Scope and use
- Documentation management, including drafting, review, approval, release, periodic review, cancellation, and archiving
- Training management, including tests, test questions, answers, evaluation and scoring of actual answers, re-testing, tracking and documentation of completed and in-uncompleted training, escalation of in-complete training
Controlled documentation
The documentation management process starts with the registration of the document in the system, continues with the creation of the draft, review, approval and release, based on which the document is activated and made available to other users. Once activated, the document can be used for training and actual work. The document can be further revised via period reviews, scheduled or unscheduled, or archived when not needed.
F4 Approval
Document approval with multiple approvers across different roles, setting of document effective date, electronic signature, document version increase by one compared to the previous one.
F5 Active document
The approved document becomes effective, accessible for other users. The training of affected users can be initiated.
F6 Document revisions and archival
Planned and unplanned document revisions, resulting into new versions or document archival.
F1 Document workflow initiation
Document identification number is assigned automatically and metadata entered – Document name, Author, Document type, etc.
F2 Create document
The document is drafted by the author and entered to the system.
F3 Document review
Document review with multiple reviewers. Move workflow to the next phase.
Other modules and functions
Training
The Training system is connected with the Documentation module. For every document/released version, a test can be created. The test consists of questions for which a set of correct and incorrect answers is pre-defined, as well as the minimum percentage of correct answers required. When a test is assigned to a user (via role, group, or individually), the user is prompted for the test. The user answers the test questions, thus meeting or not meeting the required score. When the test is not successfully completed, it can be repeated and/or escalated to a supervisor.
Training evaluation and reporting
The system provides standardized reports on completed and the incomplete tests, either per individual user or by a user group/department. This simplifies the process of proving documented evidence that the employees are trained in accordance with their job description and requirements.
Configurable workflows
Document management and training management can be managed through a number of flexible workflows. Their structure is not limited or dependent on the type of document, the organization of the work teams, the approval panels, or the user roles and approval permissions. This enables the standardization of the document approval process and training, in accordance with the expected company’s quality policy. The automation of the processes enables deadlines to be monitored, human errors to be detected and reduced, and when training requirements are not met, this can be visualized and escalated to supervisors and a higher management.
Audit trail and History
An audit trail and history is maintained for all documents and training records. Due to filters and search functions, it is easy to review audit rail and sign off on the history, if required. All records and worfklow changes are 100% traceable and cannot be falsified or deleted. Undesired records can only be moved to a bin with a rationale. From the bin, they can be recovered or the history reviewed.
DMS/LMS connection with QMS and LIMS
Documents and training can be linked with other QMS and LIMS modules, resulting into one single environment, enabling the complete quality and laboratory management from one validated system that meets all security and data integrity requirements.
Examples EffiChem 5.0 DMS
Dashboard
The desktop is a cross-road from which individual functional modules can be started, including Samples and Results, Controlled documents, Equipment, Reference Materials, Deviations, Changes, CAPA, Statistical data evaluation, etc. The desktop can be individually configured per user for maximum efficiency.
Document management and training
Similar to the Samples module, the Controlled documents and training is the most frequently implemented module. It enables to create, review, approve and publish version-controlled documents and record related user-training. The effectives of training is assessed by means of test questions. When non-complying test results are obtained, the tests might be required to be repeated and/or escalated to the higher management.
List of non-complying training/tests
The training module includes the training effectives assessment. For each document, it is immediately shown, who was to be trained from what, with what result, when, and if anything was done to cover the training gap.
Document detail
The document detail shows the automatically assigned identification number, document name, document type, author, approvers, approval date, effective date, revision periodicity, next revision date, etc. Besides, it enables to define test questions and the correct answers to be used for the training effectiveness check.
Products
Solutions offered
Important links
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