DOCUMENT CONTROL SOFTWARE

• Can SOPs be divided into different categories?

For the management of QM documents, the dls | eQMS can manage the three document categories ‘QM manual’, ‘Process instructions’ and ‘Work instructions’. These three document categories reproduce different hierarchical levels of the QM documentation. The QM manual includes universally valid documents such as policies, for example, and refers to the other two underlying hierarchy types for a detailed definition of operating instructions.

• Can a numbering scheme for SOPs be configured?

By means of a numbering scheme, a unique number can be assigned to each document in the dls | eQMS. Hierarchical numbering is also available here, which has an impact on the release processes. For example, an attachment created with a hierarchical numbering system  can only be released if the superordinate document is released.

• How are further applicable documents and attachments managed?

One or more further applicable documents and/or attachments can be assigned to a controlled document. They are listed in the document properties and in the preview and can also be accessed directly here.

You can configure that the author of a document receives a notification when a further applicable document or attachment is released in a new version.

• Can the document circulation be configured?

Document circulations (e.g. review, approval, release, training, setting effective) can be flexibly configured and adapted to your company requirements. The document circulation is linked to the document template; thus, a different document circulation could be defined for each template.

• Can specifications be set regarding the selection of persons for the circulation steps?

You can determine whether and which employees and/or employee profiles can be selected in each individual step. You can also determine whether a minimum or maximum number of people are involved in a step and specify a particular person/profile or make it mandatory.

• Are released QM documents automatically set effective?

Setting a document effective is always the last step in a document circulation and usually takes place automatically at the end of the scheduled training period. However, it is also possible to set documents manually effective.

• Can the document circulation be supplemented by a periodic review?

In a document circulation, you can decide if you want to have a periodic review task sent. If a periodic review is planned, the releaser receives a date proposal based on the configuration (e.g. 2 years after the document has been set effective) and a periodic review task is sent appropriately in advance.

The task for the periodic review can be sent to different persons or activity profiles (e.g. reviewers, approvers, releasers).

• How is the signature implemented within the document circulation?

An electronic signature is implemented for all actions requiring signatures (document circulation, read-and-understood tasks etc.). It meets the requirements of the FDA and the GMP guidelines and replaces the personal signature on a printed document. This feature enables responsible persons to provide the necessary signatures even at a distance. Each signature is recorded in the audit trail and printed on an additional page with the document.

• Are all versions of a controlled document managed?

Controlled documents are managed in a minor and major versioning. There may be multiple editing versions if the review/approval/release has been rejected in the document circulation. The author creates a new processing version and restarts the circulation. All versions of a controlled document can be viewed by authorised users. A direct document comparison of two versions is also available here.

• Can a document be edited by several employees?

A document is assigned to an author to whom editing is reserved. However, authorship can be transferred to another employee so that they can add further content if necessary.

• How do employees receive QM documents?

Independently of the additional features in the ‘training management’, you can store a document distribution list on the basis of which the list ‘Binding for’ for a document is created. If document distribution is used, a first distribution list is specified in the document circulation. In the first distribution list, those employees are selected who will receive the task for the read-and-understood training after the document is released. In connection with the processing of this task, a sub-distribution option is available. The employee can distribute the document to other employees in connection with the read-and-understood training.

• Are printouts of a controlled document documented?

With appropriate authorisation, an employee can print controlled documents. During controlled printing, the employee selects the extent to which the document should be printed (additional pages with audit trail information, electronic signatures etc.). A printing reason must be specified and the printout is logged in the properties.

If the printout is reported as returned/destroyed, this is noted in the system using the function ‘Confirmation of printout return’.

• How can document control improve the lifecycle of documents and records in a company?

Document Control improves the lifecycle of documents and records by ensuring that all documents and information are controlled systematically and efficiently. A DMS supports these processes by organising the entire lifecycle from the creation and archiving to the disposal of documents and records. This leads to improved documentation and seamless integration into the company’s quality management.

• Why is Document Control important for managing information and changes in a company?

Document Control is essential for the management of information and changes, as it ensures that all documents and information are correctly documented and monitored. With a DMS, changes and important records can be tracked seamlessly, which increases the quality of the information. This is crucial for reliable quality management and helps the company to ensure a high level of accuracy and consistency in its processes.

• How does Document Control contribute to the effective archiving and management of documents and records?

Document Control contributes to the effective archiving and management of documents and records by implementing processes that ensure the correct handling and storage of all documents. A DMS enables companies to manage documents and information centrally, which simplifies archiving and management. This supports documentation and ensures that all documents are correctly controlled and available throughout their entire lifecycle.

• What advantages does a document management system (DMS) offer in the context of Document Control and process optimisation?

A DMS offers numerous advantages in the context of Document Control by improving process optimisation and the management of documents and information. Electronic archiving and the central management of records enable companies to make their documentation more efficient and transparent. A DMS supports traceability and quality management by organising and making accessible all changes and important information.

• To what extent can efficient document management improve knowledge and information within the company?

Efficient Document Control can significantly improve knowledge and information within the company by ensuring that all relevant documents and information are correctly controlled and documented. A DMS facilitates access to important records and information and stores changes in a traceable manner. This promotes internal knowledge, optimises processes and improves quality management, as all employees always have access to up-to-date and accurate information.

• What role does Document Control play in the risk management process and how is information controlled?

Document Control plays a key role in the risk management process, as it ensures that all relevant information is systematically controlled and centrally administered. Thanks to a clearly structured process, all documented risks are precisely recorded and crucial information is made available at all times. This organised management of information helps to identify potential risks at an early stage and initiate appropriate measures, thereby optimising overall risk management.