Be it work/process instructions (SOPs), process descriptions, test specifications, operating instructions, contracts or any other document types — you create, revise and sign them all electronically with our “Document Control” module. The document circulation is determined by configuration. Different (single or multilevel) document circulations can be stored for each document template. Thus it can be custimized to your needs and procedures. The system automatically assigns corresponding “Periodic Review” tasks to the appropriate employees. The integrated reminder and escalation management system signals when deadlines and tasks are exceeded. The participation in the automatic document circulation is confirmed by the electronic and GxP-compliant signature. Integrated audit trails for every document increase traceability.
How do you benefit from the Document Control software?
Some features of the Document Control
Which regulations must be observed for controlled documents?
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Frequently asked questions (FAQs) about Document Control
For the administration of QM documents, the d.3 life science client can manage the three document categories ‘QM manual, process instruction and work instruction’. These three document categories show different hierarchical levels of the QM documentation. The QM manual includes general documents like for example policies. For a more detailed description of process instructions, the QM manual refers to the two hierarchical levels below.
The document circulations (e.g. review, approval, release, training, enactment) can be flexibly configured and adapted to the requirements of the company. The circulation is linked to the document template, so a different circulation could be defined for each template.
For the individual steps, you can determine whether and which employees and/or employee profiles can be selected. You can determine whether a minimum or maximum number of people are involved in a step and specify a specific person/profile or make it mandatory.
The enactment is always the last step in a document circulation and is usually performed automatically at the end of the scheduled training phase. It is however also possible to perform the enactment manually.
In a document circulation you can decide if you want to send a task for a periodic review. If a periodic check is planned, the releaser receives a proposed date based on the configuration (e.g. 2 years after the enactment) and a task for the periodic review is sent with the appropriate lead time.
The task for the periodic review can be sent to different persons or activity profiles (e.g. verifier, approver, releaser).
Independently of the additional functions in ‘Employee Qualification Management’, you can define a document distribution list, on the basis of which the ‘Binding for list’ is created for a document. If document distribution is used, a first distribution list is specified in the document circulation. With the first distribution list you select those users who, after release of the document, will receive the task for the read-and-understood training. 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.
A document is assigned to an author who is reserved for editing. However, the authorship can be transferred to another employee so that he or she can add further content if necessary.
Using a numbering scheme a unique number can be assigned to every document in the d.3 life science client. Hierarchical numbering is also available here, which has an effect on the release processes. For example, an attachment created with a hierarchical numbering system can only be released if the superordinate document is released.
One or more further applicable documents and/or attachments can be assigned to a controlled document. They are listed in the document’s properties and in the preview and can also be accessed directly here.
You can configure that the author of a document receives a note when a document or attachment is released in a new version.
With appropriate authorization, an employee can print controlled documents. During controlled printing, he or she selects the extent to which the document should be printed (additional pages with information on the audit trail, electronic signatures, etc.). He or she must specify a reason for printing 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 ‘Printout confirmation’.
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 substitutes for the personal signature on a printed document. This function 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.
Controlled documents are managed in a minor and major versioning. There may be multiple editing versions if has rejected the check/approval/release in the document circulation. The author creates a new processing version and restarts the signature circulation. All versions of a controlled document can be viewed by authorized users. A direct document comparison of two versions is also available here.
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