA can follow up with an audit to review if you so wish.
To request more detailed information, please e-mail