Results for: iso 10303 21_______
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ISO Compliance Software
ISO compliance software is software designed to help businesses ensure their operations meet the standards set by the International Organization for Standardization (ISO). This type of software typically includes features such as document management, risk assessment, and corrective action tracking to assist with achieving and maintaining compliance. It is often customizable to fit the specific needs of different industries and can be used for various ISO certifications. The software aims to streamline the process of meeting ISO requirements, saving businesses time and resources. Ultimately, it helps companies uphold high-quality standards in their processes and operations.
ISO 27001 Compliance Software
ISO 27001 compliance software is a tool designed to help organizations ensure their information security program aligns with the requirements of the ISO 27001 standard.
CAPA Software
CAPA (Corrective and Preventive Action) software helps organizations identify, manage, and resolve issues that affect product quality or compliance by tracking corrective and preventive actions. It streamlines the process of investigating root causes, implementing corrective actions, and preventing future occurrences, ensuring continuous improvement in operations. The software automates tasks like incident reporting, workflow management, and documentation, allowing for more efficient handling of quality and compliance issues. CAPA software also provides detailed reporting and audit trails to support regulatory compliance and enhance accountability. Overall, it helps businesses improve product quality, reduce risks, and maintain compliance with industry standards.
View more categories (6) for "iso 10303 21_______"
33 Products for "iso 10303 21_______"
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1
All in One Accessibility
Skynet Technologies USA LLC
...It supports GDPR, HIPAA, CCPA, SOC Type 2, ISO 9001:2005, & ISO 27001:2022.Starting Price: $25/month -
2
isoTracker Quality Management
isoTracker Solutions Ltd
isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it.Starting Price: $17 USD/month/user -
3
qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. ...">
Starting Price: $500/month/10 users -
4
IMSXpress is a sophisticated document control, regulatory compliance, and quality system management platform used for operating ISO 13485 and FDA 21 CFR part 820 quality system that include document distribution, document control, CAPA, complaints, audits, training, MDR, supplier control, NC product, and more. Available as a local install or cloud data hosting, this cutting-edge software comes pre-loaded with template manuals and procedures, employee training booklets, and audit checklists.Starting Price: $1460.00/one-time
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5
isoTracker Document Control
isoTracker Solutions Ltd
isoTracker Document Control by isoTracker Solutions is a cloud-based document control and management software that automates the control of documents that meets the requirements of ISO 9001, ISO 13485 and other similar standards. Secure and automated, isoTracker Document Control allows users to store important documents, protect them with encryption, and permits access in a controlled way. isoTracker Document Control also features an automatic archive of old documents and maintenance of a historical record of all documents. ...Starting Price: $17 USD/month/user -
6
Caliber v18
Dhruthi Technologies
...Saves time through quick look up and entry of multiple gages with minimal data entry. Reduces session time with efficient, user-friendly gage calibration software system. Ensures all quality requirements (ISO 9001; ISO13485; ISO 14001, ISO 17025, TS 16949; AS 9100; 21 CFR Part 11 and many more) are met or exceeded.Starting Price: $1000 one-time payment -
7
Interfacing Integrated Management System (IMS)
Interfacing Technologies Corporation
...Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. ...Starting Price: $10/month/user -
8
Q-Med Database
Sunday Business Systems
...Compile and analyze Customer Survey results. Document QMS review meetings and results. Cloud based or locally installed options are available. The Q-Med Database is ideal for small businesses striving for ISO 13485 compliance. CFR21 Part 11 compliant.Starting Price: $1900.00/one-time -
9
CloudLIMS
CloudLIMS
CloudLIMS.com is an ISO 9001:2015 certified informatics company. Their SaaS, in the cloud Laboratory Information Management System (LIMS), CloudLIMS, offers strong data security, complimentary technical support, instrument integration, hosting and data backups to help biorepositories, analytical, diagnostic testing and research laboratories, manage data, automate workflows, and follow regulatory compliance such as ISO/IEC 17025:2017, GLP, 21 CFR Part 11, HIPAA, ISO 20387:2018, CLIA, ISO 15189:2012, and ISBER Best Practices at zero upfront cost. ... -
10
ins2outs
ins2outs
ins2outs is a cloud-based SaaS integrated compliance management platform that empowers organizations to define, operate, and maintain multiple management systems, such as quality, information security, privacy, environment, and AI, within a single unified environment by combining powerful software, pre-built “know-how” sets mapped to standards like ISO 13485/21 CFR 820, ISO 27001, ISO 27701, IEC 62304, and ISO 42001, and expert consulting services. It helps organizations build structured documentation, including policies, processes, procedures, instructions, and document templates, and manage workflows with automated role-based training, push notifications, compliance KPIs, configurable documentation logic, version control, and audit trails, all hosted securely in the cloud. ...Starting Price: $25 per month -
11
Eupry
Eupry
...Its wireless data loggers stream real-time temperature and humidity data even during Wi-Fi outages; patented sensor tips let you recalibrate devices in under a minute without swapping loggers; and configurable mapping kits produce precise, audit-ready reports with minimal effort. Eupry runs in an ISO 17025-accredited, ISO 9001- and ISO 27001-certified environment and includes FDA 21 CFR Part 11 controls, automatic deviation alarms, digital calibration certificates, and one-click documentation features. Whether you need end-to-end oversight or wish to pick individual modules, monitoring, mapping, or calibration, the platform delivers a single source of truth for compliance data, streamlines audits, reduces manual work, and keeps you ahead of regulatory changes. -
12
Qualcy QMS
Qualcy Systems
Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.Starting Price: $799 per month -
13
CAPA Manager
Adaptive Business Management Systems
...It error-proofs the control of the entire CAPA process, from initiation to investigation and all the way through to closure. CAPA Manager meets the requirements of all important quality management standards: 21 CFR part 11, ISO 9001, AS9100, TS 16949, and more. It keeps records of root-cause and corrective action while providing pre-defined workflows and approval gates.Starting Price: $12.49 per user/month -
14
Virje
Virje
Virje complies with the requirements of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. Overwhelmed by the thought of Part 11 software validation? Accessible from wherever you are, for whenever you work. Eliminate paper, reduce cost, and increase efficiency with automation and centralized collaboration. Perfect for small to medium-sized businesses. Built from the ground up specifically for medical device quality management. -
15
TARA PV
MedGenesis
TARA PV is a comprehensive, web-based pharmacovigilance safety database designed for processing, storing, analyzing, and reporting adverse events related to drugs, devices, and vaccines. Developed by MedGenesis Ltd, an ISO 9001 and ISO 27001 accredited UK-based software development company, TARA PV offers a user-friendly interface that is simple, intuitive, and fully compliant with 21 CFR Part 11, GxP, ICH standards, and global pharmacovigilance data protection regulations. As a cloud-based solution, TARA PV requires no installation and is accessible via an internet browser, enabling rapid implementation and integrated workflows for individual case assignments. ... -
16
SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. ...Starting Price: $13,750/year -
17
CalibrationOS
Cabrillo Club
...Tracks schedules, as-found/as-left data, OOT investigations, audit-ready reports. GUM uncertainty budgets, ILAC G24 intervals, AIAG Gage R&R, hash-chained audit trail. AS9100d, iso 17025, FDA 21 CFR Part 11. Free: 25 assets forever.Starting Price: $0 -
18
WeldOffice
C-spec
C-spec's WeldOffice WPS is a comprehensive welding procedure software that automates the creation and management of Welding Procedure Specifications (WPS) and Procedure Qualification Records (PQR), ensuring compliance with the latest ASME Section IX and AWS D1.1 code requirements. The software features automatic code checking, supported by active ASME, AWS, and ISO committee members, providing users with confidence in the code compliance of their welding procedures. It includes universal forms that support multiple codes, such as ASME IX, ISO 15614, AWS B2.1, D1.1, D1.2, D1.3, D1.4, D1.5, D1.6, D9.1, and API 1104, and accommodates multiple welding processes, including SMAW, GTAW, GMAW, FCAW, SAW, PAW, ESW, EGW, and OFW, on a single document sheet. ...Starting Price: $7,500 one-time payment -
19
GxPLABS
GxPLABS
...The platform is designed to be platform-independent, low code, and AI-based, supporting flexible deployment and customization. GxPLABS solutions comply with industry standards such as 21 CFR Part 11, Annex 11, ISO 9001, and ISO 27001, ensuring regulatory alignment. With over 10 years of experience serving customers across more than 10 countries, they provide expert client support and scalable, complex technology solutions. Businesses can also develop fully customized software using their platform to meet unique needs. -
20
oomnia
Wemedoo AG
...No coding is required due to intuitive drag-and-drop features. oomnia is fully interoperable, eliminating integration issues, and offers role-based access with a user-friendly interface customizable by language and notifications. Real-time reporting, seamless randomization, and complete audit logs enhance efficiency and data accuracy. The platform complies with 21 CFR Part 11, EU Annex 11, and CDISC standards. ISO 27001 and ISO 9001 certified and FDA/Swissmedic inspected, oomnia enables up to 50% time and cost savings through streamlined, intelligent trial management. -
21
TEEXMA
BASSETTI
...As a truly global solution, TEEXMA empowers international organizations to harmonize their laboratory processes across multiple sites. It supports multi-language interfaces and ensures strict compliance with international standards such as ISO 17025, FDA 21 CFR Part 11, and GLP. By centralizing technical data and capitalizing on expert know-how, BASSETTI Group helps industry leaders in Aerospace, Energy, and Life Sciences reduce time-to-market and ensure total data traceability. TEEXMA is the ultimate tool for achieving digital continuity in a competitive global landscape. -
22
Vispato
Vispato
Vispato provides an anonymous way to communicate with stakeholders and employees – making them feel comfortable to report any concerns. With end-to-end encryption, access controls, ISO 27001 servers, and more, you can be confident that the only people with access to your data is you. Vispato is user-friendly, modern software built for the 21st century. Employees require no training or consulting to use it. Schedule a demo and have everything set up today – with no consulting upsells or lengthy sales process. Suitable for companies of all sizes and configurable to deal with any forms of anonymous misconduct reporting. ...Starting Price: €99 per month -
23
Arena QMS
Arena, a PTC Business
...Arena QMS streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena QMS ensures regulatory compliance to various quality standards and regulations, including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans. -
24
QLIMS
OnQ Software
...The platform includes in-built business intelligence dashboards, providing real-time insights into management and operational data, with pre-configured visualizations and the flexibility for users to build their own. QLIMS supports compliance with various industry standards, including 21 CFR Part 11/Annex 11 for auditing and e-signatures, ISO 17025, and GAMP, while ensuring data security and privacy in line with HIPAA, GDPR, CAP, CLIA, and Privacy Shield requirements. -
25
Confience myLIMS
Confience
...This comprehensive software solution enables labs to efficiently manage samples, automate workflows, ensure data accuracy, and maintain compliance with regulatory or industry standards such as FDA 21 CFR Part 11, TNI/NELAC, EPA, ISO 17025 or GLP/GMP guidelines. Labs can leverage Confience myLIMS to optimize their processes, from sample collection and tracking to analysis and reporting, ensuring that they meet regulatory requirements while delivering high-quality results. One of the standout benefits of Confience myLIMS is its ability to drive continuous improvement within lab environments. ... -
26
ProCal
TMA Systems
...ProCal automates calculations, applies tolerances, and instantly flags pass or fail results to minimize human error. The platform generates audit-ready records, certificates, and complete calibration histories to simplify inspections and regulatory reviews. Built for ISO, GMP, FDA, and 21 CFR Part 11 compliance, it supports secure access, electronic signatures, and approval controls. ProCal scales easily from single departments to global enterprises with multi-account and multi-language support. Trusted by leading manufacturers, it delivers a streamlined, paperless approach to calibration management. -
27
Chatwork
ChatWork
...Person-by-person status updates. Really? Still?! Imagine your daily back-to-back meetings are replaced by project-specific quick video chats. Only as needed. You know it's there. Somewhere in the 21,396 unread emails and paper piles on the desk. So what if all those buried file attachments suddenly became masterfully organized. By project or topic. In context. We store all your business data using 256-bit encryption to ensure data is protected and secure. Also we are ISO27001 certified, the most widely recognized security standards. ...Starting Price: $4 per month -
28
Qualis LIMS
Agaram Technologies
... • Record final results of tests & experiments - manage tests, projects, samples, instruments & inventory in one central secure database. • Meet data integrity & regulatory compliance requirements such as GxP, ISO17025, 21 CFR Part 11 & EudraLex Annex 11 without any compromises. -
29
Ennov Quality Suite
Ennov
...Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. ... -
30
Intellect
Intellect
Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. ...