DMS-Soft

$ 3,330.00 $ 3,330.00 3330.0 USD

75,000.00 EGP

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Description
Features

What is DMS-Soft ?

DMS-Soft is a mature EDMS (Electronic Document Management System ) for pharma application with multiple modules where customer configurations/modifications is easily implemented

Why To Implement ?

The system eliminates the time wasted in document issuance by implementation of E-signature solution for document issuance ( with controlled signing roles ) , avoiding the need to circulate printed papers for signing , providing a secure electronic archive where your data is protected from loss

Will it fulfill Quality/business Requirements ?

The system is built with GMP in mind to fulfill all requirements set by FDA 21 CFR Part 11 for electronic records , and Data integrity requirements where the system manage to close gaps where many manual systems fails to meet as ( flyer paper generation , serialization , manufacturing batch issuance, use tracking, document version controlling and history of changes )

The system bridges the use of electronic records with paper based systems acknowledging need practical implementation needs for paper based document distribution ( e.g allow controlled printing of SOPs and tracking Distribution )

The system also provide separate module for manufacturing documents , where the system manages the products list , the manufacturing batches sizes , the documents needed for each product and allow controlled issuance of batch documents

The system is built with configurable access matrix allowing all organization users to access the system in controlled manner where only functions allowed for each user are shown on his interface

·         Document Control: for managing Documents issuance, E-Signature approval and printing

o   Creation of parent documents

o   Creation of sub –documents (documents issued in relation to the parent document)

o   Multiple versions uploading to any document (version controlling)

o   Approval, E-signature of each version

o   Control deployment and obsoleting any version

o   Control of document distribution

o   Control of template / form distribution

·         Product Mfg.: for managing product listing, batch creation and printing.

o   Control of organization products information

o   Control of the batch creation, request

o   Management of batch approvals, printing and archival

·         Admin: to handle users’ creation, authorization, printers’ configurations and tracking history (Audit Trail)

1- Audit Management System: Discover and resolve issues by building a continuously improving Quality Management System (QMS) by digitally transforming your audit management process – right from audit planning and preparation to audit report and closure

2- CAPA Module:

Drive continuous improvement (CI) of operations with a comprehensive yet easy-to-use system designed to effectively manage your corrective and preventive action (CAPA) processes.

3- Change management Module:

Navigate the complexity, coordination and execution of the change process lifecycle to drive continuous improvement.

4- Complaint Module:

Ensure customer delight through end-to-end management of complaints from in-take to assessing risks, regulatory impact, quality investigation, resolution, and continuous improvement

5- Deviation Module:

Reduce Cost of Quality (CoQ) from internal failure and prevent product recalls with an automated, data-driven process for identifying and managing nonconformance of both products and processes.

6- Supplier quality Module:

Streamline your supply chain output by integrating quality, safety, performance management and collaboration tools to increase supplier performance while reducing risk and cost.