Document Record Management - Quality Management System QMS

Document and Records Management

The foundation of quality management processes is laid with correct and regular documentation. The Document and Records Management Module provides version control of all quality documents, digitizes approval processes and ensures access security. With this module, organizations can easily manage their quality policies, procedures and instructions and make them accessible at all times for audits.

Compliance with international quality standards such as ISO 9001, GMP and GLP is possible with correct documentation. This module systematically stores all documents, ensures the use of updated versions and facilitates access to past documents during audits. Thus, organizations take quality management one step further by providing transparency and security in their processes.

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Document and Records Management Module

The Document and Records Management Module ensures that all documents and records used in quality management processes are systematically created, stored and monitored.

Document Management

Access Management

Approval Process

Archiving

Traceability

Document Management and Version Control

It ensures that all documents related to quality control processes are managed, current versions are tracked and old versions are archived. The aim is to ensure that documents are accurate and up-to-date and to provide access control.

Features

Document Adding and Classification
Version Control
Revision Management
Approval and Publication

Document Adding and Classification
The organization's quality policies, procedures, instructions and record forms are uploaded to the system and classified under certain categories. This arrangement provides fast and easy access to documents.

Version Control
A version number is assigned to each document. Old versions are automatically archived with updates. This allows access to the history of each document and ensures correct version usage.

Revision Management
All changes made to documents are tracked. They are recorded with information about who made them and when. This transparency is of great importance in terms of quality management.

Approval and Publication
Revised documents are sent to the approval process. Only approved versions are made available. This way, all employees can access only valid and approved documents.

Access and Authorization

It ensures that sensitive documents are accessible only to authorized personnel and supports secure data management. The aim is to ensure the security of documents and ensure that only authorized users can access certain data.

Features

User Authorization
Permission Definition
Access History and Monitoring
Privacy and Data Protection

User Authorization
Access to documents is defined according to the principle of role-based access control (RBAC). Each user is assigned access rights appropriate to their role, thus providing access only to the documents needed.

Permission Definition
Documents that users can access are clearly defined in the system. Advanced permissions such as editing and deleting are defined only for specified users, which increases security.

Access History and Monitoring
Who accessed which document, when, all this information is recorded by the system. This history is used in retrospective analysis for auditing and monitoring processes.

Privacy and Data Protection
Sensitive information is protected with encryption and modern security protocols, preventing data from being viewed or leaked by unauthorized persons.

Document Approval and Distribution

Ensures that new or updated documents are subject to the approval process and distributed to the relevant units. The aim is to ensure the use of consistent and up-to-date documents throughout the organization.

Features

Defining Approval Flow
Automatic Notification Mechanism
Approval Process Monitoring
Document Distribution

Defining Approval Flow
Approving users or departments are determined for each document. The process is managed by the system according to defined workflows and responsible persons.

Automatic Notification Mechanism
When a new document is created or updated, automatic notifications are sent to users involved in the approval process. This way, there is no disruption in the process.

Approval Process Monitoring
The stage at which the document is and who reviewed and approved it are tracked through the system. In this way, the process becomes transparent and auditable.

Document Distribution
Approved documents are distributed to authorized persons via e-mail, portal or intranet through the system. In this way, all users can easily access the most up-to-date version.

Document Storage and Archiving

It ensures systematic archiving of old or outdated documents. The aim is to prevent unnecessary data accumulation and to ensure compliance with legal obligations.

Features

Defining an Archiving Policy
Automatic Archiving
Access Control
Storage Period and Deletion Management

Defining an Archiving Policy
The length of time documents will be kept in the system is determined by institutional policies and legal requirements. These rules are defined in the system to support automatic archiving processes.

Automatic Archiving
Documents that have become obsolete are automatically moved to archive folders according to specified criteria. This feature reduces manual workload and preserves archive order.

Access Control
Only authorized users can access documents in the archive. This ensures confidentiality and only the necessary people can access the information.

Retention Period and Deletion Management
Documents that have expired are automatically deleted from the system. In this way, unnecessary data accumulation in the digital environment is prevented and system performance is maintained.

Audit and Traceability

It aims to ensure that documentation controls are carried out completely and that retrospective traceability is ensured during audit processes. The aim is to ensure that audits are carried out correctly and effectively and that the entire document history can be tracked securely.

Features

Preparation for Audit
Audit Reporting
Traceability and Retrospective Control
Post-Audit Improvement Suggestions

Preparation for
Audit Before the audit, it is ensured that all documents are complete, up-to-date and accurate. This preparation process prevents possible inconsistencies during the audit.

Audit Reporting
During the audit, the documents reviewed are recorded by whom and when they were prepared. This ensures tracking of document revisions and transparency of audit results.

Traceability and Retrospective Control
Revision history can be tracked by accessing old versions of documents. In this way, past changes can be evaluated in detail during the audit.

Post-Audit Improvement Suggestions
Improvement actions are planned for deficiencies identified during audits. These suggestions support the continuous development of quality systems.