Instron announced that it is releasing a new traceability module for its Bluehill Universal software to help users achieve FDA 21 CFR Part 11 compliance, among other regulatory accreditations.
Other accreditations included are NADCAP, A2LA and ISO 17025, according to a news release. Traceability is available in Bluehill version 4.18 and is compatible with new systems and existing systems when purchased with a software update or upgrade.
The module features revision history, electronic signatures and an audit trail. Combined with Bluehill’s security features, the module is designed to allow users to know who did what, when and why in their test system.
The revision history feature allows users to view the full history of Bluehill’s methods, tested samples and report templates with details of the affected item and a time stamp.
Electronic signatures replace the need for manual, hard-copy signatures and can be configured for primary, secondary and tertiary electronic sign-off to ensure method revisions and test data are reviewed before changes are implemented or data is publicized.
The audit trail feature is part of Bluehill’s secure and searchable platform to track system-level usage like log-ins and log-outs, along with additions, modifications and deletions to Bluehill files. It is also designed to capture usernames, dates and timestamps for activities while allowing full visibility into all system activities during an audit.