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Track Processes: CAPA, Change Control, Deviations
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The Process inter-linked module lets you track and monitor quality events such as CAPA, deviations and change control, using a flowchart approach clearly assigning responsibilities and time lines at each step. Documents and processes can be easily linked.
SOLABS’ QM architecture is anchored around due dates and follow-ups. This allows the creation of productivity metrics such as:
- Traceability: who has done what and when, what is late, etc.
- Real-time information on closed/open processes
- Quality process status
FEATURES
CAPA
You can use SOLABS QM system to electronically initiate and track your Corrective and Preventive Action procedures and report them. Supporting documentation, such as external reports and pictures can be attached and ad-hoc tasks can be assigned to implement corrective actions.
Complaints Management
From the very moment a complaint is received, you are able to track the process and effectively answer, store the information for trending purposes and improve your compliance level to customer service.
Change Control
Avoid manufacturing delays due to unapproved or delayed change control forms by implementing an electronic and standardize Change Control process to better track and expedite change review process, whether it is for documentation, equipment or manufacturing.
Deviations, Non-Conformance, OOS and more
Manage and automate all steps in a non-conformance process to ensure consistency. You can add clear metrics, standardize processes and time lines and monitor progress at all time.
Auditing
Create audits' observation tasks and assign responsibility while maintaining traceability and accountability.
Annual Product Review
According to 21 CFR 211 annual product reviews are required. Requirements include:
- Written procedure
- Review of every batch (or representative) to determine the need for changes in specifications or manufacturing or control procedures
- Review of complaints
- Review of recalls
- Review of returned or salvaged products
- Review of investigations
SOLABS QM system helps you implement APRs and conclude if changes are required in the product specifications, manufacturing or control procedures.
User Definable System
Forms, text field, pull-down menus and field for input are entirely user definable. SOLABS QM adapts itself to your requirements; not the other way around!
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