Every Module Question in One Place

NeuSoft can manage policies, SOPs, work instructions, forms, specifications and supporting quality records.

Yes. Native Word and Excel import is included so that existing documents can be moved into the controlled environment.

Yes. Version control preserves the document history and supports authorised rollback to a previous version.

Yes. Review and approval routes can be configured according to document type, department, role and organisational requirements.

Yes. Audit trails record document actions, including changes, reviews, approvals, signatures and status updates.

Yes. Role-based access controls determine which users can view, create, edit, review, approve or manage documents.

Yes. Electronic signature controls are included for document review and approval activities and are intended to support applicable 21 CFR Part 11 requirements.

Yes. Obsolete documents remain preserved as historical records but are separated from current effective documents.

Yes, the Risk Management File structure is designed around the risk management process defined in ISO 14971:2019.

Yes, severity and probability criteria can be configured according to the organisation's risk management procedure.

Yes, it includes a pre-populated library of common medical device hazards, with the ability to add product-specific hazards.

Yes, the system maintains traceability between hazards, risks, control measures and verification evidence.

Yes, residual risks can be evaluated and documented after implementation of risk control measures.

Yes, a structured framework is provided for documenting risk-benefit evaluations where required.

Yes, risks can be linked with relevant design inputs, design outputs and supporting evidence.

Yes, CAPA activities can be linked with applicable risks to support review and maintenance of risk-management information.

Yes, risk information maintained within the system can be compiled into structured risk management reports.

NeuSoft supports design planning, inputs, outputs, reviews, verification, validation, transfer, design changes and DHF management.

Yes, user needs and intended use information can be documented and connected with applicable design inputs and validation records.

Yes, the system maintains traceability between design inputs, design outputs and supporting evidence.

Yes, design inputs and outputs can be connected with applicable risk-management information.

Yes, design reviews can be scheduled at defined stages and linked with the Design Plan.

Yes, design review records can include meeting minutes, action items, approvals and sign-offs.

Yes, verification activities can be linked with design inputs and outputs to generate a Design Verification Matrix.

Yes, validation activities can be connected with applicable user needs and supporting validation records.

Design changes can be managed through controlled change requests, impact assessments, approval workflows and version history.

Yes, NeuSoft supports Design Transfer Checklists, record linkages and required sign-offs.

Linked design artefacts can be compiled into a structured DHF using a predefined folder structure and monitored through a DHF dashboard.

Yes. Deviations can be connected with complaints, audits and other related quality events.

Yes. Separate workflows can be configured and managed.

Yes. The system includes 5-Whys and fishbone diagram templates.

Yes. Automated notifications and escalation help track overdue activities.

Yes, the Training & Competency module is designed to link with an LMS and connect learning activities with employee training records.

Yes, each employee profile can maintain its own training history, assignments, completion status and supporting records.

Yes, training requirements can be defined by role or function and automatically assigned to applicable employees.

Applicable training can be automatically assigned to affected employees when a controlled SOP is revised.

Yes, competency matrices can be created according to job roles or organisational functions.

Yes, organisations can use structured workflows to evaluate and document the effectiveness of completed training.

Yes, training due dates can be tracked and automated reminders can be generated for upcoming or overdue assignments.

Yes, training certificates can be generated and maintained as part of the employee's training record.

The dashboard can provide visibility of training compliance, completed assignments, pending activities and overdue training.

Yes, audits can be planned, scheduled and monitored through a central audit programme.

Yes, the system includes pre-configured ISO 13485 clause-based audit checklists.

Yes, findings can be documented and classified according to defined severity levels.

Yes, photos, documents and other supporting evidence can be attached to relevant audit findings.

Yes, findings and related follow-up actions can be assigned and tracked through completion.

Yes, applicable non-conformities can be linked directly with CAPA to maintain traceability between the finding and corrective action.

Yes, audit information, findings and supporting records can be compiled into structured audit reports.

Yes, follow-up activities can be tracked and verified before findings are formally closed.

Yes, the effectiveness of completed actions can be evaluated and documented within the audit workflow.

Yes, the audit schedule can be displayed in a calendar view to provide visibility of planned and completed audits.

Yes, equipment and instruments can be maintained within a central inventory with their related asset information.

Yes, calibration schedules can be created and tracked for applicable equipment.

Yes, completed calibration activities and related records can be maintained as part of the equipment history.

Yes, calibration certificates can be attached to and stored with the relevant equipment record.

Yes, calibration due dates can be tracked and notifications can be generated for upcoming or overdue activities.

Yes, maintenance activities can be scheduled and their history maintained within the system.

Yes, structured investigation workflows can be initiated when equipment is identified as being outside defined tolerance limits.

Yes, equipment qualification status, including IQ, OQ and PQ, can be recorded and monitored.

Yes, usage records can be maintained for equipment where such traceability is required.

The dashboard can provide visibility of equipment status, calibration and maintenance activities, qualification status and out-of-tolerance records.

Yes. NeuSoft allows supplier controls to be assigned according to the assessed level of supplier risk.

Yes. Pre-configured agreement templates can be used and supplier agreements can be maintained within the system.

Yes. Supplier control activities can be planned and tracked through defined schedules.

Yes. Supplier-related data can be analysed to identify trends and support ongoing supplier evaluation.