CAPA actions tracked in spreadsheets with no systematic follow-up or closure verification?
Document control done by emailing PDFs with version numbers in the filename?
Audit findings managed in a shared folder with no visibility on open versus closed items?
Calibration overdue alerts sent by someone who checks a spreadsheet once a week?
Quality Management System Software Development
When CAPA actions live in spreadsheets and document versions travel by email, your quality system is only as reliable as the last person who remembered to update the file. An audit response that should take minutes takes a day because the records are spread across folders and inboxes.
We build custom QMS software for manufacturers who need structured, auditable quality processes. From CAPA and document control through supplier quality and SPC, we build systems that hold up under an auditor's scrutiny and give quality teams visibility they can act on.
CAPA management with root cause, action assignment, effectiveness verification, and closure workflows
Document control with version management, approval workflows, and controlled distribution
Audit management for internal, supplier, and customer audits with finding and corrective action tracking
SPC charts and process monitoring with out-of-control alerts for key quality characteristics
A Quality Management System (QMS) is the software layer that manages non-conformances, corrective actions, document versions, audits, and supplier quality in a controlled, auditable way. It replaces spreadsheet-based CAPA tracking and emailed PDFs with structured workflows and a single source of truth. RaftLabs builds custom QMS software aligned to ISO 9001, IATF 16949, and FDA 21 CFR Part 11 requirements.
Generic QMS platforms are built to cover every industry with a single configuration. The result is a system with screens and fields your team will never use sitting next to gaps that require workarounds for your specific process. Customisation options are limited by what the vendor has exposed, and you pay per user for features you don't use.
A custom QMS is built around your quality processes, your document hierarchy, your audit schedule, and your non-conformance categories. It fits the way your quality team actually works, which means adoption is faster and the data quality is higher. When an auditor arrives, you can pull the records they need in minutes rather than spending the morning reconstructing them.
We build QMS software for manufacturers operating under ISO 9001, IATF 16949, AS9100, and FDA quality regulations. We design the data model and audit trail to meet the evidentiary requirements of your certification standard before development starts.
What we build
CAPA and non-conformance management
Non-conformances are captured at the point of detection, whether on the production line, in incoming inspection, or from a customer complaint. Each NCR triggers a structured workflow: containment, root cause analysis using 8D or Ishikawa, corrective action definition, action assignment with due dates, and effectiveness verification before closure. Nothing falls through the cracks because the system drives the workflow and escalates overdue items automatically.
Document control and approval workflows
Documents are created, reviewed, and approved inside the system. Version history is maintained automatically. When a document is revised, the previous version is superseded and archived with full traceability. Controlled copies are distributed electronically with read confirmation. No more emailed PDFs with version numbers in filenames. Audit requests for a specific document version at a specific date are answered in seconds from the version history log.
Audit management
Plan and schedule internal audits, supplier audits, and customer audits from a single audit calendar. Audit plans are linked to scope, checklist, and assigned auditors. Findings are recorded during the audit with severity classification. Each finding generates a corrective action that flows into the CAPA module. Open findings, closure rates, and repeat findings are visible in audit performance dashboards so the quality manager knows where attention is needed without asking for status updates.
Supplier quality management
Maintain an approved vendor list with supplier classification, approval status, and performance scores. Record incoming inspection results by supplier and part number. Track supplier corrective action requests (SCARs) with the same structured workflow as internal CAPAs. Supplier performance dashboards show defect rate, on-time delivery, and SCAR response time so supplier reviews are grounded in data rather than anecdote.
Calibration management
Register every gauge, instrument, and measuring device with calibration interval, responsible owner, and calibration procedure. The system generates calibration due notices automatically and escalates overdue items before they affect production. Calibration records store the results, the reference standard used, and the technician who performed the calibration. If an instrument is found out of tolerance, the system flags all measurements taken since the last valid calibration for review.
Statistical process control
Define control charts for key process characteristics and enter measurement data at the point of production or import it directly from measurement systems. The system plots Xbar-R, Xbar-S, and individuals charts and applies Western Electric rules to flag out-of-control conditions in real time. Cp and Cpk indices are calculated automatically. Process capability reports are generated for customer PPAP submissions or internal review without manual charting in spreadsheets.
Frequently asked questions
Yes. We map the system modules to your certification clauses during the requirements phase so that the QMS supports your management system rather than working against it. The audit trail, record retention settings, and document control workflows are designed to satisfy the evidentiary requirements of your standard. We have built QMS systems used in successful ISO 9001 and IATF 16949 surveillance audits and can reference similar projects during scoping.
For FDA-regulated manufacturers, we build electronic signature and audit trail functionality that meets 21 CFR Part 11 requirements. This includes time-stamped audit trails that cannot be modified, individual user authentication for approvals, and electronic signature attribution. We document the Part 11 assessment for your validation package. The validation approach and documentation structure are agreed before development starts so the IQ/OQ/PQ process is straightforward.
Yes. Common integration points include pulling non-conformance data from an MES when a quality hold is placed on a work order, syncing supplier and part master data from the ERP, and pushing inventory hold flags back to the ERP when material is placed on quality hold. Integration method depends on your ERP's API capabilities. We assess the integration requirements during scoping and build the connectors as part of the project.
A QMS covering CAPA, document control, and audit management typically takes 14 to 18 weeks from requirements sign-off to go-live. Adding supplier quality and calibration management extends this by four to six weeks depending on the volume of existing data to migrate. We stage the rollout by module so your team can start using the system incrementally rather than waiting for everything to be complete before going live.
Tell us about your quality processes and the certification standards you operate under. We'll scope a system that works for your auditors and your team.
