“Dot Compliance has resulted in improved efficiency, giving us greater control, and has enabled us to make data-driven decisions.”
Document Management
Capture, track, and store all of your documents in one place
Join the Industry’s Leading Life Sciences Professionals Who Trust Dot Compliance
Optimize Document Management for Greater Efficiency
Centralize, control, and automate document processes to improve accuracy and stay aligned.
Streamline Processes
Managing documents through emails, shared drives, or paper files often leads to delays and errors. An eQMS centralizes creation, review, approval, and distribution in one controlled system with automated workflows and reminders. Dot Compliance’s document management solution keeps teams aligned, ensuring SOPs, training materials, and batch records move efficiently through approvals while improving visibility and accountability.
Gain Effective Version Control
Version control is vital for compliance, yet paper or hybrid systems often create confusion with duplicate files. Dot Compliance’s solution automates version control with full audit trails, timestamped revisions, and secure archiving. Teams always access the latest approved documents, maintaining accuracy and compliance with FDA 21 CFR Part 11, EU Annex 11, and ISO 13485.
Enhance Compliance and Data Integrity
Compliance relies on accurate, traceable documentation across all stages of the product lifecycle. Dot Compliance enforces access control, approval workflows, and secure electronic signatures to maintain data integrity. Every document action is recorded and auditable, while role-based permissions ensure only authorized users make changes. Integration with Office 365 and Google Workspace enables secure collaboration without compromising compliance.
Dot Compliance’s document management solution is built on industry best practices ensuring compliance with global regulations and standards. Our cloud-based integrated software solution allows life sciences manufacturers to manage the entire life cycle of documents and content.
Why Dot Compliance Document Management
Access documents from anywhere
Employees need the ability to access documents from anywhere at any time. Having a cloud-based system, built on the Salesforce platform gives users web-based access regardless of where they are located.
Easily manage your documents
Allows your organization to create and view documents, see where they are in the review process, what still needs to be added, and whether any additional actions are needed. Having the ability to categorize, tag and rate documents will help you find the files you need quickly.
Seamless integration with Office 365 and Google Docs
Simply integrates with Office365 and Google Docs for easy check-in/check-out and parallel collaboration between document owners, authors, and reviewers.
Adaptable workflows for review and approval
Getting documents reviewed and approved by the assigned people within the organization shouldn’t be a painful process. The ability to modify workflows within the document management system simplifies and speeds up the process.
Total revision control
To ensure accuracy, it’s critical to know which document is the most current. A comprehensive document management system saves every version of a document when it’s uploaded, enabling you to have visibility into the complete version history.
21 CFR Part 11 compliant electronic signature
To stay compliant with 21 CFR Part 11, an eQMS needs to positively identify who is signing company documents. The process needs to provide a time-stamped archive of all signatures, prevent electronic signatures from being modified, duplicated, transferred, or removed, and needs to use signature comments.
Control user access and privileges
It can be difficult to manage disparate quality teams, particularly when it comes to global teams. A document management system allows administrators to set specific permissions for every employee regardless of location, helping to control the process and protect important documents from being altered.
The ready-to-deploy QMS software that delivers speed and smarts
Used by life sciences organizations around the world, Dot Compliance empowers teams to manage quality with confidence, maintain continuous compliance, and keep every process inspection ready.
FAQs
How does the system ensure document control compliance (21 CFR Part 11, ISO 9001, ISO 13485)?
Dot Compliance is purpose-built to meet the most stringent global regulatory standards. The system enforces compliance to 21 CFR Part 11 and relevant ISO standards through secure, time-stamped audit trails, unique electronic signatures with signature manifestation, and robust role-based access controls.
Can we manage the entire document lifecycle, from drafting and review to approval and obsolescence?
Yes. The Document Management functionality includes built-in lifecycles and workflows that manage documents through stages such as creation, review, approval, training, and effectiveness.
Does the system automate periodic review cycles?
Yes. Dot Compliance eliminates the need for manual tracking by automating the periodic review process. Organizations can set custom review intervals (e.g., annually or biennially) based on document type. The system then sends proactive notifications to document owners and quality teams as the review date approaches, ensuring that all SOPs and policies remain current and compliant.
Does the system support tailored headers, footers, and watermarks on documents?
Yes. To preserve document integrity of documents outside the digital environment, the solution’s Document Management functionality automatically generates a PDF for each document. These PDFs can include configurable headers and footers that are dynamically populated using document metadata, as well as watermarks that reflect document status (e.g. Draft or Effective) or data classification indicators (e.g. Confidential or Restricted).
Does the system support collaboration on documents?
Yes. Dot Compliance’s Document Management functionality includes built-in integrations with Microsoft 365 and Google Workspace, allowing teams to collaborate on documents in real-time within a controlled environment. This ensures that authors can collaborate effectively while the eQMS maintains total version control and a detailed audit trail.
How are training records linked to new or revised documents?
Training and Document Management are natively integrated within the Dot Compliance eQMS solution. When a new or revised document is approved, the system can automatically trigger training tasks for the relevant personnel based on their specific role-based assignments. These training records are permanently linked to the specific document version, providing a clear and auditable “closed-loop” between a procedure and the evidence of personnel competency.
Global compliance, baked in
Quality & Compliance Standards
- ISO/IEC 42001 (AI Management Systems)
- ISO 9001 (Quality Management Systems)
- ISO/IEC 27001 (Information Security Management Systems)
- GAMP 5 (Good Automated Manufacturing Practice for GxP Systems)
- ISO/IEC 27017 (Cloud Security)
Medical Device
- 21 CFR Part 820
- ISO 13485
- ISO 14971
Pharma & Biotech
- 21 CFR Part 210
- 21 CFR Part 211
- cGMP, cGDP, GCP