Powerful, Easy-to-Use, Lightning-Fast
Quality Management System (QMS)
Software.
Unlock the power of a digital QMS. Eliminate Paper and Word documents. Enjoy powerful change management, access controls, approval workflows and training management. Record, assign and track progress for NCRs, CAPAs, SCARs, and Complaints.
DIGITIZE YOUR QMS. AUTOMATE COMPLIANCE. ACE YOUR AUDITS.
COMPLIANCE MADE EASY
Effortlessly ensure all requirements from standards (AS9100, ISO9001, ISO13485, AS13100 etc.), regulatory bodies (FDA etc.), and customers are addressed by procedures and work instructions.
Ensure all documents are up-to-date and users are working with the latest versions. Easily assign and track training to completion.
Ensure all corrective and preventive action tasks are complete.
Ace your audits.
KEY QMS FEATURES
1 Standards & Requirements
Manage all external standards and requirements, including: standards (e.g. ISO 9001:2015), customer-specific requirements (e.g. supplier quality manual), and regulatory requirements (e.g. 21 CFR Part 800).
2 Procedures & Work Instructions
Author procedures and work-instructions with text and images directly in the 1factory QMS. Enjoy powerful version control, with clear change history across revisions. Establish clear links between procedures, requirements, and related documents.
3 Forms & Records
Manage Forms (e.g. Document Change Order) with revision control and approvals in the 1factory QMS. Ensure that records are generated only with the latest version of the form. Route records for approval. Easily search and retrieve records for audits.
4 Training Management
Establish a training plan for each procedure with a list of roles that require training. Easily assign and track training to all users with selected roles, or to selected users. 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.
5 Enterprise Deployments
Author and manage corporate and site-specific procedures and work instructions. Corporate documents apply to all or selected sites, while site-specific documents apply to only the a specific site. Effortlessly assign and track training across all sites.
6 Access Controls
Protect critical documents and organizational intellectual property - procedures, work instructions, and records - by limiting access to specific user role.
7 Approval Workflows
Route documents - procedures, work instructions, and records - for approval by role and user. Notify users of required approvals and document status changes via email. Record approvals and electronic signatures.
8 Change History & Version Control
Easily manage changes with powerful built-in document Change History, Redline View, and Version Control capabilities. Simplify document review and approval with the powerful redline view showing additions, deletions and edits.
9 Non-conformances
Easily create and manage non-conformances for manufacturing or engineering caused defects, deviations, customer returns, audit findings, safety problems etc. Autopopulate NCR details from Inspections. Assign action-items, and use automated reminders to ensure timely resolution.
10 Corrective Actions
Initiate CAPAs and SCARs from NCRs. 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.
11 Supplier Corrective Actions
Request Corrective Actions (SCARs) from suppliers using the 8D process. 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.
12 Complaints
Record and track product failures or deficiencies reported by field service teams and customers. 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
13 Audit Findings
Manage audit findings and associated tasks. Ensure compliance and readiness for customer or regulatory audits. Support a continuous improvement culture by enabling team-members to log and track business process improvement actions.
14 Quality Matrix / Dashboard
Get a birds-eye view of your QMS and audit-readiness with the QMS Dashboard. View a hierarchical view of Standards, Requirements and associated Procedures. Simplify audit-prp by ensuring all documents up-to-date and all required training is complete.
15 QMS Analytics & Reporting
Easily pareto non-conformances, CAPAs, SCARs and Complaints by part number, type, supplier, detected at, caused by and other fields. Deliver CAPAs and Suppliers electronically within 1factory to connected Customers and Suppliers or email CAPAs and SCARs to customers and suppliers.
16 QMS Deployment and Go-Live
1factory has the fastest QMS deployment time on the market. With 1factory's incredibly easy-to-use QMS platform and onboarding tools, you can go-live within a week, where other QMS systems take months or even years to deploy.
EASY TO USE. LIGHTNING FAST.
INTUITIVE DESIGN
1factory is designed for the front-line of quality control with design inputs and ideas from our 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 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 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 has been engineered to be highly reliable, scalable and available. Over 200 million parts have been inspected with 1factory by customers in 26 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.
500+ CUSTOMERS. 25+ COUNTRIES. 20+ INDUSTRIES.
AEROSPACE & DEFENSE
AEROSPACE MACHINING
PRECISION MACHINING
MEDICAL DEVICES
AUTONOMOUS AIRCRAFT
ADVANCED CERAMICS