QMS

SimplerQMS is a cloud-based electronic Quality Management System (eQMS) designed for Life Science companies, including pharmaceutical, medical device, CRO, CMO, CDMO, and medical laboratory organisations. The platform supports quality management processes such as document control, change management, training management, non-conformance and deviation management, CAPA management, supplier management, audit management, complaint management, risk management, and equipment management, all within a single integrated system.

The system is fully validated according to ISPE GAMP5 and is pre-configured with Life Science regulatory requirements in mind. It supports compliance with GxP guidelines, ICH guidelines, ISO 13485:2016, FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU GMP Annex 11, EU MDR, and IVDR. SimplerQMS is used by over 5,000 quality professionals and is developed by a team with more than 30 years of life science experience.

Core QMS Modules

• Document Control: Centralises documents and records with version control, electronic signatures, access level management, and audit trails. Supports keyword search within document titles and content for retrieval.
• Change Management: Covers all steps of change control, including creating change request documents from templates, routing for review and approval, assigning tasks, applying electronic signatures, and recording all steps in a time-stamped audit trail. Supports periodic effectiveness reviews via reminders.
• Training Management: Enables creation of detailed training plans assigned to specific employee roles. Tracks training progress, generates completion reports, sends automatic notifications for upcoming due dates or retraining needs, and maintains documented training records.
• Quiz Assessments: Supports evaluation of training effectiveness through customisable multiple-choice quizzes with pre-defined passing criteria. Quizzes follow a draft, review, and approve workflow before being linked to learning documents.
• Non-Conformance and Deviation Management: Supports registration of quality events, role assignment, routing for review and approval, and status tracking via customisable views. Data can be exported for trend analysis.
• CAPA Management: Allows escalation from deviations, non-conformances, complaints, or audit findings. Supports creation of CAPA documents from templates, multiple CAPAs per issue, effectiveness checks via reminders, and trend analysis through data export.
• Complaint Management: Captures complaint information, routes to relevant personnel for investigation, assigns tasks with deadlines, monitors status through customisable views, and supports escalation to the CAPA process.
• Audit Management: Links individual audits to audit plans and tracks scheduled regulatory inspections, supplier audits, and internal audits. Supports document retrieval during audits, assignment of responsible persons for findings, escalation to CAPAs, and traceability through linked documents.
• Supplier Management: Manages Approved Supplier Lists, contracts, certificates, surveys, evaluations, and supplier audits within a single system. Supports qualification, selection, monitoring, requalification scheduling, and collaboration with external third parties through defined access levels.
• Risk Management: Supports identification, assessment, and documentation of risks to support mitigation and compliance.
• Equipment Management: Tracks and maintains equipment records to support accuracy, availability, and regulatory compliance.

Document and Template Management

• Provides a complimentary template package based on Life Science requirements, including templates for SOPs, work instructions, non-conformance reports, CAPA forms, and audit reports.
• Templates can be customised, migrated from existing sources, or created from scratch.
• Documents are created and edited within Microsoft Office applications including Word, Excel, and PowerPoint.
• All procedures, document templates, and forms are managed across quality processes within the same system.

Microsoft Office Integration

• Integrates with Microsoft Word, Excel, PowerPoint, and Outlook.
• Documents can be edited and saved directly to the SimplerQMS cloud without manual downloading or uploading.

Automated Notifications and Audit Trail

• Supports definition of timelines when creating assignments, with automatic reminders and notifications before due dates.
• Automatically records all actions in a time-stamped audit trail.
• Sends automatic reminders for supplier certificate expiration dates and automatic email notifications for employee retraining when documents are updated.

Validation and Compliance

• Fully validated according to ISPE GAMP5 guidelines.
• Re-validated upon each new version release or standard update, reducing the time and cost burden of validation for customers.
• Conforms to FDA 21 CFR Part 11 and EU GMP Annex 11 requirements for electronic signatures, electronic records, and computerised systems.
• SimplerQMS provides assistance during customer audits or inspections and can address questions related to the eQMS.

Pricing and Subscription

• Available as an all-inclusive annual subscription with flexible licence options based on role and usage level.
• Subscription covers QMS modules, full system implementation, unlimited user training, system validation, hosting, QMS templates, and 24/7 support with no additional fees.

SimplerQMS is a cloud-hosted platform suitable for Life Science companies across pharmaceutical, medical device, biotechnology, CRO, CMO, CDMO, and medical laboratory sectors. The system is designed to support inspection readiness, cross-functional traceability, and compliance with a broad range of international regulatory standards.