| Main Functions | |
| FRACAS Control for Specified CA Records | |
| User Configurable Corrective Action Document Report Types | |
| Closed Loop Corrective Action | |
| ISO 900X Compliant Corrective Action Records | |
| Revision Control of All Document Status Reversals | |
| Full Featured Corrective Action Task Planning | |
| Automatic Approval Requirements | |
| On-line Tracking and Electronic Approval Signature Capability | |
| Automated Input of Standard Text for Discrepancies or Audit Findings | |
| Code Segregation Capability by Document Type | |
| Unique Data Collection Capability via Customer Driven Pop-Up Screens | |
| Challenges Addressed | |
| Lost or Incomplete Corrective Action Documentation | |
| Lack of Visibility of Corrective Assignee | |
| Non-standardization of Multiple Corrective Action Processes | |
| Longer than Desired Corrective Action Cycle Times | |
| Lack of Closed Loop Follow-up and Closure | |
| Lack of Trend and History Data for Process Improvement | |
| Multiple Departmental Databases for Tracking Various Types of Corrective Actions | |
TIPQA™ ... Modules ... Corrective Action (CAPA) |
|
| TIPQA™
– Corrective Action Module (CA) automates a formal, closed loop
corrective action / preventative action system for resolving quality
problems encountered in the course of normal operations. CA documents
the history of corrective actions from request through follow-up and
closure including the Failure Reporting and Corrective Action System (FRACAS). This on-line system eliminates the possibility of lost paperwork,
improves accuracy by validating data entry against master records,
and speeds the processing of corrective actions.
Additionally, the automatic e-mail capability can send notification of CAs that are either coming due or are overdue for response and/or corrective action completion. Finally, automated e-mail notifications can be escalated up the management chain, as necessary, to further promote prompt completion of the corrective action(s). |
| Key Features | Benefits |
| Fully Integrated with Multiple Modules |
Eliminates duplicate data entry. |
| Elimination of Multiple Systems |
Reduced system maintenance requirements |
| High Degree of Flexibility of CA Document Types |
CA type allows fitting the CA type to the process versus fitting the process to the CA type. |
| Automated Processing and Approval Requirements |
Automated approval determination based on CA type eliminates missed approvals and/or reprocessing of documentation for approval after the fact. |
| Deficiency Task Planning | Allows development and tracking of multiple dependent and/or independent tasks within each deficiency line |
| Link Documents to Corrective Action | Capability to link multiple associated documents to a CA record |
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