Incident Management Software
Best Incident Management SoftwareIncident Management Software
Benefits
Software is ideal for Pharma, It creates a paperless and automatic incident procedure which saves time, improves efficiency and eliminates all the manual entries. Software helps to reduce workload, improve efficiency, and provide the essential platform for companies looking to create and sustain an effective incident program. Software have familiar user interface so all operators can quickly learn and navigate through the applications. This helps fast, straightforward implementation and integration . It helps you plan, manage and document calibration work. Designed for all types of instruments which provides compliance for ISO 9001, FDA, GMP/ GAMP, 21 CFR Part 11.- Comprehensive User Management which covers User creation/disable, Password Policy, Group Privilages, Password Reset etc..
- Comprehensive Audit Trail which record each & every activity
- Incident can be raised for various activities e.g. - Product/Material/Equipment/Area etc...
- Auto Incident No. will generate with Target Date
- incident goes to reviewer for investigation once investigation completed he/she will type investigation remark along with Investigation Started On and Investigation End on Date & Time
- Allocation for department comments.
- Department Comments
- QA Manager will review the above all activity and decide about Type of Error (Critical, Major, Minor) along with conclusion
- QA Manager has facility to Accept or Reject the Incident
- Software has provision to generate Deviation & CAPA from Incident
- Incident Verification stage he/she will add corrective action on incident, evaluation on earlier work and verification and action and submit for verification review
- Incident Verification Review stage he/she will verify the verification process and ensure that incident will close and the final remark.
- If Incident is not completed within Target Date, Then It will be locked.
- Facility to Set Extend Target date.
- After Extension Date Review, You are able to perform activity.
- Reminders to Users provided prior a week for the Incident which has Target Date closer.
- Incident Trend Analysis
- Report Generate such as Incident Report, Register, Status, Summary, Department Comments Pending, CAPA & Deviation from Incident
- Report Reflect with E-signature , Reviewer Date & Time & Reviewer Remarks.
- Software can be used via PC’s , Laptop’s and Tab’s
- Facilate to implement core functionality across sites , which helps you to achieve uniform quality practices
- We provide complete evidence of validation execution includes Installation Qualification, Operational Qualification, System Security,21 CFR Checklist , Risk Assessment, Backup Restore Validation, Disaster Recovery