Powerful, Easy-to-Use, Lightning-Fast
Quality Management Software | QMS Software
Simplify every aspect of quality management including Document Control, Training Management, and Issues Management. Author documents with version control and approval routing. Manage access control and training records. Handle NCRs, CAPAs, SCARs, Complaints, and Audit Findings.
Ensure all regulatory and customer requirements are met, maintain up-to-date documents and training, and effortlessly ace QMS audits with a deeply-integrated quality management solution.
AUTOMATE COMPLIANCE. GET CERTIFIED FASTER. ACE YOUR AUDITS.
ACE YOUR AUDITS
"Both our AS9100 and ISO13485 auditors were extremely impressed with 1Factory's ease of use."
"I would 100% recommend the transition to 1Factory's Quality Management Software. It has helped Fairview go completely paperless over the past 3 years while helping us maintain exceptional traceability across the board"
Harrison Moulton, Quality Manager, Fairview Machine Company
QUALITY MANAGEMENT SOFTWARE | QMS SOFTWARE FEATURES
1 Standards & Requirements
Manage all external standards (e.g. ISO 9001, AS9100, ISO 13485, TS16949), customer-specific requirements (e.g. supplier quality manual), and regulatory requirements (e.g. 21 CFR Part 820) in a single centralized quality management system. Digitize requirements and make them easy to find with 1factory's document control capabilities.
2 Procedures & Work Instructions
Author procedures and work-instructions with text and images using our document authoring features. Enjoy powerful version control, with clear change history across revisions. Establish clear links between standards (requirements), procedures, and other related documents with 1factory's digital document control system.
3 Forms & Records
Manage Forms (e.g. Document Change Order) with revision control and approvals within the 1factory QMS system. Ensure that records are generated only with the latest version of a form. Route records for approval. Easily search and retrieve records for audits.
4 Training Management
Simplify training management. Establish training plans. Easily assign and track training by role and user. Generate training for (1) initial release & new revision of a procedure, (2) new hire or role change, (3) scheduled periodic retraining, and (4) retraining as part of corrective action. Ensure training is always up-to-date and avoid audit findings with 1factory's powerful QMS Training Management capabilities.
5 Multi-Site Deployments
Effortlessly manage corporate and site-specific procedures and work instructions with 1factory's Federated (Multi-Org) QMS capabilities. Corporate documents apply to all or selected sites, while site-specific documents apply to only the specific site. Effortlessly assign and track approvals and training across all sites using 1factory's powerful Federated Quality Management Software.
6 Access Controls
Protect critical documents and organizational intellectual property - procedures, work instructions, and records - by limiting access to specific user roles with 1factory's powerful QMS access control features.
7 Approval Workflows
Route documents - procedures, work instructions, and records - for approval by role and by user using the built-in workflow engine. Notify users of required approvals and document status changes via email. Record approvals and electronic signatures for traceability and Part 11 compliance.
8 Document Change History & Version Control
Easily manage changes with powerful built-in document change history, redline view, and version control capabilities integrated into our quality management platform. Simplify document review and approval with the powerful redline view that highlights additions, deletions and edits.
9 Document Effectivity
Easily set document effectivity by date, or by training period (e.g. document is automatically effective at the end of the 15 day training period), or by percentage trained (e.g. document is effective after 95% of employees are trained). Effortlessly ensure only effective documents are available for end-user use.
10 Nonconformances (NCRs)
Easily create and manage nonconformances for manufacturing or engineering caused defects, deviations, customer returns, audit findings, safety problems etc. using our QMS Software. Auto-populate NCR details from Inspections. Assign action-items, and use automated reminders to ensure timely resolution.
11 Corrective Actions (CAPAs)
Initiate CAPAs and SCARs from NCRs using our quality management software. Setup CAPA templates to guide the user, and ensure a consistent problem-solving process. Track CAPA and SCAR progress, and use automatic reminders to ensure timely resolution. Review and approve through our quality management system.
12 Supplier Corrective Actions (SCARs)
Request Supplier Corrective Actions from suppliers using the 8D process through the 1factory Supplier Portal. Work together with suppliers to resolve problems and prevent recurrence. Ensure all 8D sections are filled-out, supplier actions are completed and effectiveness is verified prior to closing out the corrective action.
13 Complaints
Record and track product failures or deficiencies reported by field service teams and customers using our quality management system. Track reported issues from initial complaint through Investigation (Review of Device /Lot History Record, Failure Analysis), Risk Assessment, Containment, Corrective Action, and Preventive Action. Assign and track actions within the QMS Software platform.
14 Audit Findings
Manage audit findings and associated tasks with 1factory's Quality Management Software. Support a continuous improvement culture by enabling team-members to log and track business process improvement actions. Ensure compliance and readiness for customer or regulatory audits.
15 Quality Matrix / Dashboard
Get a birds-eye view of your QMS and audit-readiness with the Quality Management Dashboard. View a hierarchical view of Standards, Requirements and associated Procedures. Simplify audit-prep by ensuring all documents up-to-date and all required training is complete.
16 QMS Analytics & Reporting
Easily pareto nonconformances, CAPAs, SCARs and Complaints by part number, type, supplier, detected at, caused by and other fields using our QMS Software analytics. Deliver CAPAs and Suppliers electronically within 1factory to connected Customers and Suppliers or email CAPAs and SCARs to customers and suppliers.
17 QMS Deployment and Go-Live
1factory has the fastest QMS Software deployment time on the market. With 1factory's powerful onboarding tools, you can go-live within a week. In comparison, other Quality Management Software systems will take months or even years to deploy.
CASE STUDIES
Fairview Machine - Aerospace, Medical Devices
Fairview Machine is a manufacturer or high precision Aerospace and Medical components. Fairview Machine recently deployed the 1factory quality control system and digitized their quality management processes.
Harrison Moulton, Quality Manager at Fairview Machine Company, says:
"I would 100% recommend the transition to 1Factory's Quality Management Software. It has helped Fairview go completely paperless over the past 3 years while helping us maintain exceptional traceability across the board."
Read the full case-study to learn how Fairview Machine transitioned the entire organization from a paper-based quality system to a paperless quality management solution.
EASY TO USE. LIGHTNING FAST.
INTUITIVE DESIGN
1factory's quality management software is designed for the front-line of quality with design inputs and requirements from thousands of end users. 1factory's intuitive navigation and best-in-class screen-designs make training a breeze. Training and full-deployment takes under two hours with no disruption to operations.
LIGHTNING FAST SPEED
1factory's software for quality management is engineered to be lightning-fast. We serve customers all over the world 24 hours a day, 7 seven days a week, 365 days a year. Our customers in United States, Mexico, Canada, Israel, China, South Africa, Denmark, UK, India, Malaysia, Taiwan all enjoy lightning-fast data collection and powerful real-time analytics.
SECURE AND RELIABLE
SECURITY
1factory's quality management software is hosted on AWS GovCloud. The AWS GovCloud service is an isolated Amazon region designed to host sensitive data and regulated workloads, including International Traffic in Arms Regulations (ITAR) data.
All customer data transfer from client to server is encrypted over standard HTTPS/TLS 1.2, using a certificate with 2048-bit RSA public key / SHA-256 with RSA encryption. All customer data is encrypted at rest. Data (e.g. Part Numbers, Measurements etc.) are stored in an encrypted Amazon RDS instance. Drawings, Raw Material Certificates etc. are stored on encrypted Elastic Block Storage (EBS) volumes. Drawings and other documents may be additionally encrypted with individual encryption keys.
1factory complies with all NIST-800-171 requirements. 1factory also maintains a SOC2 Type 2 certification, and a copy is available upon request.
RELIABILITY
1factory's software for quality management has been engineered to be highly reliable, scalable and available. Over 200 million parts have been inspected with 1factory by customers in 33 countries.
1factory has delivered an uptime of >99.99% over the last 8 years. We use a third-party service to monitor system uptime, and our customers can view our uptime and availability metrics in real time.
1factory backs-up database with a daily snapshot. Files are stored on redundant hard-drives and backed up via daily snapshots.
BENEFITS: QUALITY MANAGEMENT SYSTEM
CHALLENGES IN QUALITY MANAGEMENT SYSTEMS
Quality Management Systems are challenging to set up and manage. Companies must manage a wide range of documents - procedures, work instructions, forms, records (gage calibrations, nonconformances etc.). Documentation must be maintained for business processes and for actual products, often at both corporate and site-specific levels.
Document authoring and version control in traditional approaches is time-consuming and error-prone. Without proper quality management systems in place, organizations struggle to track changes, maintain revision history, and ensure only current versions are in use.
Document review and approval processes are complex and difficult to manage. Tracking multiple approvers, managing feedback, and comparing document versions manually leads to delays and confusion in workflows.
As document repositories grow, finding specific procedures, work instructions, or records becomes increasingly difficult. Organizations struggle to maintain proper access controls while ensuring employees can quickly access the documents they need.
Training management becomes overwhelming as organizations try to track requirements across roles, new hires, and document revisions. Manual tracking of training completions and due dates leads to compliance gaps and missed deadlines.
Maintaining audit readiness is a constant challenge. Quality teams spend excessive time verifying document updates, confirming training completion, and ensuring compliance with standards and requirements.
Larger organizations with multi-site operations face additional complexity in document management. Organizations struggle to maintain consistency between corporate-wide procedures while managing site-specific requirements and ensuring proper document distribution.
Without a unified quality management system linking requirements to procedures, organizations lack visibility into their effectiveness. Quality managers struggle to track document status, training compliance, and audit preparedness across the organization.
THE 1FACTORY QUALITY MANAGEMENT SOLUTION
1factory's Quality Management Software (QMS Software) simplifies all aspects of these processes, including document control, training management, issues management and more.
Authoring, Version Control, Approval: 1factory's document control capabilities make it easy to author and version-control documents. Documents can be routed for approvals by all required roles and users. And powerful red-line capability makes it easy to review changes across versions within the QMS Software.
Organization, Access and Search: 1factory's Quality Management Software organizes all QMS documents - procedures, work instructions, forms and records - with the correct context, making them easy to find, use and maintain. Access can be restricted to only the required roles. Powerful search instantly retrieves documents and records from the system.
Issue Resolution & Prevention: 1factory's QMS Software provides comprehensive tools for managing quality issues across the organization. Customer complaints can be tracked from initial report through investigation, risk assessment, and resolution using our platform.
Training Management: 1factory's Training Management capabilities make it easy to assign training and track completion by role and by user. Training can be assigned at initial release or revision of a document, or when users are hired, change roles, and require retraining through our system.
Corporate and Site Documents: 1factory's powerful multi-org capability makes it easy to manage both corporate-wide and site-specific procedures and work instructions, while ensuring employees are always working to the correct procedure in our QMS Software.
Onboarding and Migration: 1factory's built-in data import tools simplify migration of documents - text and images - from legacy systems and Word documents.
Audit Readiness: 1factory's built-in QMS Dashboard helps ensure that requirements are covered, users are trained and working to the latest version of documents. With 1factory, the system is always up-to-date and users are always prepared for an audit.
FREQUENTLY ASKED QUESTIONS (FAQ)
What industry standards and regulations does the 1factory QMS help manufacturers comply with?
1factory's Quality Management solution supports compliance with key industry standards including ISO 9001, AS9100 (aerospace), ISO 13485 (medical devices), TS16949 (automotive), and many more. We also address regulatory requirements, and offer a separate environment for manufacturers with software validation requirements (21 CFR Part 820 compliance).
With 1factory, you can centrally manage all standards, regulatory requirements, and customer requirements, link them to your procedures and work instructions, and track training, approvals, and effectiveness from one place. Every change is version-controlled with redlines, effectivity dates, access controls, and routed approvals; electronic signatures are captured for traceability and Part 11 needs. The result is a continuously audit-ready system with full traceability to see who changed what, when, and why.
Does the 1factory QMS support electronic signatures and audit trails for 21 CFR Part 11 compliance?
Yes. 1factory's QMS software includes built-in e-signatures and complete audit trails designed for 21 CFR Part 11 compliance. When e-signatures are enabled, each signing event captures the signer's name, digital signature, date/time, and the meaning of the signature (for example, releasing an inspection plan or accepting a lot).
Signatures are executed with a unique username and password, and the system maintains a durable audit trail to safeguard integrity and traceability, capabilities that help regulated manufacturers satisfy electronic records and signature requirements.
Records and forms follow the same controls, making it easy to route for approval and retrieve evidence during audits. Training assignments and completions are also tracked automatically, further tightening your compliance posture for multi-site deployments.
Does the 1factory Quality Management System support Supplier Quality Management (SCARs, scorecards, audits etc.)?
Yes. 1factory offers a full supplier quality module so you can collaborate with suppliers to identify and resolve issues early, and ensure the quality of parts before they leave your suppliers' factories.
1factory's supplier quality management module delivers automated supplier scorecards and dashboards fed by real-time supplier inspection data (measurements recorded at the supplier) and incoming-quality data (recorded at receiving inspection).
Does 1factory support Advanced Product Quality Planning (APQP), PPAP, and FAI processes?
Yes. 1factory's manufacturing quality control module provides built-in capabilities to support the New Product Introduction process, including FAI, PPAP, Control Plans, PFMEAs, Process Flows, Gage R&Rs, Measurement Data, Process Capability Analysis and more.
What industries does 1factory support? Can the QMS support multi-site or global operations with shared documents?
The 1factory QMS supports manufacturers across a wide range of industries such as Aerospace, Defence, Medical Devices, Industrial Equipment, Injection Molding, Machining, Sheet Metal Fabrication, Flow Control, Gear Manufacturing, Firearm Manufacturing and many more.
1factory is the only QMS product on the market with powerful Federated (Multi-Org) QMS capabilities which allow manufacturers to effortlessly manage corporate-wide and site-specific documents (procedures and work-instructions), as well as documents that may be shared across some or all sites.
How long does it take to deploy and go live with 1factory's QMS?
1factory offers the fastest QMS Software deployment time on the market. With our powerful onboarding and data import tools, you can go-live within weeks, compared to months or years with other systems.
How is the 1factory QMS system priced? Do you offer a 'read-only' license type for authors, collaborators, or part-time users?
The 1factory QMS is priced on a simple per-named-user basis (regardless of role), allowing you to assign seats and roles to best support your business.
While other software providers may offer a concurrent-user pricing model, or a tiered-pricing model with different pricing for document authors vs read-only users, at 1factory, we believe in keeping things simple.
With 1factory's simple pricing model, you can easily move people between roles with no impact to overall cost, and enjoy pricing that is 60% to 80% lower than our competitors' pricing.
Please see detailed pricing here.
Are implementation, system validation, and support included in the licensing cost?
Yes. Our per-user subscription pricing includes onboarding and training, data backups, product enhancements, validation test cases, and ongoing support for our QMS software.
There are NO hidden costs with 1factory.
500+ CUSTOMERS. 30+ COUNTRIES. 20+ INDUSTRIES.
AEROSPACE & DEFENSE
AEROSPACE MACHINING
PRECISION MACHINING
MEDICAL DEVICES
AUTONOMOUS AIRCRAFT
ADVANCED CERAMICS