Electronic Change Control Regulatory Requirements
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. These procedures can be effected through electronic change control.
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.
Manufacturers certified to ISO 9001:2008 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. Manufacturers can use either paper-based or electronic change control systems.
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 regulated and ISO manufacturing environments, strict adherence to approved policies and procedures is key in keeping operations in a state of control and it is what makes change control crucial. When considering methods for controlling change, a company can choose to implement a paper-based or electronic change control system.
Electronic Change Control Systems Should Provide Best Business Practices
Because companies now create and store most of their business information in electronic systems, it makes sense that documenting change would move to electronic systems, too. Electronic change control systems should support a manufacturer's business processes, allowing it to easily create change orders, submit change orders for review and provide all associated documents that instigated the change.
An electronic change control system also requires the use of electronic signatures. For FDA-regulated companies, an electronic signature is defined as "a computer compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent to the individual's handwritten signature."
Remember chaos? The use of an electronic change control system requires the development of a set of internal procedures known as standard operating procedures (SOPs) that control chaos. These clearly state when electronic signatures, electronic copies and paper copies are appropriate in the workplace. An electronic system sets rules for updating all electronic documents and mandates when and how electronic signatures will be used.
The MasterControl Electronic Change Control Solution
MasterControl Change Control™ is a robust electronic change control 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 electronic change control system 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's electronic change control system 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 Organizer, 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 Organizers 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 in its electronic change control system.
It automatically provides revision history through the InfoCard, a MasterControl tool that provides basic information about a document in this electronic change control system. 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 electronic change control system 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 Electronic Change Control Software
To learn more about MasterControl's electronic change control system, please contact a MasterControl representative.