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Optimize document processes
Our 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.
Easily meet industry requirements
ISO 9001
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.
EU MDR
FDA 21 CFR
PART 820
FDA 21
CFR PART 11
GAMP 5
EU
ANNEX 11
MD SAP
ISO 27001
ISO 14971
Drive cross-organizational quality processes
A simplified, faster, and with greater precision, DOT Compliance Suite puts organizations in control of their compliance status.
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.
KPIs and adherence reports for metrics and tracking of document management processes.
Connect DMS with QMS
Integrate all the quality processes you need by leveraging the power of seamless integration with Dot Compliance Suite QMS - training, change control, Registration Management, Clinical Trials and other quality processes.