Overview

Title21 Software’s Quality Manager is a suite of products that provides a “closed-loop” system for an integrated Quality Management System. For firms that do not require its full capabilities, modules may be purchased separately for Quality Data Management, Document Control and Training.

All of our modules are 21 CFR part 11 compliant, with electronic signatures, a full audit trail, and security down to the field level. Each module contains configurable forms, task management, reporting and trend analysis capabilities.

Moving to an electronic system allows all quality events, documents and training tasks to be stored in a secure, centralized repository, making search and retrieval easy during an FDA inspection or a quality audit.

Our Process Designer allows companies to visually model and create an entire Quality Data Management system with drag-and-drop operations in a matter of minutes. Each process step includes department ownership, responsible individuals, entrance/exit criteria, and more.

If employees are unsure what tasks needs to be performed before moving the event, convenient pop-up information screens can be activated. If more detailed information is needed, there is always a link available to your firm’s SOPs.

Once an employee completes all tasks for a given step, a simple drag and drop moves the event to the next process step. An automatic email is sent to the recipient of the event along with a PDF copy of the form. A full escalation model can be set to notify users and managers should tasks or events become overdue.

Reports

Quality Manager includes a host of pre-defined report templates that allow users to be up and running on day one. Reports can be set to run and automatically emailed to an individual or group every day, every week, or only when certain criteria are met.

Dozens of reports are preloaded including:

• Summary reports of open events by person, process step and age

• Aging reports

• Supplier and customer reports

• Audit Log reports

• Event Tasks broken down by person and event ID

• Regulatory Reports

We also include a number of custom reports with each installation.

Ad Hoc queries and reporting, as well as cross-tab reports are easy to customize.  Use multiple search criteria to view open events by age, type, and status, between departments or individual employees.

Trend Analysis

Quality Manager continuously searches for adverse trends to detect potential quality problems. Trend alerts are easy to set up and will run in the background until you disable them.

Users set up rules with a simple dialog interface using criteria from a variety of parameters.  Quality Manager then scours the database, continuously checking to see if the trend rule conditions have exceeded the trend threshold. 

Trend Alerts are useful to:

• verify if corrective actions are effective

• spot adverse trends on a particular product, revision, manufacturing date, etc.

• support monitoring for six sigma programs

Dashboard

The Dashboard gives users an overview of the entire quality system, customer satisfaction, supplier performance, individual and departmental work loads, alerts, overdue items and more.

This is a great tool for upper management to keep informed about the quality assurance activities within the firm. General statistics of aging of events, open items, trend alerts, etc. are easily accessible. Charts can be enlarged for detailed viewing and chart items can be “drilled-down” to see which events make up a chart element.

Department managers can check on their team’s performance by viewing workloads broken down by department, tasks assigned, overdue events, etc. Managers can also view the individual workload of each team member with stats on how long an item has been untouched, which tasks are overdue, etc.

Users have a tool to view all their events, documents that need to be reviewed, training that needs to be completed, along with any private reports or trend alerts that they have running. All of the above can be accessed directly from the dashboard.

Quality Manager integrates quality data management, document control and training to provide one of the fastest ROIs on the market. We offer a host of deployment and training services to ensure a trouble-free implementation process. Most installations can be completed within 3-4 months, including validation and training.

Quality Manager is fully 21 CFR Part 11 compliant and can integrate with most ERP, MES, LIMS and similar legacy systems.