|
|
Top-down risk-assessment
of all your systems, equipment, and
processes.
Then validation-action
recommendations
based on relative risk.
 |
Inventories & Risk Assessments |
|
|
Record details of your systems,
equipment, and processes, each with
its own risk assessment. |
|
Library of assessment questions |
|
|
Library of pre-defined
risk-assessment questions, tagged by
system type, operational status,
etc. |
|
Risk calculation algorithms |
|
|
Choice of multiple algorithms,
including FMEA, test-availability
gap analysis, linear, and flowchart. |
|
Library of validation actions |
|
|
Customizable
set of validation actions (tests,
documents, etc.), tagged by system
type, operational status, and level
of risk. |
|
Database
|
|
|
All assessment questions,
answers, comments, and remediation
details are stored in an Oracle or
SQL Server database. |
|
Reports |
| |
|
Summary reports (risk, progress,
status) with drill-down to full
details of individual assessments. |
|
Part 11 |
|
|
Authentication; flexible
permissions by user type;
electronic-signature approvals;
audit trails. |
|
|
|
