Record the quality issue
Capture deviations, complaints, nonconformities, supplier issues, evidence, ownership and immediate actions.
Pharmaceutical quality
Pharmaceutical CAPA Software for Quality Teams
Manage deviations, investigations, complaints, nonconformities and corrective actions in one controlled system, with clear ownership, evidence, approvals and effectiveness checks.
Designed to support pharmaceutical quality systems, GMP and ICH Q10 requirements.
No credit card · No sales call · No time limit
- GMP quality processesManage deviations, investigations and corrective actions through controlled workflows.
- Structured investigationsDocument root cause, evidence, decisions and actions in one connected record.
- Complete traceabilityMaintain ownership, approvals, effectiveness checks and history through closure.
Investigate and act
Document root cause, decisions, corrective and preventive actions, approvals and supporting evidence.
Verify and improve
Evaluate effectiveness, approve closure and use CAPA data to identify recurring quality problems.
Keep deviations, investigations and CAPA connected
When deviations, investigations, actions and evidence are managed across spreadsheets, email and separate files, it becomes difficult to maintain visibility and demonstrate what happened.
CAPA Manager connects the issue, investigation, root cause, corrective actions, evidence, approvals and effectiveness checks in one controlled record.
CAPA software supporting ICH Q10 pharmaceutical quality systems
ICH Q10 places CAPA within the pharmaceutical quality system, connecting investigation, root cause, corrective and preventive action and continual improvement.
CAPA Manager helps quality teams manage these activities through controlled workflows, clear ownership, documented evidence, approvals and effectiveness checks.
Investigation inputs
Manage CAPA arising from complaints, nonconformities, deviations, audits, regulatory findings and quality trends.
Structured CAPA
Connect investigation, root cause, corrective and preventive actions, evidence and approval.
Continual improvement
Evaluate effectiveness and use quality information to support management review and improvement.
Manage deviations from investigation to closure
Record deviations consistently, assign responsibility and capture containment, investigation findings, root cause and supporting evidence. Where corrective action is required, actions remain connected to the original deviation through implementation, effectiveness review and closure.
- Consistent deviation records and ownership
- Containment, evidence and investigation findings
- Connected corrective and preventive actions
- Effectiveness review and approved closure
CAPA software for GMP quality systems
CAPA Manager supports pharmaceutical manufacturers in maintaining controlled quality records for deviations, nonconformities, complaints, investigations, audit findings and corrective actions.
Use structured workflows to document decisions, assign actions, retain evidence and maintain a traceable history through review and closure. For US manufacturers, FDA identifies 21 CFR Parts 210 and 211 within its current pharmaceutical cGMP framework.
CAPA Manager supports GMP quality processes; your organization remains responsible for its procedures, validation, training, controls, implementation and compliance decisions.
Controlled quality records
Keep deviations, investigations, attachments, decisions, actions and closure history together.
Action ownership
Assign responsibilities, target dates, reminders and escalation to keep quality actions moving.
Controlled approvals
Record review decisions and electronic sign-off with clear accountability.
Complete CAPA history
Maintain a traceable record of changes, actions, decisions, approvals and closure activity throughout the CAPA lifecycle.
Investigate, prioritize and verify
Apply a structured approach from initial investigation through risk-based action and effectiveness review.
Investigate problems and identify root cause
Use structured investigation tools including 5 Whys and Fishbone analysis to understand why a problem occurred. Keep findings, evidence and decisions connected to resulting actions.
Support risk-based CAPA decisions
Use risk information to prioritize investigations, determine the appropriate level of action and focus resources on issues that matter most. CAPA Manager does not replace a complete ICH Q9(R1) quality-risk-management system.
Verify that corrective actions are effective
Schedule follow-up, record effectiveness evidence and confirm that corrective actions have addressed the problem before approving final closure.
One system for pharmaceutical quality issues
Bring related quality events into a consistent process while preserving the context, evidence and history for each record.
Deviations
Record, investigate and resolve process or manufacturing deviations.
CAPA
Manage corrective and preventive actions through verified closure.
Complaints
Investigate quality complaints and connect findings to corrective action.
Nonconformities
Record quality problems and maintain investigation evidence.
Audit findings
Assign, track and verify actions arising from audits and inspections.
Supplier issues
Investigate supplier problems and manage resulting corrective actions.
Controlled approvals and electronic records
Use controlled approval workflows and electronic sign-off to maintain accountability throughout investigation, action and closure.
Features including controlled access, electronic approvals and record history can support your organization's electronic records and signature controls where applicable. Any use under 21 CFR Part 11 should be assessed against intended use, predicate-rule requirements, validation and your organization's procedures.
- Controlled access and accountable ownership
- Electronic approval and sign-off history
- Attachments, evidence and decisions retained together
- Traceable changes throughout the CAPA lifecycle
Turn CAPA records into quality insight
OOS investigation follow-up
Record corrective actions arising from out-of-specification investigations and retain their relationship to the underlying quality issue. CAPA Manager is not presented as a complete laboratory OOS management system.
Identify recurring quality problems
Use dashboards, Pareto analysis, filters and reporting to identify recurring causes, overdue actions and quality trends for management review and continual improvement.
Keep CAPA records ready for review
Maintain investigation evidence, actions, owners, approvals, effectiveness checks and history in one controlled record, making information easier to retrieve during audits and regulatory inspections.
Bring your pharmaceutical CAPA process under control
Manage deviations, investigations, root cause, corrective actions, evidence, approvals and effectiveness checks in one controlled system.
Start with 2 users free. No credit card, no sales call and no time limit.