DMS, Electronic Document Management Software(EDMS)
AmpleLogic Electronic Document Management System (EDMS) or DMS is a computerized system that allows you to create, capture, organize, store, retrieve, manipulate and control the flow of documents in the electronic format. Designed with a unique tracking system, it aids in keeping the version controls on files that have been modified, re-modified and stored for future purposes.
This electronic data consists of emails, adverse event reports, complaints, batch records, quality control records and many other which are stored electronically. A document management system is designed to automate a business process which involves capturing of paper documents to ensure that an end user can retrieve the copy of paper document from their computer
AmpleLogic designed and developed an Electronic Document Management Software (EDMS) as a solution for industries to curb documentation issues such as improper documentation, obtaining signatures and deliberately avoid conflicts and loss of data.
The Document Management Solution has been designed to be compliant with FDA 21 CFR Part 11 including Electronic Signatures, password authentication and immutable Audit Trails. Standard Operating Procedures (SOPs), Policies, manuals, work instructions, files and reports are created and controlled in a dynamic way in compliance with global regulatory mandates
Features of AmpleLogic Pharmaceutical Document Management Solution
Smooth Document Archival
- The EDMS was designed to deliberately supersede previous versions and obsolete them when the new version is approved and smooth document archival can be achieved.
- Termination of document is also available to scrap the unnecessary documents
- AmpleLogic Document Tracking System also keep track of documents based on their status such as terminated, obsolete or Superseded documents
- It has a separate workflow for a template, annexure and SOP’s which can be defined for every type of file.
- This Electronic Document Management Software has a robust search feature for all records with a flexible and transparent retrieval policy at any point in time.
- You can raise request for document retrieval and it is processed through organised work flow before the retrieval of requested doc.
- AmpleLogic Document Control Software consolidates and accommodates multiple word files no matter the number into a single pdf with no alterations or editing on the uploaded data.
Advanced printing capabilities
- This DMS Software has the ability auto-print selected controls with exact positioning which helps to define and configure file format according to specific requirements.
- AmpleLogic Document Management Software (DMS) is designed with a easy and secured work flow for both printing and downloading the document through which you can keep track of all the printed and downloaded documents.
- Print option will be disabled, once the print has been initiated for the first time for a specific document to prevent any misuse.
- Reprint Option is an additional feature which allows to print the doc when there is failure or error occurred while printing the Document.
- Print taken time and ID will be captured on hard copies while printing any document for the purpose of data integrity.
- You have the feature to view the print summary report which helps you to track each and every detail of documents printed.
- AmpleLogic DMS provides a platform that allows for documents to be edited easily and be re-uploaded after editing.
- Controls such as Font style, size, and numbering format selection are easily accessible.
- Our DMS System makes It easy to review and comment on the document by different users at the same time.
- You can define document format by customizing the header, footer and page signatories as per your preference.
- An activity stamp will be generated whenever a change or activity is performed in a document which helps to keep track of details such as when, where and by whom the activity had been performed.
- With an paper-based document control process, there is no mechanism to stop a user from inadvertently using unapproved documents. With AmpleLogic Pharmaceutical Document Management system, revision control is automatic, so only approved documents can be released.
- Any outdated documents are automatically can be archived, and documents in the process of revision are locked. The system provides a time-stamped audit trail of all changes made to a document
Unique Reporting Abilities
- AmpleLogic DMS unique reporting abilities as it automatically generates all forms of reports, graphical representations, and dashboards which assists management to easily make decisions as regards the organization.
- Automatic emails, reminders and escalations will be generated as per document revision, review and approval needs.
- You can also view the details of revision schedules and deadlines of every document. You will receive timely alerts, notifications or emails regarding the revision time lines when the deadline is approaching to avoid any miss.
- It allows for reviewers to make comments and inferences on documented reports.
Compliant with specified regulations
- This Document Tracking System also complies with 21 CFR Part 11 requirements for document control software including complete audit trails, electronic signatures, etc.
- This web-based system for pharmaceutical document management gives employees in different geographical locations and time zones easy access at any time from a web browser that is secured.
- AmpleLogic EDMS System gives room to identify, compare, manage document versions and make applicable changes to documents including the reasons for changes done, when it was approved, who approved it, and the approver’s signature.
- Advanced search feature is provided to locate or quickly find the required doc, through key search phrases which are related to document.
Some of the Document Management System Challenges
For instance, in the face of an unintended occurrence or disaster like a fire outbreak, important files may be destroyed or mutilated in the process and these files may not be retrieved anymore.
For companies with a very wide scope of operations and geographical coverage, huge volumes of data are created and stored in different locations and departments. It is pertinent that the content is centralized and organized in a way that maximizes its functions to multiple users across the organization. Ensuring document data transparency remains the key factor.
Whenever there is an SOP (Standard Operating Procedure) or changes made, then it must be done carefully with an increase in change request. Hence, SOP tracking and document versioning which is very critical, is done manually with each process.
In other cases, there is an unplanned audit, whereas a new machine is installed in the plant without any information about the SOP of the instrument, and however it will reduce the confidence of an auditor on the organization.
However, whenever there is a critical update Review like updating an existing document made by a personnel without being aware of the absence of reviewer and approver of the document, there might be a delay in the entire production process which will in turn incur a lot of operational costs.
Benefits of AmpleLogic Document Tracking System
Simplified Document Creation
- Variety of documents are available such as SOP’s, Protocol’s, Batch Master Copies, Templates and Annexures.
- Predefined templates for different document formats are available for users to choose from.
- Each type of document is treated differently and can be assigned for its own unique routing. Those types of files may be consisting of separate approvers, managers, and workflows.
- This automated document control software contains addresses of each file type and assigns the appropriate workflow to it.
- The standard template can be created for each individual SOP which can be stored and used for further reference.
- Whenever there is an update in a previously created document, there is a need to compare both versions, therefore it can be useful.
- Each Standard SOP is defined or identified by a unique number mapped with a specific numbering format.
- We can maintain separate numbering formats for SOP’s, Batch Master Copies, and Annexures that helps to keep tracking purpose.
- Each training has a different Print management assigned to it by the issuance of an uncontrolled copy. Print access can be defined for every individual based on the user’s role access.
- Whenever the print got stopped due to some external issue, we can have an option of additional page printing to start printing from where it has been terminated
Integration with Learning Management System
- Whenever there are changes made to a specific document, employees are informed of new procedures and specifications and to be trained on new revisions that are released. A Document Control Software that integrated with a Learning Management System easily helps to define who needs training on it.
- Our 21 CFR Part 11 Compliant Document Management System will also automatically update all training records, employee status upon completion of training and allows for self-training.
- AmpleLogic Document Control System is an integrated solution that connects all quality systems like CAPA, change control, audit, market complaint, and training etc.
Makes Audit Easy
- Incessant compliance mandates, audits and record keeping bestowed on Pharmaceutical companies is a huge responsibility and should not be taken likely. Audits are made very easy when one is always accessible and hence, aggregate information is easier to compile and due dates are managed.
Reduced storage Space
- Ample space required to store files can be managed effectively by an electronic document management system. AmpleLogic DMS also accommodates storage of SOP’s, Protocol’s, Batch Master Copies, Templates and Annexures.
Our easy to use and simple interface and high flexibility allow businesses of any type and size to implement it to their document management needs. This is why our AmpleLogic Document Management System (DMS) is being successfully adopted across all the industries that wish to go for paperless.
DMS can be integrated with the Batch Record Management System (BIMS) and implemented at more than 16 US FDA plants.