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Controlled Documents

Centralized document management with version control, approval workflows, electronic signatures, and training tracking for regulated life sciences organizations.

Solution by Simploud
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Overview

Controlled Documents by Simploud is a powerful, digital document management solution designed to eliminate paper-based processes and centralise all of an organisation's critical documents in one secure location. Built for life sciences and regulated industries — including pharmaceutical, medical device, biotechnology, and more — it provides a streamlined platform for managing SOPs, policies, work instructions, legal documents, HR materials, and other controlled documents with ease and confidence.

The platform is engineered to save teams time and effort while increasing overall efficiency. With top-of-the-line security features, sensitive information remains protected, organised, and accessible at all times. Simploud also links controlled documents to related records such as equipment maintenance and calibration, ensuring all processes remain aligned and up-to-date.

Core Document Management Capabilities

  • Centralised repository for all controlled documents including SOPs, forms, policies, work instructions, and HR materials
  • Single-click document creation using a flexible data entry form tailored to specific organisational needs
  • Ability to bring documents to effective status, create new revisions, and manage controlled copies from one location
  • Document metadata management enabling grouping and filtering by type, owner, effective date, and more
  • Linking of documents to related Simploud records such as equipment maintenance and calibration activities

Collaboration and Workflow

  • Real-time collaboration integrated with Microsoft and Google tools, keeping teams in their preferred working environment
  • Flexible review and approval workflows allowing users to manually select one or more reviewers and approvers, or configure the system to add participants automatically based on predefined rules
  • Configurable workflow statuses that determine when electronic signatures and/or comments are required
  • Full audit trail visibility for all signatures and comments applied throughout the document lifecycle

Training Matrix and Compliance

  • Define who must complete training related to a document, along with deadlines and frequency requirements
  • Option to create quizzes associated with specific documents to verify comprehension
  • Access to related training activities directly alongside controlled documents
  • Management of periodic document reviews to ensure ongoing compliance

Oversight and Reporting

  • Holistic oversight dashboard to track training performance and visualise key document-related information
  • Review all SOPs, forms, and documents organised by type, owner, effective date, and other metadata fields

Simploud's Controlled Documents module is built on a secure, scalable, and compliant platform suitable for a wide range of regulated industries. It integrates with existing tools and workflows, supporting organisations in meeting the highest compliance standards without complex transitions or disruption to daily operations.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
BiotechCROMedical DevicesPharma
Development stage(s)
ClinicalManufacturingPost-Market & RWEPreclinical / Pre-Market
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxPISO 13485