Document Management

What is Document Control?

A Document Management System (DMS) is an electronic solution for drafting, reviewing, approving, tracking and storage of organizational documents. An efficient DMS is designed to store records of the variations and versions of a document, while also allowing easy access to the file for various users maintaining specific roles across the organization, adjustable to your needs via the DMS privacy settings.

 

Why do we need it?

Organizations subject to government regulations like FDA 21 CFR part 820 are required to work with controlled documents. Critical documents like procedures, work instructions, and policy statements are ideally controlled in a system that’s designed to meet industry requirements.

 

How does The Document Management element of Dot Compliance Help Me?

DOT Compliance Suite puts organizations in control of their compliance status, driving cross-organizational quality processes  - simplified, faster and with greater precision. Our solution offers key features to optimize document control and compliance documentation, such as:

  • Preconfigured workflows based on industry best practices. 

  • A user-friendly and step-by-step approval process with electronic signatures.

  • Full tracking of document revision history.  

  • PDF generation with watermarks, headers and signatures.  

  • Automated periodic review processes.

  • Controlled printing of documents based on user privileges.

  • Optional access to external users via a secured portal.

  • Seamless integration with training, change control and other quality processes. 

  • Integrated with our Registration Management and Clinical Trials modules.

  • KPIs and adherence reports for metrics and tracking of document management processes.