Embryonic Stem Cells

DOT COMPLIANCE PRESENT

Common use cases for cell therapy companies

Dot Compliance's quality-driven solutions are designed to support cell therapy companies with all core QMS business processes and many more.

Controlled Document Management of SOP’s, Work instructions and protocols

Employee and 3rd party stakeholder training management and training

Equipment maintenance, equipment cleaning procedures and calibration

Change control for documentation, processes, products

Portal availability for 3rd party stakeholders and suppliers engagement

COMPLIANT WITH

FDA 21
CFR PART 11
EU
ANNEX 11
ISO 9001
FDA 21 CFR
PART 820
GAMP 5
EU MDR
MD SAP
ISO 27001
ISO 14971
TRUSTED BY LIFE SCIENCES

Who we are?

Dot Compliance is a purpose-built, electronic Quality Management System (eQMS) suite that ensures the quality of manufactured human drug and biologic products as well as the proper design, control, and monitoring of manufacturing processes and facilities. 


Our wide range of quality processes enables cell therapy organizations to instantly digitize, streamline, and control their quality operations from end to end.