DMS

DMS- Document Management Software

AmpleLogic DMS stands for Document Management Software that helps you to store, manage, archive, track or retrieve the files of documents of your company. It comprises tracking the history as well as keeping the version controls on each of the modified and perform all activities in your document life cycle process.

Using the Electronic Document Management helps companies be more efficient, increase productivity, security, minimize errors and reduce costs with respect to the handling facility of an organization. Our EDMS helps to improve the collaboration between the departments, improve workflow, eliminate redundancy all within a single document management solution.

DMS- Document Management Software

BIMS

AmpleLogic’s automated process Batch Record Issuance Management System (BIMS) – A 21 CFR Part 11 Compliant solution with a blend of Document Management and an Issuance Management helping

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AmpleLogic Document Management System Features

  • Access the information anytime, anywhere from irrespective of geographical locations from a secured web browser.
  • This document tracking system will also comply with 21 CFR Part 11 requirements for document control software like complete audit trails, electronic signatures, etc.
  • AmpleLogic DMS has reporting capabilities to auto-generate any customized reports, graphical representation, and dashboards which helps to increase management oversight to make the quick decision making.
  • EDMS System gives you the ability to identify, compare, manage document versions and applicable changes made that includes the reasons for changes done, when it was approved, who approved it, and the approver’s signature
  • Document comments can be given by the reviewer on permitting specific controls dragging for its comment.
  • Our DMS provides word-based editor wherever you will be able to edit the file on the go and re-upload with a click of the button.
  • Font style, size, and numbering format selection allow fetching controls on print as specified.
  • This EDMS can auto supersedes the previous version, once the new version is approved. Revision control and smooth document archival are going to be achieved.
  • It has a separate workflow for a template, annexure and SOP’s 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 at any point in time.
  • This system can consolidate multiple word files into a single pdf with no alterations or editing on the uploaded data.
  • This DMS has the ability for auto-printing of selected controls with exact positioning which helps to define and configure file format according to requirement.

AmpleLogic designed and developed an Electronic Document Management Software (DMS) for all the industries to overcome the challenges such as improper documentation, obtaining signatures and avoid conflicts or loss of data.

In Pharmaceutical companies every activity has within a GMP (Good Manufacturing Practice) and regulated environment like FDA, MHRA, 21 CFR Part 11 and EU Annex 11 is based upon controlled and revision control. Therefore, Document Control is core functioning for Life Sciences companies and exhibiting Compliance and Quality.

AmpleLogic DMS or Document Control Software improves the control access, achieve assured regulatory compliance and resolve all the major challenges are related to this.

This Electronic Document Management System Software(EDMS) also includes administration tools to define the roles for a set of users, control access, level of document security and detailed activity logs. AmpleLogic Pharmaceutical Document Management Software that integrates with all essential easy collaboration, and advanced search functionality into one easy to use solution.

Some of the Document Management System Challenges

For example, when there is a fire accident because of man-made or due to natural disaster and where all the stored most importance are caught fire or maybe leads to losing files

The company’s large scope of operations and its geographical spread meant that huge volumes of data of varied genres are being created at dispersed locations. It is essential that the content is centralized and organized in a way that optimizes its usefulness to multiple users across the organization whereas document data transparency is the key factor.

Whenever there is an SOP (Standard Operating Procedure) is updated or changes made, then it must be done with raising of a change request, therefore each process is done manually as well as there is no tracking of versions and though SOP tracking and document versioning will be critical.

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.

Whenever there is a critical update Review and Updating in the existing that made by documenter without being aware of the absence of reviewer and approver of the document, this may be delaying the entire process which incurs in a huge cost for operations

Advantages of AmpleLogic Document Management Solution

Reduced storage Space

Physical space is required for store the files this can be eliminated by using an electronic document management system. AmpleLogic DMS allows storing SOP’s, Protocol’s, Batch Master Copies, Templates and Annexures.

Simplified Document Creation

There are different types of documents such as SOP’s, Protocol’s, Batch Master Copies, Templates and Annexures and each type will be 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 addresses of each file type and assigns the appropriate workflow to it.

Print Management

Print Management is different for Training, Issuance an uncontrolled copy. Print access can be defined for every individual based on the user 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.

Unique Numbering

Everyone, it has own unique number defined by the system according to the Standard SOP’s mentioned with numbering format, which will be pre-approved. We can maintain separate numbering formats for SOP’s, Batch Master Copies, and Annexures that helps to keep tracking purpose.

Integration with Learning Management System

Whenever there are changes made to a specific document, employees need to be 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.

Makes Audit Easy

Pharma manufacturing companies are subjected to compliance mandates and audits, record keeping is a huge responsibility. When you are 24/7 accessible, aggregate information is easier to compile and due dates are managed, this makes audits easy.

Template Creation

The standard template can be created for each individual SOP which can be stored and used for further reference.

Document Comparison

Whenever there is an update in a previously created document, we need to compare both versions, therefore it can be useful.

DMS can be integrated with the Batch Record Management System (BIMS) and implemented at more than 16 US FDA plants.