Compare BPAQuality365 vs. ISO 13485 Quality Management

isoTracker Quality Management is a popular cloud-based quality management software (QMS) system. It is used on a worldwide basis by businesses to manage their ISO 9001, ISO 13485, ISO 22000, ISO 17025, ISO 14001 systems...plus many others. It is a modular product which can be configured to meet an organization's specific requirements and is competatively priced with superg customer support. Any module combination of Document Control, Complaints, CAPA, Audits, Training, Non-Conformance and Risk can be subscribed to.

The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance: 1) SBS Quality Database - CAPA / 8D corrective and preventive actions (CAR) with root cause analysis - Nonconformance management - Risk analysis including FMEA, SWOT, interested party risk register - Internal, customer, and third-party audit management - Environmental Health and Safety (EHS / HSE) management 2) SBS Ground Control - Employee training management (LMS) - Self-Paced training - Change control - Document control 3) SBS Asset Tracking Database - Calibrated equipment control - Preventive maintenance - Asset inventory management 4) SBS Inspection Database - Record incoming material, in process, and final product inspection data - Generate real time SPC charts - Inspection plans and Control Plans - Archive data for further statistical analysis 5) SBS Vendor Management - Maintain an approved vendor list or AVL - Develop vendor / supplier qualification plans - Maintain vendor / supplier qualification history Modules may be purchased separately or in any combination. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.

Intelex delivers a unified software system for overseeing Environmental, Health, Safety, and Quality (EHSQ) initiatives. Its expandable platform is crafted to consolidate, oversee, and scrutinize EHS and Quality data comprehensively. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: Elevate your EHSQ program outcomes by supervising workflows for superior performance and command. Discern patterns and propensities through goal-setting to deepen understanding and improve decision-making in your EHSQ program. Diminish occurrences and cut down on administrative tasks by efficiently supervising, managing, refining, and extracting insights from your safety data via our intuitive safety software. Simplify the management and reporting of air, water, and waste emissions, and oversee environmental outputs to fulfill sustainability objectives. Foster ongoing improvements in quality by seamlessly logging and monitoring all instances of nonconformity within a unified, web-based system. Investigate trends across various departments, sites, or locations. Intelex can help you manage compliance with international standards and regulations such as: OSHA, WCB, ISO 45001, EPA, ISO

QBench allows you to keep track of all your samples and where they are located in the workflow using a single system. QBench eliminates the need for spreadsheets, shared folders in the network, and paper-based tracking systems. You can view hundreds of PDF reports/COAs before publishing or emailing. You can generate barcodes and create labels that you can customize for your samples. Compatible with standard printers and scanners. QBench's billing module allows you to create and send invoices right from the system. You can see counts and latencies for different data types in QBench. This includes metrics like turnaround time, sample counts per test, sample delay, and many others. QBench makes it easy for you to gather the data your lab needs for the assays you perform.

HSI Donesafe redefines EHS management with a no-code, cloud-based platform that transforms complex processes into streamlined, user-friendly workflows. Trusted across industries, Donesafe consolidates tracking, management, and reporting into one accessible platform, making compliance simpler and safety more effective. Donesafe’s adaptable design allows teams to customize workflows, forms, and dashboards to meet evolving compliance needs. With tools for incident reporting, audits, training, and risk assessment, staying ahead of regulatory changes has never been easier. Key Features: - Customizable workflows to align with regulations - Real-time insights for live safety tracking - Scalable design that grows with your team - Streamlined compliance tools for smooth audits and reporting Empower your EHS team to achieve safety excellence with HSI Donesafe.

Process Street is the Compliance Operations Platform built for teams that need to move fast without breaking standards. It combines document control, workflow automation, and AI-powered oversight in a single system so every policy is followed, every step is tracked, and every audit is effortless. Unlike legacy GRC tools or static SOP docs, Process Street turns compliance into a living system. Policies are documented in governed, version-controlled Pages. Those policies are executed through dynamic workflows with built-in task assignment, approvals, and forms. Every action is logged, monitored, and optimized in real time by Cora, our AI compliance agent. Used across industries like financial services, real estate, healthcare, and manufacturing, Process Street helps teams automate employee onboarding, streamline audits, manage policy updates, enforce vendor reviews, and run critical processes at scale. No code required. No micromanagement. Just proof that work gets done right, every time. Companies like Salesforce, Colliers, Drift, and Hartford Healthcare trust Process Street to eliminate busywork, improve operational visibility, and reduce compliance risk across the business. With native integrations, role-based access, audit trails, and ISO-aligned workflows, it is the platform that makes compliance a competitive advantage. From onboarding to audits, Process Street is how high-stakes teams enforce standards, automate execution, and prove compliance by default.

Certainty is an enterprise-level auditing and inspection software that can be trusted to help you manage and report on business risk, compliance, and performance metrics quickly and efficiently. Certainty Software is used by hundreds of thousands of professionals to complete millions of inspections and audits each year. It provides all the tools you need to collect, collate, and report consistent, accurate, and meaningful metrics across your business. Certainty provides all the tools you need to design, manage, and report on audit/inspection data, as well as help you manage and mitigate any risks, incidents, and issues that may be identified during the audit/inspection process.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

The HYPERSECURE Platform by DriveLock is designed to fortify IT systems against cyber threats. Just as securing your home is a given, protecting business-critical data and endpoints should be seamless. DriveLock’s advanced security solutions ensure full lifecycle data protection, combining state-of-the-art technology with deep industry expertise. Unlike traditional security models that rely on patching vulnerabilities, the DriveLock Zero Trust Platform proactively prevents unauthorized access. With centralized policy enforcement, only authorized users and endpoints gain access to essential data and applications—strictly adhering to the never trust, always verify principle.

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.