Almond QMS

Almond QMS is a cloud-based electronic Quality Management System (eQMS) developed by Gsap, designed specifically for healthcare companies including medical device, pharmaceutical, biotech, and life sciences organisations. It is built to support regulatory compliance and quality process management across the full product lifecycle, with an emphasis on ease of use and straightforward implementation.

The system is modular and flexible, allowing organisations to configure their own quality processes and work environments. It supports an unlimited number of users and is accessible remotely, making it suitable for teams operating across multiple locations or countries.

Core Modules and Capabilities

• Documents control
• Trainings management
• Smart E-forms and Processes Generator for building custom electronic forms and workflows
• Logbooks
• CAPA (Corrective and Preventive Actions) management
• Change Control
• Non Conformance and Deviations tracking
• Audits management
• Surveys
• Gantt Chart for project and task planning
• Suppliers management and qualification
• Instruments management and calibrations
• Product management tool

System Characteristics

• Cloud-based architecture supporting continuous remote access for an unlimited number of users
• Flexible and modular design allowing customers to tailor their work environment and build customised quality processes
• Described by users as simple to implement, with short onboarding and training periods
• Supports multi-site and international team collaboration, as noted by customers with both Israeli and US-based teams

Regulatory Compliance

• 21 CFR Part 11 (electronic records and signatures)
• ISO 13485:2016 (quality management systems for medical devices)
• 21 CFR Part 820 (quality system regulation for medical devices)

Background and Ecosystem

• Developed by Gsap, an international consulting firm providing end-to-end services for healthcare companies across the medical product lifecycle
• Associated with SE Pharma, which provides validation and calibration services for pharmaceuticals and medical devices
• Connected to a training and learning centre serving pharma, advanced therapies, medical devices, and medical cannabis industries

Almond QMS is offered as a standalone software product with a demo and free trial available. It is positioned for healthcare companies seeking a structured, compliance-ready QMS that can be implemented and managed without extensive technical overhead.