Best Quality Management Systems (QMS) - Page 11

Carizma QM

Carizma QM is a web-based, validated software for the creation and management of regulated documents and for CAPA management.

CAR Tool

CASQ-it

CASQ-it is a synonym for systematic defect prevention – prevention that starts in the early development process. Right from the initial product design phase, our CASQ-it modules support your project management processes, risk assessment and process planning activities and your gage management right through to the production process and product approval stages.

CauseFix

CauseFix is an AI-powered root cause analysis (RCA) platform for quality, operations and safety teams in regulated and high-reliability industries, including manufacturing, pharmaceuticals, medical devices, aerospace, food & beverage, and energy. It guides investigators through structured RCA methodologies, including 5-Why and fishbone, and uses AI to surface contributing factors, suggest corrective actions, and build institutional knowledge from past incidents. Teams use CauseFix to close investigations faster, write better CAPA documentation, and prevent recurring failures. Built on SOC 2 Type II certified infrastructure.

CERTI: AI-Native QMS

CERTI is an AI-Native Quality Management System (QMS) for manufacturers, that transforms quality management from a reactive chore into a proactive, continuously improving process. CERTI continuously monitors compliance, flags risks early & ensures every site is always audit-ready.

Certi Technologies Ltd

Certi is job management software built for UK tradespeople. Digital contracts, SHA-256 compliance certificates, automated invoice chasing with 7-stage payment escalation built to the Late Payment of Commercial Debts Act 1998. No per-seat pricing.

Change Control Software

CIKLab

CIKLab is a comprehensive quality control, lab testing, and compliance management platform specifically designed for nutraceutical, food, ingredient, and cosmetic manufacturers. It centralizes all aspects of quality management in a single digital hub, including the design and execution of quality control plans, internal and third-party lab testing, automated certificate of analysis (COA) generation, and specification sheet creation. By eliminating spreadsheets and manual processes, CIKLab reduces errors, improves traceability, and provides full visibility across the entire supply chain. The ingredient and nutraceutical industry is particularly demanding: companies must manage a wide variety of tests, including the detection of chemical and microbiological contaminants, as well as the verification of raw material and botanical active ingredient authenticity. Testing schedules are varied, and control plans and specifications can be complex and extensive. CIKLab is specifically built to handle these challenges, enabling teams to track and automate complex workflows, ensure regulatory compliance, and guarantee the safety and quality of finished products. CIKLab empowers quality managers and laboratory teams to streamline workflows, enforce standard operating procedures (SOPs), and monitor test results and batch performance in real time. By centralizing data and leveraging automation, organizations can make faster, data-driven decisions, reduce risks, and improve operational efficiency. What sets CIKLab apart from other quality management solutions is its industry-specific focus and ability to manage the complexity of control plans and specifications in the ingredients and nutraceutical sector. The platform is scalable, supports both English and French, and comes with dedicated onboarding and support to help teams implement workflows and maximize the platform’s value. By combining workflow automation, traceability, and compliance in a single solution, CIKLab helps companies maintain high quality standards and stay compliant with the most stringent regulatory requirements.

CIPA

CMX1 Platform

CodonQMS

Complere

Complere is a multi-tenant electronic Quality Management System (eQMS) built for regulated industries, including pharmaceuticals, biotechnology, medical devices, and healthcare. Quality and compliance teams use Complere to centralize document control, audits, CAPA, controlled change, risk assessments, training, and event or deviation management in one secure SaaS platform. Complere is designed as a true multi-tenant cloud platform. Each customer tenant has isolated database, storage, cache, and queue resources, with tenant separation enforced across the application architecture, helping regulated teams manage quality processes with stronger operational and data isolation. Complere includes production-ready capabilities across the full quality lifecycle: Document Control with lifecycle states, version history, controlled prints, and templates Audit Management for internal, supplier, and regulatory audits CAPA workflows for investigation, root cause analysis, action plans, and effectiveness checks Controlled Change with impact assessment and approval routing Risk Assessments using severity, probability, and detectability scoring LMS / Training for curriculum assignment, completion tracking, and assessments Event and Deviation Management for investigation and closure workflows Core platform services including RBAC, audit trail, electronic signature capture, and SSO Complere also extends into supplier-related quality workflows, connecting supplier audits, CAPA, and risk management within a controlled environment, while broader supplier management capabilities continue to mature as part of the platform roadmap. For regulated environments, Complere is designed to support key quality and compliance expectations. The platform is aligned with 21 CFR Part 11 and EU GMP Annex 11 controls, follows workflow patterns aligned with ISO 13485, supports ALCOA+ data integrity principles through audit trail and record controls, and uses a validation approach aligned with GAMP 5 and FDA Computer Software Assurance guidance. Complere supports enterprise authentication and access control through SAML 2.0, Azure AD / Entra ID via OAuth2/OIDC, and ADFS single sign-on, along with role-based access control, IP allow-listing, and authentication event logging across the platform. To help customers move efficiently through their own validation processes, Complere includes a validation-ready artifact set per module, including User Requirements Specifications, Functional Requirements Specifications, Risk Assessments, Configuration Specifications, Traceability Matrices, and IQ/OQ/PQ/UAT protocols. See how Complere helps regulated teams replace paper SOPs, spreadsheets, and disconnected point tools with one auditable, validation-ready quality platform.

ConSense

Intuitive and user-friendly Quality Management and Integrated Management Software (QMS and IMS). Includes: - Easlity edit and manage your processes - Integrate documents and files of all kinds - Use automated and intelligent document workflows - Automatically control and archive different versions of your documents - Compare versions and track changes - Individual homepage including task manager and reminders - Map your organizational structures and allocate roles and rights individually or to groups - Draw reports and evaluations

Critical Manufacturing MES

Critical Manufacturing MES helps manufacturers to digitalize their operations to compete effectively, and easily adapt to changes in demand, opportunity or requirements, anywhere, at any time.

Culture by STRASYS

Culture by STRASYS makes quality culture measurable, visible and actionable. Most organisations manage quality culture by assertion. Culture replaces that with evidence: structured assessments on a quarterly cycle, one Cultural Excellence Score from 0 to 100 per site, country and region, and an improvement action opened wherever a score falls below threshold. Five ways to measure EQ Mirror: bottom-up leadership assessment. Employees rate their leaders across configurable behavioural categories through a one-time link; respondents need no account. Culture Survey: quality culture perception across six dimensions and 22 key behaviours. Gemba Walk: three templates, 5S Culture, Quality Mindset and Safety Culture, each with ten checklist items scored 1 to 5, designed for a phone on the shop floor. Maturity Radar: six-dimension maturity self-assessment from Ad Hoc to Optimizing, current versus target. Lean: process time study with value-added, incidental and waste classification. Findings become work Every finding lands in one Actions hub with an owner and a deadline: Planned, In Progress, Completion Requested, Pending Approval, Completed. Nothing closes itself. Solutions Center 24 structured problem-solving methods including 5-Why, Fishbone, CAPA, A3, FMEA, Pareto, 8D, Kanban and ICH Q9 risk assessment, with an advisor that suggests the right method. Built for regulated work Six-level role-based access from CEO to Manager, from global down to a single site. Immutable audit trail. Quarterly cycles freeze a comparable snapshot when they close. 30-day free trial for up to 5 users, no credit card required. Runs on Android, Windows and the web with one STRASYS account; iPhone after App Store approval. English and Turkish interface. Data is isolated per organisation and stored in the European Union, with AES-256 encryption at rest and TLS 1.3 in transit. Export your data or delete your account from inside the app. GDPR, KVKK and PDPA aligned.