DMS-Soft is a mature EDMS (Electronic Document Management
System ) for pharma application with multiple modules where customer
configurations/modifications is easily
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
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
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
for managing Documents issuance, E-Signature approval and printing
oCreation of parent
oCreation of sub –documents (documents
issued in relation to the parent document)
oMultiple versions uploading
to any document (version controlling)
oApproval, E-signature of
oControl deployment and
obsoleting any version
oControl of document
oControl of template / form
·Product Mfg.: for
managing product listing, batch creation and printing.
oControl of organization
oControl of the batch creation,
oManagement 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.
7- Training Compliance Module:
Ensure your workforce is trained, skilled and certified to drive productivity and maintain compliance
8- Documents Module:Relevant Information within Reach – Always