A few words on Document Management

Document management systems are one of the core platforms on which an organization is built on, they impact the day to day of practically any employee in the company.

They must be accessible, user friendly and as self-explanatory as possible.

The number of parameters which a system must contain is vast, but I would like to present the main ones.

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Modern Document Management systems are comprised out of?four main parts:

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E-forms?Documents are not only SOP’s and work instructions, a great number the documents used every day are actually forms that need to be created approved and modified once in a while but need to be filled in continuously. A modern electronic system allows not only the creation of the electronic forms but the completion of said form in a paperless manner directly from a mobile phone, tablet, or computer. Each time a form is filled it will be assigned its own identifier, all answers will be recorded with full audit trail, a modern system does not stop there it even creates statistics on responses filed.

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Binders Different documents often need to be managed in conjunction for a specific purpose such as a regulatory submissions, eTMFs, CTDs, validation packages etc. Modern document management systems enable creation of a binder per need and allow for multiple options to manage them such as task assignments via Gant chart, version control and approval of the entire binder (including green lines and red lines), ability to export the binder in its entirety or selected parts.

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Document management core?One would believe that all document management are created equal however in today’s world this is simply not so. A brief example of this would be in the time it takes to start using the system, modern document management systems come ready to use, are pre-configured according to cGMP, GDP etc. pre- validated with a full GAMP5 validation package (IQ, OQ, PQ, URS, FRS, VSR etc.) right out of the box so that you can start working in weeks and not months or years. Should customizations be required they can be done in a very short period of time as you already have a very sound base (which has been audited by a variety of notified bodies) to start from and revalidation, if necessary, will be done only on the delta.

Another attribute that separates a modern DMS is?generative AI capabilities, these are very useful for similarity searches in order to find related and affected documents, predict the time it will take to approve the document according to its type and list of approvers based on historical records.

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Below is a sample list of additional criteria relating to document management core:

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• Alerts when working on documents that are affected or related to other documents.
• Flexible ability to relate documents to additional categories such as suppliers, equipment, product for ease of administration and more importantly PQR.
• Ability to include external parties (suppliers, partners, consultants) to review and approval cycle.
• Review cycle conducted by all reviewers simultaneously whilst maintaining data integrity utilizing imbedded office365 and G-docs integration.
• Ability to predefine reviewer and approver matrix according to document criteria (document type, business unit etc.)
• Manage document translations in synch with original documents.
• Ability to define templates for documents to be used as a starting point for different document types.
• Full view, download print access control and log per document.
• Controlled copy tracking and management.
• Periodic review and effectiveness check
• Full segregation of data by business unit/group or individual
• Ability to create and complete document checklists per type of document.
• As part of document release training assignments and quizzes can be administered to all users either within the system or via connection to external LMS
• Ability to read, approve and review docs via mobile.
• Ability to collaborate and conduct ideation via IM internally using the DMS.
• Ability to manage different workflows for different types of documents controlled VS. self-service (simple) documents.

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Document Change Control?Process?usually a document change order is enough in order to track changes between versions of a document. Criteria such as reason for change and rationale of revision are mandatory fields when sending a new version of a document for approval.

However at times a change will consist of several documents where it would be more prudent to manage them together in a change control where impact and risk assessments can be added, where timelines and dependencies between different documents can be conducted and even more importantly the release of all documents can be done simultaneously once the entire change control has completed its trajectory.

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