Matrix Requirements
Streamline every stage of the development lifecycle with a flexible solution built for SxMD. Efficiently manage design controls from requirements to compliance with end-to-end traceability to mitigate risk.
Innovate faster with a flexible item-based approach to documentation designed to meet even the most complex SxMD product needs.
Enhance quality management with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams.
Take charge of evolving design, quality, and regulatory requirements while empowering team autonomy and get your product on the front line faster.
Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more. Leverage our REST API to connect with all your tools.
Learn more
Lockbox LIMS
A cloud LIMS that tracks samples, tests results, and manages inventory for life science research, industrial QC labs, and biotech/NGS. Includes regulatory support for CLIA and HIPAA, Part 11 and ISO 17025. The quality, security, traceability, and traceability for samples is crucial to a lab's success. Laboratory professionals can use the Lockbox LIMS system to manage their samples. They have full visibility of every step of the sample's journey from accession to long-term storage. LIMS analysis is more than just tracking results. Lockbox's multilayered sample storage and location management functionality lets you define your lab's storage structure using a variety location options: rooms and storage units, shelves and racks, boxes and boxes.
Learn more
QT9 QMS
Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals.
QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations.
Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included.
Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com
Learn more
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS 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, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
Learn more
