Training management software for regulated companies
Manage training and qualifications in an audit-compliant way on a single platform
With engamp® | training management, you manage training processes in a structured way across the entire lifecycle: from planning and assignment to execution and audit-compliant documentation of all training activities. The solution was developed to meet regulatory requirements in the life sciences industry.
- Central management
- Automated training tasks
- Audit-compliant
How does training management support operations in regulated industries?
More transparency, less manual effort, greater compliance in regulated processes
In regulated environments, it is not sufficient to merely track training from an administrative perspective. At any time, companies must be able to prove employee qualifications, identify pending training, and track changes to training content. engamp® | training management helps centralise the management of training processes, provides transparent visibility of training levels, and ensures audit-compliant documentation of training records.
Advantages of digital training management
Efficient training processes, transparent qualifications, and audit-ready documentation
In regulated companies, structured training management is essential to manage qualifications transparently and meet regulatory requirements. Training must be planned, conducted, and fully documented — including records and audit trails.
01.
Manage training centrally
Plan, organise, and document training activities, schedules, participants, and content in a single system. This reduces coordination effort and creates a consistent data foundation.
02.
Display training levels transparently
Keep track of completed, ongoing, and pending training — at the level of individual employees, departments, or roles.
03.
Conduct training flexibly
Manage diverse training formats, including document-based, in-person, and digital training, with or without exams.
04.
Manage training tasks automatically
Ensure timely completion of training with automated assignments, notifications, reminders, and escalations.
05.
Document training activities comprehensively
Store training records, certificates, and histories in an audit-compliant manner and make them available at any time for audits or inspections.
What does digital training management look like?
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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
Functions for structured and compliant training management
Key features of training management
engamp® | training management enables companies to control training requirements, qualifications, and records in a digital, traceable, and efficient way.
Administration & Organisation
✔ Central planning and management of all training activities ✔ Management of training dates, participants, and content ✔ Digital list of participants ✔ Flexible search and filter options
Implementation & Flexibility
✔ Support for various types of training ✔ Training with or without electronic exam ✔ Documentation of individual and external training measures ✔ Structured organisation of training content and formats
Proofs & Audit compliance
✔ Audit-compliant documentation of all training activities ✔ Storage of training records and certificates ✔ Traceable history of all measures ✔ Export options for audit and compliance records
Qualification & Transparency
✔ Overview of training level by employee ✔ Insights by role, department, and organisational units ✔ Overview of pending, ongoing, and completed training ✔ Export of reports for audits and internal analyses
Automation & Management
✔ Automatic creation and assignment of training tasks ✔ Notifications for new or updated training ✔ Reminder and escalation functions ✔ Automatic update of training level
Regulations
Regulatory requirements for controlled documents
The management of controlled documents is subject to a large number of regulatory requirements that ensure that documentation processes are carried out in a traceable, secure manner, and in compliance with international standards. Some of the most important regulations that must be observed in document control are listed below:
ISO 9001:2015, Chapter 7.5
✔ Requirements for the documentation of information as part of a quality management system (QMS). ✔ Ensuring the availability, protection, control, and updating of documented information.
ISO 13485:2016, Chapter 4
✔ Specific requirements for document control for manufacturers of medical devices. ✔ Requires audit-compliant management of quality documents.
FDA 21 CFR Part 11
✔ Regulations of the US Food and Drug Administration (FDA) for the use of electronic records and signatures. ✔ Requirements for authenticity, integrity, availability, and traceability of electronic documents.
EU-GMP guideline, Annex 11
✔ Requirements for computerised systems to maintain data integrity in the pharmaceutical industry. ✔ Refers to software validation, audit trails, and electronic signatures.
WHO Guidelines on Good Practices in Data and Record Management
✔ World Health Organization guidelines for ensuring data integrity, traceability, and authenticity in regulated industries.
EFG-Votum V11002: Requirements regarding the electronic data storage
✔ Defines standards for the long-term archiving of electronic data, taking into account security, integrity, and access protection.
EFG-Votum V11003: Requirements regarding electronic signatures and initials
✔ Specifies the criteria that electronic signatures must meet in order to be legally binding and tamper-proof.
Regulatory framework for training management
Meet regulatory requirements in training management reliably and transparently
The solution was specifically designed for use in regulated environments and helps you implement training requirements in compliance with standards. Relevant requirements from international regulations and standards are systematically mapped and documented in an audit-compliant manner.
Which companies rely on digital training management?
Inspiring customer testimonials on digital training management
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.
“The introduction of a DMS including the GMP modules controlled documents and Training Management for our entire group of companies at the six German sites was accepted as a major challenge by Digital Life Sciences and mastered professionally and on time. The very good preparation by Digital Life Sciences helped us to implement the modules in a very short time. The employees' acceptance proves the success of the introduction. We are already looking forward to further collaboration on the introduction of additional modules (Change Control) in order to successfully increase our efficiency even further.”
Dr. Cornelia Beier
Head of Quality Management (Aristo Pharma GmbH)
FAQ on Training Management
Frequently asked questions (FAQs) about training management
This guide will help you learn more about our services and their features
Expand FAQs
Training requirements can be defined in a structured way based on roles, departments, or specific tasks. This means employees automatically receive training relevant to their tasks. The system enables versioned tracking and control of all changes to requirements and content.
The system provides full transparency of current training levels at all times and enables a clear assignment between employees and required training. This enables companies to assign tasks exclusively to appropriately trained personnel.
The system automatically monitors training deadlines. Automated reminders and escalation mechanisms ensure that pending training is completed on time. This helps prevent delays and supports compliance with regulatory requirements.
All changes to training content are versioned and fully traceable at any time. Employees can be automatically informed about updated content and reassigned to training as needed. This keeps the training level up to date and compliant.
Recurring training can be defined as cycles and managed automatically. The system schedules training based on defined intervals and updates training status automatically.
All training activities, from planning to completion and confirmation, are comprehensively documented. A complete audit trail provides full traceability of who completed which training and when.
Yes, training processes can be flexibly adapted to organisational requirements. Workflows, roles, and responsibilities can be defined individually to support both standard and tailored training scenarios.
External training can also be recorded and documented in the system. Training records and certificates can be centrally stored and assigned to each employee, creating a complete proof of qualification.
Training management is a central component of a digital quality management system. This leads to qualified employees and supports the compliant execution of quality-relevant processes. Integration with other modules creates a comprehensive and consistent database.
All training activities are centrally and securely documented, enabling instant access to training records and training levels. This makes preparing for audits and inspections far more efficient and reduces manual effort.
Contact Training Management
Are you ready to optimise your training processes?
Learn how to digitally manage training, qualifications, and records in a single platform. Document all training activities in a transparent manner and reliably meet regulatory requirements.
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