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eDMS + Quality

Electronic document management and quality systems automation for GxP-regulated pharmaceutical, medical device, and laboratory organizations.

Solution by InChronicles
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Overview

eDMS + Quality is an electronic document management and quality system automation product developed by Chronicles Research Team, targeting GxP-regulated organisations including pharmaceutical companies, medical device manufacturers, laboratories, and distributors. It is designed to support compliance with GCP, GMP, GDP, and related regulatory frameworks, and is positioned to be accessible for small and medium-sized businesses operating in the life sciences sector.

Chronicles Research Team combines expertise in medicine, pharmaceuticals, and software development to deliver systems that automate quality and documentation processes. The team has experience in GxP audits and regulatory compliance, and validates software before each release to support data integrity and reliable storage.

Core Capabilities

  • Electronic Document Management System (eDMS) for GxP-regulated document workflows
  • Quality Management System (QMS) and Pharmaceutical Quality System (PQS) automation
  • Incident tracking and quality event management
  • Inventory control and supply tracking modules
  • Electronic patient records support
  • Integration with broader Chronicles CTMS modules including eCRF, EDC, eTMF, and logistics

Consulting and Implementation Services

  • Standard Operating Procedure (SOP) development as part of the onboarding package
  • Staff training included with system purchase
  • Systems integration and business process adaptation services
  • Support from personnel with GxP expertise and audit experience
  • Full documentation package provided alongside the system

Pricing and Access Options

  • Free trial access to test key functionality
  • Standard plan with fees based on user count and storage usage
  • Special pricing available for research and educational organisations, including two months free and discounts for large teams
  • Business plans include discounts for loyal customers, flexible payment models, free system updates, and support and training
  • Pay-on-delivery option available for scientific organisations

The product is developed using agile methodology with ongoing client feedback incorporated into releases. Compliance with GxP and FDA security standards is a stated design objective. Organisations can contact Chronicles Research Team directly for a commercial proposal tailored to their requirements.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechMedical DevicesPharma
Development stage(s)
ClinicalManufacturingPreclinical / Pre-Market
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP