The new Traceability module for Bluehill Universal software is designed to help Instron users achieve FDA 21 CFR Part 11 compliance, as well as accomplish compliance with other regulatory accreditations such as NADCAP, A2LA, and ISO 17025. The Traceability module features three main components: revisions history, electronic signatures, and an audit trail. By using these in combination with Bluehill’s security features, users are able to know who did what, when, and why in their test system, and have the power to prove it during an audit.
Bluehill Security allows lab managers to configure permissions in the software, granting access to trained personnel and limiting access where needed. Bluehill users can choose one of three different security options offering various levels of integration with your organization’s existing security network. For example, lab managers or super users can be configured to have full access to the system with the ability to create and edit test methods, while other operators can be assigned restricted permissions and only be able to run tests on existing methods.
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 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.
Bluehill Universal’s built-in secure, and searchable audit trail tracks system level usage such as log-ins and log-outs, as well as additions, modifications, and deletions to all Bluehill files. The audit trail also captures usernames, dates, and timestamps for all activities. This allows full visibility into all system activities during an audit.
Available in Bluehill version 4.18, Traceability is compatible with new systems as well as existing systems when purchased with a software update or upgrade.