QMS (Quality Management System)

Purpose

The QMS feature in Lab Symplified is used to track and document quality-related tasks for inventory items before they are approved for use. It helps labs ensure required quality checks are completed, provides visual indicators for pending tasks, and maintains documentation for compliance and audit readiness.

The QMS feature supports tracking for:

• QC (Quality Control)
• Lot Correlation
• Certificate of Analysis (COA)

These tasks can be configured for items in Data Management

Data Management - Item Setup and Configuration

How QMS Works

Visual Indicator for Pending Tasks

• When a new lot is checked in for an item with QMS requirements, a red Q symbol appears next to the lot number.
• This indicates that one or more QMS tasks are pending.
• Hovering over the Q symbol displays the specific tasks that need to be completed (QC, Lot Correlation, COA).

This provides a quick visual reminder for staff and managers that the lot is not yet fully verified for use.

Definitions

QC (Quality Control)
A process used to verify the accuracy and precision of testing systems using control materials before patient or production use.

Lot Correlation
A comparison of results between a new lot and an existing lot to ensure consistency and acceptable performance prior to use.

COA (Certificate of Analysis)
A manufacturer-issued document confirming the specifications, quality, and test results of a product lot.

QMS Status Indicators

QMS status is represented by a “Q” symbol displayed next to the lot number in the Inventory table.

• Green “Q” – All configured QA activities for the lot have been completed (and reviewed, if required)
• Orange “Q” – QA activities are completed, but QC review is pending
• Red “Q” – One or more QA activities are pending or incomplete

Hovering over the Q icon displays details about which QA activities are pending or completed.

Note:
All configured QA activities must be completed and QC review finalized (if applicable) before the QMS status turns green.

In the Inventory table, you can view the status of the QMS by hovering over the Q symbol. If the QA activities are pending, the status will be reflected in red color with (pending).

When the QA activities are completed, the status will change to green and completed. All configured QA activities has to be completed and the QC (if applicable) review has to be completed before the symbol "Q" changes to green.

Procedure

Accessing QMS Activities

Users can access QMS activities in two ways:

From the QMS menu

• Navigate to the QMS from the side bar navigation menu.
• View and manage pending QC, Lot Correlation, and COA tasks across items.

From the Inventory Table (Item-Level Access)

• In the main Inventory table, locate the item or lot.
• Click the Options menu (three dots) on the right-hand side of the item.
• Select QMS.
• The system redirects directly to the QMS section for that specific item or lot.

This allows users to initiate or review QA activities directly from the inventory workflow

Performing QMS Activities

For Quality Control (QC) and Lot-to-Lot Correlation activities, users may document completion using one or both of the following methods, based on laboratory policy or workflow preference:

• Pre-built Forms
  Use the structured, built-in worksheets provided within Lab Symplified to enter results directly into the system.
• Document Uploads
  Upload supporting documentation (e.g., QC reports, correlation studies, validation records) as evidence that the QA activity has been performed.

Using Document Uploads Only

• If the user chooses not to use the available pre-built form:
  • Click the Delete button located on the right-hand side of the input field column to remove the form fields.
  • Upload the required supporting documents using the Choose File option.
• Uploaded documents are stored as part of the item or lot’s quality record and remain available for review and audit purposes.

Quality Control (QC)

• For items with pending QC, click the Options menu (three dots) and select Add QC.
• Complete the QC using:
  • A pre-built QC worksheet, and/or
  • Uploaded supporting documentation.
• Click Save.
• The QC entry is routed to QC Records.

QC Review

• In QC Records, review status is displayed.
• If review status shows NO:
  • Click the Options menu → View Details
  • Review the submitted data
  • (Optional) Upload additional files and add comments
  • Click Mark as Reviewed and Save

Once reviewed, the QC activity is marked complete.

Lot-to-Lot Correlation

• For items with pending Lot Correlation, click the Options menu (three dots) and select Correlation.
• Complete the correlation using:
  • A pre-built correlation form, and/or
  • Uploaded documentation.
• Click Save.
• The entry is routed to Lot Correlation Records.

Review (Optional)

• Review status is visible in Lot Correlation Records.
• If review is required:
  • Open View Details
  • Mark as reviewed and save

Note:
For items requiring lot correlation, The QMS icon turns green once the correlation data is entered and saved.

Certificate of Analysis (COA)

• For items with pending COA, click the Options menu and select Add COA.
• Upload the COA document.
• Click Save.
• The COA is routed to COA Records.

Note:
The QMS icon turns green once the COA is uploaded.