Benefits and Features
Cost Effective
Most organizations do not implement a robust CAPA program due to the high cost of some over-engineered applications. Many times CAPAs are tracked via simple spreadsheets and home grown databases which do not meet full CAPA requirements. Ready-CAPA provides a turn-key application to meet your Quality Management needs at a very affordable price.
Complete Validation Package
A complete Validation Package is available with Ready-CAPA to ensure that the application can be ready to use in days versus weeks.
Workflow Approach
Ready-CAPA ensures that open issues are tracked completely to resolution. Built-in workflows allow tasks to be assigned to individuals, including reminders to ensure that the CAPA progresses and follow-ups are completed and documented.
Regulatory Compliance
Leveraging years of Validation & Compliance experience, Interphase Systems has identified, constructed and tested the various documents, procedures and policies required to meet FDA Regulatory Guidelines. Firms governed by regulatory agencies will quickly see the return on their Ready-CAPA investment.
Closed-Loop CAPA Process
Ready-CAPA's Electronic Workflow implements a closed-loop process for:
- Identifying (Document the Issue)
- Investigating (Evaluate the Cause)
- Action Planning (Define Actions to Correct and Prevent Reoccurrence)
- Implementing (Assign and Track Assigned Actions)
- Verifying (Manager and/or QA Review/approval)
- Monitoring (Periodic Challenge option)
- Closing
|