Dot Compliance

ABOUT :

ABOUT & FEATURES - DOT COMPLIANCE

Dot Compliance is a ready-to-use quality management system that is designed for emerging Life Science companies such as Pharmaceutical, Biotechnological, Medical Device & Cannabis manufacturers. An extensive set of off-the-shelf ready eQMS and compliance solutions, including: Document management, Complaints, Risk Management, Audits, Training, CAPA, Supplier Quality, and more are included in the software. The software is compliant with EU-Annex 11, 21 CFR part 11 and support ISO 9001, 13485, 14971 and 27001. It is a re-configured and pre-validated system based on best practice processes. Sample SOPs and KPIs are provided. Ready-to-use modules such as QMS, DMS, Audits, EBR, SQM, RA, CTMS, Maintenance, and more are also provided. Advanced data migration capabilities can be leveraged with minimal set up required for deployment. Archiving & Retention, Audit Management, Change Management, Collaboration Tools, Complaint Management, Compliance Management, Compliance Tracking, Controls Audit ,Corrective and Preventive Actions (CAPA), Defect Tracking, Document Classification, Document Coding & Control, Document Generation, Electronic Signature and Equipment Management are some of the features that can be included in Dot Compliance.