SOLUTIONS

Overview

Audit Management

Batch Records System (EBR)

Change Control

Complaints Handling

Corrective/Preventive Actions (CAPA)

Device History Records (DHR)

Deviations

Document Control

Engineering Change Orders (ECO)

Equipment Calibration

Investigations

Nonconformance Management

Out of Specification (OSS)

SOP and Document Management

Training Management and Certification

Equipment Calibration

Equipment Calibration is another process that is included with the Quality Module. Setting up calibration schedules with the forms tool is a simple procedure where users are able to configure multiple types of calibration schedules for equipment, including short term calibration, long term maintenance, R&R study, repair activities and others. Forms can be configured to capture such information as: availability for use, ownership, location, department, classification, status of equipment life, repair activities, quality costs, warranty information, equipment usage history. In addition, an unlimited number of user-defined fields can be added so the forms make sense for how your company does business.

In case of product nonconformances and recalls, the ability to cross-reference equipment and product helps with traceability, which saves time and money and is essential in root cause analysis.

Maintenance task profiles can be set to automatically email users and tracks the progress of the tasks. Users are able to use their electronic signature to sign off the completion of tasks, and all records are stored in the database for easy retrieval. A full escalation sequence can be set for overdue tasks. Users are also able to track their tasks in their dashboard, along with training items, documents awaiting their approval, and other quality events.

Since the equipment calibration is part of the Quality Module, different events including CAPAs, deviation, OSS can be linked to a calibration form for future reference. External documents such as vendor specifications or work instructions can be attached to calibration events, and when integrated with the Document Control module current SOPs can be pulled up for reference. Further integration with the Training Module ensures only certified personnel perform critical calibration and R&R activities.

Title21 Software’s Equipment Calibration:

• Meets 21 CFR Part 11 requirements with a signature manifestation that includes name, date, time, and meaning of electronic signature (reviewed, approved, rejected, etc.)

• Decreases time spent tracking down pieces of information; a central repository allows for easy search and retrieval

• Allows companies to become virtually paperless

• Is part of the Quality Manager Module, so other quality events such as CAPA, deviations, complaints are linked to ensure compliance with FDA regulations and ISO quality standards

• Integrates with the Document Control and Training Modules to create a “Closed Loop” Quality Management Solution

Some of the reports available include:

Equipment Calibration History: Shows the calibration of all equipment during a specific date range.

Equipment/Production History: Details which production lines were produced on specific pieces of equipment within specific date ranges.

Equipment Inventory: Includes availability for use, location, classification, status of equipment life, repair activities, warranty information.

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