FDA 21 CFR PART 11 COMPLIANCE FOR MECHANICAL TESTING LABS
What is FDA 21 CFR Part 11?
21 CFR Part 11 is a regulation that applies specifically to electronic documentation provided to the FDA. First published in 1997, the original intent was to create a framework that ensured electronic means of recording, approving, and submitting documents was effectively equivalent to handwritten paper documents in terms of security. The objective was to ensure that companies were capable of using electronic record keeping technology as it became more commonly utilized within the industry.
Who Does 21 CFR Part 11 Apply To?
FDA 21 CFR Part 11 applies to any pharmaceutical or medical device manufacturer submitting product documentation to the FDA for approval for sale within the United States or as part of any post-market surveillance activities.
What are the Requirements of 21 CFR Part 11?
Regulatory requirements mainly apply to the processes surrounding electronic record creation, retention and submission. The regulation specifically discusses the need for software validation, use of electronic signatures, a searchable time-stamped audit trail, and access to traceable record copies.
Compliance is best achieved through a partnership between a manufacturer and its equipment suppliers, where the equipment supplier provides the tools to effectively and efficiently integrate the equipment into the manufacturer's quality management system. Instron's Bluehill® Universal software, compatible with static universal testing systems, offers several features designed to aid in 21 CFR Part 11 compliance. Bluehill Central lab management software allows for centralized management of multiple instances of Bluehill Universal, further simplifying the processes necessary for compliance.
Bluehill Universal is the testing industry's most powerful and advanced testing software. Its intuitive workflows are designed to simplify operator training, increase testing efficiency, and minimize safety hazards.
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Bluehill Central software is a laboratory management tool that enables centralized, remote management of Bluehill Universal software applications associated with multiple Instron test frames. The software allows you to remotely manage all Bluehill Universal users, test templates, results, file revision approvals, and audit trail data from multiple Instron systems.
Learn MoreBluehill Universal’s Traceability Module enables users to meet the audit requirements associated with FDA 21 CFR Part 11 as well as those of ISO 17025, Nadcap, and other regulatory bodies. Through seamless integration of electronic approvals, revision history, and an automated audit trail, this powerful add-on combines with Bluehill’s built-in security to provide unmatched data traceability.
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FDA 21 CFR Part 11 Implementation White Paper
Revision History
Revision history allows users to view the full revision history of Bluehill methods, tested samples, and report templates. Each revision contains the details of the affected item, including a time stamp, both the previous and the new value, and the name of the users involved with initiating and, if required, approving the change.
Electronic Signatures
Electronic signatures serve as electronic approvals and replace the need for manual, hard copy signatures. Electronic signatures can be configured for primary, secondary, and tertiary electronic sign off to ensure that method revisions and test data are reviewed before a change is implemented or data is publicized.
Audit Trail
Bluehill Universal’s built-in secure and searchable audit trail tracks system level usage, such as log-ins and log-outs and additions, modifications, and deletions to all Bluehill files. The audit trail also captures usernames, dates, and timestamps for all activities, allowing full visibility into all system activities during an audit.
Traceability’s audit trail offers both a network and local database to accommodate your data management preference. A networked, centralized database offers your lab greater efficiencies and reduced risks when compared to locally managed data. Determining your lab’s IT infrastructure and data management preferences is recommended when considering these alternatives.
Bluehill Universal’s local Traceability module stores audit trail data on a Microsoft SQL Express database that is hosted on the computer running Bluehill Universal connected to the Instron system. The local database model accommodates labs that cannot connect computers to a shared network. Viewing the audit trail and electronically signing files occurs locally on the computer, and each Instron system with a local Traceability database stores its own SQL Express database. Database backup and restore functions can be performed manually in Bluehill Universal.
The network solution for Instron’s Traceability is powered by Bluehill Central, which employs a client/server framework to store all shared audit trail data, files, and settings on a Microsoft SQL Server database. When Bluehill Universal is connected to your lab’s Bluehill Central server, each testing system send and receives data from the centralized database, eliminating the risk of variation and the burden of locally managing each system. Viewing the audit trail, electronically signing files, and user management is performed either remotely in Bluehill Central or locally in Bluehill Universal. Database backup and restore functions can be performed manually in Bluehill Central.