Quality Event Software
One process for all quality-related events
Record, evaluate, and track deviations, CAPAs, findings, complaints, and other quality events in one seamless digital workflow—documented in a structured manner, tracked comprehensively, and always audit-ready.
- Real-time overview
- GxP-compliant & audit-ready
- Workflows & Escalation
How does a Quality event provide help you?
Efficient and digital event management
Optimise your quality management processes related to deviations, corrective and preventive actions, complaints, and findings with intelligent digital workflows. engamp® | quality event consolidates these previously separate processes into a single solution and completely replaces manual, paper-based processes — from reporting and evaluation to documented completion.
Thanks to automated workflow control, you can keep track of ongoing events at all times. The system forwards each process to the competent authority after each step; if deadlines are missed, a reminder and escalation system is triggered, and an integrated substitution management ensures seamless processing even in case of absences.
What does a Quality Event entail?
Four types of events, one end-to-end process
Instead of using separate, isolated solutions, you can edit all quality-related processes within a unified, interconnected workflow.
Deviations Deviation Control
Deviations
Identify, evaluate, and correct products, processes, equipment, or documents that do not meet the specified requirements. Every deviation is systematically recorded, subjected to a risk evaluation, and tracked until a decision is made on how to proceed.
Complaints Complaint Management
Complaints
Systematically and transparently record and process complaints related to drug safety and pharmacovigilance—from the report through the initial evaluation to the definition of measures and completion of the complaint.
CAPA Corrective And Preventive Actions
CAPAs
Permanently eliminate non-conformities (corrective actions) and prevent potential errors before they occur (preventive actions). By analysing root causes, planning corrective actions, and conducting an effectiveness check, you ensure consistent product quality.
Findings · Observations & Complaints
Findings
Document observations and findings from audits, inspections, and internal verifications in a structured manner, and track them—with clearly defined responsibilities—through to finishing the evaluation and implementation of corrective actions.
Everything is interconnected: A complaint can directly lead to a deviation, which in turn can lead to a CAPA, and that can lead to a change control. This creates a continuous, traceable chain of interconnected individual processes — from the triggering event to the implemented measure.
Advantages of Quality Event software
What benefits does engamp® | quality event offer you?
Consolidate your quality-related events into a single solution—and ensure that all regulatory and internal requirements are reliably met.
01.
Regulatory compliance
All processes are conducted in compliance with applicable regulations and internal guidelines—such as FDA 21 CFR Part 11, EU GMP, or ISO 13485.
02.
Centralised recording of all event types
Deviations, CAPAs, complaints, and findings are created, tracked, and closed within a single system rather than in separate tools.
03.
Traceability & cross-referencing
Related processes can be connected together—to create a seamless process chain that can be traced at any time.
04.
Data integrity
Event reports are stored electronically from the very beginning and are no longer lost. Data remains protected against loss and tampering.
05.
Process security
The workflow system forwards each process to the appropriate authority after each step. Automatic escalation prevents delays.
06.
Transparency
Authorised employees can view the current status of all events at any time — regardless of their direct involvement in the process.
07.
Constant availability
Access relevant data anytime, anywhere, and collaborate flexibly whether you're in the office or on the go.
08.
Increased data security
Role-based permissions and modern security standards protect sensitive information from unauthorised access.
09.
Individual configuration
Flexibly customise process steps, labels, and value sets to meet your needs—for quick onboarding training.
10.
Reports and analyses
Create detailed reports and statistics, such as those used to support your Product Quality Review (PQR).
What does digital change control look like?
Get a first insight
Advantages
Advantages of the supplier qualification software
Enhance the quality of your products and minimise risks in global supply chains through comprehensive supplier qualification. Start your success story today!
‘Single point of truth’ for the status of your suppliers
Supplier qualification serves as an essential source of information for transparently and reliably determining the status of suppliers from whom services and materials may be procured.
Representation of the supply chain based on material numbers
The visual representation of the supply chain from materials to the end product creates greater transparency for stakeholders and enables a differentiated view by target country.
Risk-based definition of qualification measures
Defining the required documents based on your risk evaluation ensures compliance with regulatory requirements and avoids missing proofs.
Efficient planning and implementation of audits
Integrated tools for optimised planning and implementation of audits save time and resources and increase the overall efficiency of quality control processes.
Document dossier per qualification
A specific dossier with documents for each qualification documents the current status and enables direct access to proofs, certificates, contracts...
Documented release process
The GMP-compliant documentation of all relevant actions in the audit trail provides the person responsible for the release with a reliable basis for decision-making.
Monitoring of certificates and qualifications
Automatic monitoring and notification of the validity of certificates keep the certification status up to date, prevent interruptions in the supply chain due to expired certificates and help maintaining high-quality standards.
Templates for questionnaires, audit reports and qualifications
Predefined templates for different evaluation processes standardise data collection and reporting, facilitate audit preparation and conducting and increase efficiency.
Features
Some features of supplier qualification
Enhance the quality of your products and minimise risks in global supply chains through comprehensive supplier qualification. Start your success story today!
‘Single point of truth’ for the status of your suppliers
Clear presentation of the supply chain based on material numbers in relation to the end products
Specification of the required documents according to the risk classes of your suppliers
Templates for questionnaires, audit reports, qualifications and much more.
Document dossier per qualification
Efficient planning and management of audits
Monitoring of certificates and qualifications
Features of change management
Key Features of engamp® | quality event
Powerful features that meet all regulatory requirements and sustainably optimise your quality event management processes.
Classification & typification
Detailed categorisation of events by type—partly automated based on the metadata entered.
Distribution lists & Responsibilities
Defined distribution lists for planning, implementing and approving measures
PDF/A Creation & Archiving
Automatic conversion of the form to PDF/A and storage in the eDMS after each step.
Escalation messages
Automatic notifications for delays—within the system and via email.
Flexible task management
Parallel and serial task submission, as well as optional redirection to previous steps.
Integrated substitution management
Ensuring process continuity through automatic substitute assignment in case of absences
Audit trail logging
Seamless documentation of all activities for maximum traceability and compliance.
Add documents
Additional files, such as digital photos or reports, can be attached directly to the process.
Initiate resulting processes
Corrective and preventive actions, change controls, or document change requests can be initiated directly from an event.
Evaluation of laboratory results
Incorporation of laboratory results and ad hoc evaluations to ensure quality standards.
ERP Data Integration
You can reference and use master data from your ERP system.
Measure Templates
Recorded measures can be saved as a template; the due date is calculated based on the specified duration.
What requirements soes a Quality Event meet?
Regulatory requirements met by the Quality Event
Documented traceability, risk evaluation, approval workflows, and escalation mechanisms ensure compliance with applicable regulations.
Which companies use change control?
Inspiring customer opinions about the change control software
Discover how companies in your industry have been transformed by using our software solutions. Read authentic success stories that testify to sustainable growth and innovative approaches.
Digital Life Sciences GmbH supported us with professionalism and expertise in record time when we switched to a new electronic quality management system. Six independent document management systems were transferred to a harmonised, centralised d.3 eQMS. The support for implementing the validation requirements for computerised systems in accordance with GxP and ISO standards is excellent. The modules "Document Control", "Employee Qualification", "Deviation Control", "CAPA", and "Change Control" are in use at SCHOTT AG worldwide. The integration of further quality management tools has enabled the portfolio to be expanded and optimised beyond document control. We are building on the positive experience of working together and will continue this good partnership with further topics.
Christine Strubel
Head of Management System Quality & EHS (SCHOTT AG)
FAQs about the Quality Event
Frequently asked questions (FAQ's) about Quality Event
This guide will help you learn more about our services and their features
Expand FAQs
A quality event consolidates all quality-related events within a quality management system—including deviations, CAPAs, complaints, and findings—into a structured, GxP-compliant process. The goal is to ensure the consistent recording, evaluation, and seamless tracking of every process until its documented completion.
The solution covers deviations (Deviation Control), corrective and preventive actions (CAPA), complaints, and findings from audits and inspections. Additional event types can be configured.
Yes. Everything is interconnected: A complaint can directly lead to a deviation, which in turn can lead to a CAPA, and that can lead to a change control. This creates a continuous, traceable chain of interconnected individual processes.
The workflow administration allows you to configure the labels for process steps, fields, and value sets. The steps themselves are structured in accordance with GxP guidelines.
The key data for each process are stored as attributes in the data record. This allows you to search for and analyse specific events; the results can be exported.
In any of the steps following initiation, a task can be forwarded to another person. The recipient's authorisations are checked automatically.
A process step is always completed with an electronic signature and can then no longer be edited. The “Return” function allows the process to be returned to a previous step — each reversal is documented in the audit trail.
If configured, an operation can be cancelled at any process step. Termination can only be carried out by the process coordinator and requires a mandatory justification.
Yes. At every process step, you can upload attachments and link them to the process. They are stored in eQMS under the appropriate document type and can be viewed by all parties involved under “Documents”.
Contact Quality Event
Ready to standardise your quality events?
Turn potential into success—with a GxP-compliant cloud solution that consolidates deviations, CAPAs, complaints, and findings into a single process.
Would you like us to call you back?
We will be happy to call you back. Please fill out the form below. One of our experts will then get in touch with you as soon as possible.
Are you interested in a presentation?
We are happy to offer you a presentation free of charge. Please fill out the form below. One of our experts will then get in touch with you as soon as possible.
