Quality · CAPA · Audit trail

Quality should not live in an inbox.

Praeventis brings requests, incidents, deviations, CAPAs and changes together in a clear interface. Every ticket follows the right circuit, every decision keeps its context, every change leaves a trace.

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The problem

When quality requests scatter, the evidence disappears.

Teams often get by with emails, shared files and verbal decisions. It works at first; then deadlines, responsibilities and evidence become hard to defend.

Scattered requests Support, change, GDPR, quality or CAPA: each topic ends up in a different channel, with no reliable overall view.
Deadlines hard to see Critical deadlines remain hard to prioritize when tickets are not clearly sorted, filtered and assigned.
Unclear permissions Customer, developer, quality, project manager, administrator: each profile must see and change only what concerns it.
Fragile history In an audit, you have to reconstruct who changed what, why, when and on which project. Praeventis makes that thread readable.
The answer

A simple system to manage sensitive topics without adding noise.

Praeventis turns quality exchanges into structured tickets, linked to projects, enriched with typed comments, tracked by status and exportable with their history.

An immediate view of open actions.

Teams find tickets in dynamic tables: global search, column filters, sorting, pagination, list or card view. Follow-up becomes natural, even as projects multiply.

  • Tickets linked to a project, a category, a description and deadlines.
  • Statuses that can be changed according to each user's rights and role.
  • Comments tailored to the status, the category and the role.
  • Ticket or audit trail exports for reviews and audits.
Praeventis · Explore tickets
Praeventis ticket table screenshot
Ticket view: search, filters, statuses, deadlines
Quality tickets

Every request starts off right.

A ticket asks for the essentials: a clear title, project, category, description and, if needed, visuals. It then becomes accessible to the people concerned.

Support, GDPR, CAPA, quality, enhancement: one framework per topic.

Praeventis avoids handling every request with the same level of formality. Categories steer the workflow, the rights available and the comments expected.

  • Created by customers or by members assigned to the project.
  • Assignment and notification of the user in charge.
  • Every change justified by a reason for change.
  • Closure with the date kept and an optional comment.
Praeventis · Ticket creation
Screenshot of ticket creation in Praeventis
Ticket creation: category, project, description, priority
CAPA

CAPAs keep their level of rigor.

Praeventis puts the emphasis on quality analysis: severity, detectability and frequency give an initial criticality, then a final criticality after action and post-analysis.

From analysis to closure, with the evidence in the right place.

A CAPA does not follow a simple support circuit. It requires an analysis phase, a choice of pipeline, appropriate actions, then a post-analysis to check that the resolution is effective.

  • Criticality calculated on values from 1 to 4.
  • Natural prioritization of the most critical tickets.
  • Support or quality document pipeline, depending on the situation.
  • Closure after final evaluation, with the history kept.
Praeventis · CAPA
Praeventis CAPA management screenshot
CAPA: analysis, criticality, actions, post-analysis
Workflows

The right comment at the right time, from the right person.

Praeventis does more than change a status. Important transitions are carried by typed comments: development, test, project decision, quality analysis, accepted resolution.

01

Opening

The ticket is created, categorized and attached to a project. The users concerned can follow it.

02

Processing

The person in charge develops, analyzes or documents the expected action according to the category and their role.

03

Review

Quality or the project manager checks the resolution and adds the expected comments.

04

Closure

The closing date, the decisions and the related records remain available in the history.

Modules

Everything you need to track, decide and prove.

Praeventis stays deliberately focused: a readable quality core, operational screens, robust administration and exports you can use in reviews.

Dashboard

The entry view for quick access to tickets, projects and open actions.

Tickets

Support, GDPR, CAPA, quality, enhancement requests, statuses and deadlines.

Projects

Organization by project, assigned roles, archiving and access to the related tickets.

Exports

Extraction of a project's tickets and of the history needed for quality reviews.

Audit trail

A detailed history of transactions on tickets and projects.

Administration

Unique accounts, defined rights, settings, lists and access management.

Compliance

Built for environments where history matters.

Praeventis is designed for computerized systems in a regulated context: unique accounts, defined rights, audit trail, HTTPS, backups, risk management and GxP expectations.

Controlled accounts and rights

Each user has a unique account with rights defined by their profile and project roles.

A usable audit trail

Actions on tickets and projects remain viewable and exportable to make reviews easier.

Security and continuity

HTTPS, backups, authentication, password reset and password change are built into the core.

A framework aligned with the expected standards. Praeventis follows the logic of GAMP V, 21 CFR Part 11, GDPR, EudraLex Annex 11, ISO 9001, ISO 13485, ISO 62304 and ISO 14971.
GAMP V 21 CFR Part 11 GDPR Annex 11 ISO 13485 ISO 14971
Resources

Go deeper into a topic.

9 in-depth guides on quality, CAPA, post-market surveillance and the applicable standards.

Validation & GAMP 5 Software categories, V-model, risk analysis and traceability matrix: how GAMP 5 structures a risk-proportionate computerized system validation. PMS / PSUR reports A PSUR links exposure, incidents, trends and actions. Why this data lives in two systems, production and quality, and how to bring it together to produce the report without re-entry. PMS & vigilance PMS plan, PMSR, PSUR, PMCF/PMPF, vigilance and EUDAMED: what a manufacturer must organize after placing a device on the market, depending on its class. ISO 13485 QMS A QMS is not a piece of software: what the MDR, the IVDR and ISO 13485 ask of the quality system, and how to choose which workflows to digitize first. CAPA & non-conformities Correction, corrective action, cause and effectiveness check: structuring a CAPA process proportionate to risk, without opening a CAPA for every deviation. IVDR & IVD Classes A to D, performance evaluation, PMPF, 2027-2029 transitions, UDI and EUDAMED: what the IVDR changes for the data of an IVD manufacturer. MD / IVD traceability What ISO 13485 and the MDR require of lot traceability, the six practical requirements to meet, and a simple test to see where yours stands. Software & ISO 13485 No software is "ISO 13485 certified": what the frameworks require concerns your records and a validation you remain responsible for. MES, QMS, ERP or LIMS Four categories of software that people confuse, four different questions, and a comparison table to identify the one you are missing.

Give your teams quality that is clearer, not heavier.

Praeventis helps you stay in control of tickets, CAPAs, changes and project decisions with the rigor expected in the life sciences.

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