Document Management System (DMS)
Documents Management System:
DMS supports a document repository, manages the lifecycle of documents from creation to revisions to obsolete. It includes services such as controls on printing, access privileges and search / retrieve capabilities and provides interfaces to other applications.
Royal Quality Pillars shall simplify the initiate , review and approval of multiple type's documents with well-defined workflows
Automates routing of documents for review and approval to multiple stakeholders; enables cross-functional teams to simultaneously review, approve, and add comments along with robust version controls.
Initiation
Initiate, categorize, links supporting, reference, upload, documents.
Primary and secondary document shall be initiate with link supporting documents Able to upload multiple documents And request is submit without any life cycle section.
Review /Approval
Based on the initiator, allowed to route either the entire document review/ approval for department.
After department review allowed to route either the entire document review and approval of next life cycle users.
Multiple users to review the document at the same time, and add their comments or feedback.
Training
Providing powerful capabilities for document training and awareness. The app helps ensure that training requirements are met and recorded from a compliance standpoint. It also provides employees easy access to a variety of training programs that map to various guidance documents, policies, procedures, regulations, and standards.
Repository, Distribution and Retrieval
It also consolidates documents in a central, globally accessible repository as per role based and lifecycle based. Across the enterprise.
Repository should have the document Master, all superseded version and obsolete document
Auto distribute publish final document for the required groups based on the workflow, Enables users to easily access and accept for control copy print, and also having request based destitution.
Automated notifications to relevant Distribution stakeholders for any document changes and updates.
Reconciliation of the distributed copies during the revision.
Version Control
Modify existing documents, and collaborate with relevant users to improve documents.
Revision having the Provision Minor, Major and obsolete the documents with revision history and audit trail.
Reports and Dash Boards
Graphical executive dashboards and flexible reports and provide statistics and data on Real time reports. by type, status, audit history, in-process documents, approval cycle times, usage summaries, and average review times.
Demonstrable analytics and reports, real-time tracking of the document management.
E-mail Alerts
Notify concerned stakeholders during the flow and after publishing, changing, or updating a document
Search
The app provides you with powerful capabilities to search for documents based on attributes, content, author, and other parameters. The app also has the ability to save previous searches, and allow users to mark documents as favourites, which enables quick access to a set of documents.
Compliance
21 CFR Part 11, GAMP 5 and GxP Compliance
Review of existing business and technology policies and processes
Identification of infrastructure components including network diagram study
Gap Analysis vis-à-vis ISO Part 11, Annexure 11 MHLW & Understanding of Information Security Requirements.
Generate the remediation roadmap and implementation plan
Validation
Computer System Validation Services
Validation Team is Involve the V- Modal Validation from URS User Requirement Specification to Performance Qualification.
Provide the Following Documentation
Master validation Plan
IQ/OQ/PQ plan for individual systems
Individual system documentation (FRS, SRS, SDRS, Design Document etc.)
Test plans and Test cases
Individual systems Test results for individual systems Final validation reports for individual systems System traceability matrix
Services
Gap Assessment of systems before an FDA inspection
Remediation support wherever necessary
Training the required employees with certification
Audit/Certification Support Services
System Integration
Application Integration Architecture (AIA) is an integration framework produced by developers. Standards-based, common objective and services
DMS Advantages
Advantage #1 – Better version control
Advantage #2 – Improved timeliness
Advantage – No more emails
Advantage #4 – Increased document security and control
Advantage #5 – More reliable backups
Advantage #6 – Lower document management and archiving costs
Advantage #7 – Better knowledge management and search
Advantage #8 – Built-in regulatory compliance
Advantage #9 – More consistent content
Advantage #10-Automatic notifications and alerts to simplify document distribution
Advantage #11-Supports electronic signatures on document with accurate time-stamped along with audit trails.
Advantage #12-Scalable system with robust integration capabilities to meet the organization’s requirements
Advantage #13- Any Time Readiness (ATR) for Audit
