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Quality Documentation and Protocol Management

Creation, validation, and distribution of quality documents and SOPs with automated workflows and audit traceability for laboratories.

Solution by Laby
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Overview

Quality Documentation and Protocol Management is a module within the Laby laboratory management platform designed to help laboratory teams create, validate, distribute, and archive quality documents such as standard operating procedures (SOPs), operating procedures, and instruction sheets. It is aimed at laboratory quality managers, administrators, and teams who need to maintain a controlled documentation system and demonstrate compliance during internal or external audits.

The module replaces paper-based or fragmented document handling with a dematerialized system that tracks the full lifecycle of each document and automates the distribution and approval process across relevant personnel.

Document Creation and Organisation

  • Records procedures (SOPs), operating procedures, instruction sheets, and similar quality documents
  • Operates a document verification and approval system
  • Assigns access rights according to role, including editor, supervisor, recipient, and signatory
  • Controls the full lifecycle of a document: creation, validation, distribution, reading, archiving, updating, and versioning

Workflow and Distribution

  • Identifies and selects the groups and profiles to which a document should be automatically submitted
  • Uses automatic workflows to ensure information sharing across relevant personnel
  • Transmits in one click the list of documents to be consulted and approved to the concerned personnel
  • Ensures controlled dissemination of information to the appropriate staff

Monitoring and Audit Support

  • Manages tasks by person for the validation or reading of a document
  • Tracks reading rates by document and provides detailed monitoring by individual employee
  • Displays signatures obtained or pending, with the ability to follow up remotely with collaborators
  • Provides an inventory and quick export of the list of documents currently in force in the laboratory
  • Simplifies internal and external audits and supports automation of staff onboarding

Laby's Quality Documentation and Protocol Management module is part of a broader laboratory platform that also includes an electronic laboratory notebook, inventory and supply management, equipment and maintenance tracking, digital signature, timesheet, and production management tools. The platform is accessible via demo request and is supported by a contact team reachable by phone and email.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechDiagnostics / IVDPharma
Development stage(s)
Research & DiscoveryPreclinical / Pre-Market
Target user(s)
Lab Manager / Core Facility ManagerResearch ScientistQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11