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DMS Infinity

Document digitization, classification, and compliance management with OCR, version control, audit trails, and e-signature workflows for regulated industries.

Solution by SolutionsMax
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Overview

DMS Infinity is a Digitization and Document Compliance Management System developed by PharmaMax Ecosystem Solutions. It is designed to convert paper-based and unstructured document processes into digital, automated workflows, with a focus on regulatory compliance, data integrity, and document lifecycle management. The platform is positioned primarily for the pharmaceutical and life sciences industries, where adherence to standards such as GMP is critical, though it is described as applicable across diverse industries.

More than 80% of business information is estimated to exist in unstructured formats such as scanned forms, PDFs, faxes, and emails. DMS Infinity addresses this by enabling organizations to capture, classify, extract, and act on information from these sources, replacing paper-based operations with automated data and document flows intended to improve employee productivity, service quality, and regulatory compliance.

Document Capture and Digitization

  • Captures documents and data from nearly any source using OCR (Optical Character Recognition) capabilities, converting scanned paper documents into searchable and editable digital formats.
  • Automatically classifies and processes scanned files into a predefined organizational hierarchy, reducing manual sorting effort.
  • Extracts meaningful data from documents to support intelligent and dynamic business processes.
  • Supports digitization services aided by SmartCaptureMax compliance practices specific to the life sciences industry.

Content Organization and Hierarchy

  • Organizes content across a four-level hierarchy: Department, Sub Department, Sub Levels, and Document Class.
  • OCR scanning services automatically classify documents into the appropriate hierarchy based on rules defined by the system custodian.
  • Supports tagging of documents with internal working identifiers by end users to enable faster and more accurate retrieval.
  • Provides searchable databases for quick and efficient document retrieval.

Version Control and Document Lifecycle Management

  • Implements automated version control to manage document revisions and track changes over time.
  • Allows users to view previously saved versions of documents.
  • Supports workflow automation for document creation, review, approval, and obsolescence processes.
  • Maintains a revision history for every approved document.

Approval Workflows and Electronic Signatures

  • Includes a built-in Change Authorization process for each document approval, with support for multi-level approval cycles.
  • Supports electronic approvals via e-signatures for document reviews and acceptance.
  • Provides automatic escalations within approval cycles when approvals are delayed.
  • Allows configurable approval paths based on document types and organizational hierarchy.
  • Supports document containment in accordance with QA practices.

Security and Access Controls

  • Features a meta-based security engine with flexible permission assignment, allowing custodians to define who can view, edit, download, and share documents.
  • Implements role-based access controls to restrict document access based on user roles and responsibilities.
  • Employs encryption and other security measures to protect sensitive information.
  • Maintains a complete document audit trail to control access and support compliance activities.

Collaboration and Alerts

  • Allows employees to flag issues within document content, such as anomalies in statistical data, and route these to the relevant department for action.
  • Supports collaborative document editing and commenting among team members.
  • Raises alerts when a document's review date is approaching; the alert interval is customizable by the custodian from 30 to 180 days.

Hard Copy Document Management

  • Provides functionality to barcode physical dockets and files and associate them with their corresponding electronic documents within DMS Infinity.
  • Maintains an inventory of hard copy documents.
  • Incorporates check-out and check-in functionality for loaner documents.

PowerPacks Module

  • Allows process forms to be customized in real time.
  • Integrates with DMS Infinity, enabling users to work with both legacy digitized documents and PowerPack documents in a single environment.
  • Manages all approved documents securely in one place.
  • Automates version controls and maintains revision history for approved documents.

Compliance and Regulatory Features

  • Supports adherence to GMP standards and other pharmaceutical regulatory requirements.
  • Provides comprehensive audit trail functionality capturing all activities related to document creation, modification, and approval.
  • Includes tools for tracking and managing compliance with industry regulations and standards.
  • Supports development and execution of validation protocols such as Installation Qualification and Operational Qualification.
  • Offers compliance reporting and analytics tools for monitoring compliance metrics, trends, and key performance indicators.

Integration, Scalability, and Accessibility

  • Integrates with Quality Management Systems (QMS) to support processes such as deviations, CAPA, and change control.
  • Compatible with other enterprise systems including ERP platforms.
  • Connects with training management systems to verify personnel training on document-related processes.
  • Offers a mobile-friendly interface for accessing and reviewing documents from desktops and mobile devices.
  • Supports multi-site functionality for organizations with global operations, ensuring consistency in document digitization and compliance processes.
  • Designed to scale to accommodate growing document volumes and user bases.

DMS Infinity is offered as a component of the broader PharmaMax Ecosystem. The platform includes help desk support, user training modules, and regular training sessions to support adoption and ongoing system usage. It is available to organizations in the USA and India, with offices in Princeton NJ, Sacramento CA, Hyderabad, Visakhapatnam, Chennai, and Trivandrum.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
Preclinical / Pre-MarketManufacturing
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP