No Engineering Change Order Software?
What happens without engineering change order software? Errors can be made that could lead to product recalls.
Here's an example. On Oct. 24, 2005, the FDA announced a voluntary recall of certain models of Omron instant thermometers because the thermometer tips could potentially overheat and pose risk to young children using the device. The FDA noted that the overheating was a result of a change in the manufacturing process. The agency's press release was brief and did not describe the circumstances of the change that caused the quality problem, but it illustrates the critical implications of change in the manufacture of medical devices in this case, or any other product for that matter. Whether it's a car or a computer or a pacemaker, the goal of regulatory bodies is to protect public safety by ensuring the highest quality standards. Change control and the need for engineering change order software are closely connected with FDA and ISO compliance.
Meet Regulatory Requirements with Engineering Change Order Software
Change control requirements for medical device companies are outlined in FDA's 21 CFR Part 820.30 (design changes), 820.40 (document changes), and 820.70 (production and process changes). 21 CFR Part 820 requires that manufacturers establish written change control procedures, which describe company-approved procedures.
For pharmaceutical companies, written procedures are considered part of Current Good Manufacturing Practice (CGMP) outlined in 21 CFR Part 210-211. Any changes in production and processes must be controlled - meaning recorded, reviewed, and approved by the quality control unit. CGMP requirements are meant to prevent harm by building quality into the development and production of medicines. Engineering change order software helps facilitate CGMP practices.
Manufacturers certified to ISO 9000:2000 and ISO 13485 standards are required to ensure that any changes affecting the quality management system (including product requirements, design, and development changes) should be controlled.
The underlying message in these regulations is that all changes should be made according to approved (approval implies successful testing or thorough review/investigation) written company policies and procedures. Change control procedures have to be written as a way of standardizing instructions. Written procedures are also more reliable compared with passing on information verbally. "Uncontrolled" change in this context refers to modifications made without review and approval of the quality control unit and other departments affected by the change.
In the FDA and ISO environments, strict adherence to approved policies and procedures is key in keeping manufacturing operations in a state of control and it is what makes change control crucial.
Engineering change order software systems are necessary to prevent inappropriate product modifications. A lack of documentation control can cause internal confusion, noncompliance and possibly a product recall or a product liability lawsuit.
The MasterControl Solution for Engineering Change Order Software Systems
MasterControl Change Control™ is a robust engineering change order system designed to simplify the change control process by automating and effectively managing every step of the way, from submission through actual implementation, verification, and close of project. Here's how MasterControl's powerful features address major challenges in change control:
- Improved Communication - Communication breakdown is likely to happen in companies that rely on tools and processes that are not connected. MasterControl is an integrated solution that connects different departments with each other and with data and processes under a secure and centralized system. This connectivity vastly improves communication and increases efficiency through automatic task assignment, routing, scheduling, notification, and escalation of overdue tasks. MasterControl is Web-based, so even suppliers and others outside the company (off-site or traveling employees) who need to participate in change control can do so from virtually anywhere.
- Faster Turnaround - MasterControl integrates and streamlines the entire change control process for faster turnaround. A pre-configured, multi-page form helps collect and track data from submission through close of project. The form incorporates priority level by identifying the change as routine or temporary or emergency. It prompts risk assessment by asking the initiator to evaluate the change in terms of training, validation, and regulatory requirements.
- MasterControl's Explorer - Similar to Windows Explorer, is an easy-to-use tool for search and retrieval of documents. All SOPs and other documents related to a particular change can be grouped together. Users can create virtual folders within Explorers that will automatically retrieve documents based on pre-defined queries. MasterControl's reporting capabilities provide real-time status for all change control tasks.
- Effective Documentation - MasterControl automates documentation and reporting functions for increased efficiency and effectiveness. It automatically provides revision history through the InfoCard, a MasterControl tool that provides basic information about a document. The InfoCard also provides the document's approval history. All changes made to the InfoCard of every document are tracked, including reason(s) for every change. MasterControl maintains a secure, time-stamped audit trail as required by FDA's 21 CFR Part 11. The audit trail documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made to the record.
- Integrates Training with Change Control - With MasterControl, the change control process can be integrated with training control. Any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change. MasterControl can automate the process of distributing online exams with the training, and even includes automatic grading.
For More Information on MasterControl's Engineering Change Order Software
To learn more about MasterControl's engineering change order software systems, contact a MasterControl representative.