CAPA Management Software Tool Recommendations for Small Companies

E

ebrachhausen

#1
Does anyone have recommendations based on experience for commercially available online tools to effectively manage CAPA in a small testing laboratory (<=20 employees)? Right now there is 1 location, but the company is likely to expand to several more. There seem to be dozens of tools. Many offer suites of tools that cover CAPA as well as other QMS functions that are just too much for this environment. Any simple, affordable candidates to suggest? Thanks for any help you can give.
 
Elsmar Forum Sponsor

Pancho

wikineer
Super Moderator
#4
Try Bugzilla. Though written to fix software bugs, it works great for bugs of any type. And non-conformities are manifestations of bugs in your QMS.

Bugzilla is free and open source. You can add fields, send automatic emails, etc.
 
Thread starter Similar threads Forum Replies Date
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
P Trending CAPA's in our Management Review Meetings ISO 13485:2016 - Medical Device Quality Management Systems 1
P How CAPA's are trended in Management Review Nonconformance and Corrective Action 1
A Risk Management, complaint handling and CAPA system ISO 14971 - Medical Device Risk Management 5
M Management Team "Actions" vs. CAPA (Corrective Actions) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D CAPA FDA Requirements and Guidance related to the Risk Management File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
L Proposal to Senior Management - Three options for our new CAPA process Quality Manager and Management Related Issues 2
P Issue Tracking and CAPA (Corrective and Preventive Action) Management Nonconformance and Corrective Action 6
M Incorporating Risk Management into CAPA ISO 13485:2016 - Medical Device Quality Management Systems 5
D Quality Management Book On Capa (Corrective Action Preventive Action) Book, Video, Blog and Web Site Reviews and Recommendations 4
I Nonconformities and CAPA Nonconformance and Corrective Action 9
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
F NCMRs and its relation to CAPA Nonconformance and Corrective Action 7
C Projects in the CAPA system Preventive Action and Continuous Improvement 6
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
B Do you use paper or web-based templates for CAPA processes? ISO 13485:2016 - Medical Device Quality Management Systems 3
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
B CAPA - Extensions vs Overdue Nonconformance and Corrective Action 11
G New CAPA Work Flow with Revised 8D Approach Process Maps, Process Mapping and Turtle Diagrams 35
Y Blank Fields on CAPA Form Document Control Systems, Procedures, Forms and Templates 21
V CAPA effectiveness check Nonconformance and Corrective Action 3
Ed Panek CAPA against Notified Body? EU Medical Device Regulations 5
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
N How to monitor the effectiveness of the CAPA system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 16
Q Raising A CAPA on Current CAPA system US Food and Drug Administration (FDA) 3
Z Security for Approvals - Cloud based Complaint, NC, and CAPA systems Qualification and Validation (including 21 CFR Part 11) 8
S FDA requirements and CAPA's Qualification and Validation (including 21 CFR Part 11) 2
J MDR reporting and CAPA thoughts? Classifying Complaints on Risk 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
P Documentation for correction, corrective action, mini CAPA Nonconformance and Corrective Action 9
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
A Can change control can be closed if the CAPA is still open? Nonconformance and Corrective Action 3
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A NCR, NCMR, CAPA, Deviations - Medical Device Distributor Nonconformance and Corrective Action 2
S CAPA Investigation Methods Nonconformance and Corrective Action 3
qualprod Should I initiate CAPA for a nonconformance not recorded? Nonconformance and Corrective Action 25
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
J CAPA and other Log Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
D Any Elsmar members using Traqpath to manage CAPA? Nonconformance and Corrective Action 2
D CAPA - Suggested Action vs Action Plan Nonconformance and Corrective Action 5
A Audit Finding - CAPA, Improvement Initiatives not filed in CAR System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Moncia Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Issue with CAPA system - Should Over Due CAs warrant a CAPA? Nonconformance and Corrective Action 17
K CAPA (Corrective and Preventive Action) - ISO 13485 Nonconformance and Corrective Action 1
M CAPA due to Consumer not following Maintenance Instructions... Nonconformance and Corrective Action 9
A Escalation to CAPA - Assessing if an NC warrants a CAPA Nonconformance and Corrective Action 4
J Software and Methods for Tracking CAPA (Corrective and Preventive Action) items US Food and Drug Administration (FDA) 3
Q Customer Complaint Vs. Nonconformance - CAPA SYSTEM Customer Complaints 2

Similar threads

Top Bottom