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FDA 21 CFR Part 11 Implementation - Bluehill Universal's Traceability Module White Paper
The purpose of this document is to inform the end user how the Traceability Module within Bluehill Universal can help meet the technical requirements of FDA 21 CFR Part 11. This document outlines the three key areas in Bluehill Universal (Security, Audit Trail, and Signatures) and also provides a row-by-row interpretation of how Bluehill Universal addresses each of the Part 11 items. Ultimately, each end user should perform their own assessment and create appropriate work instructions that cover the Instron system, Bluehill Universal, the Windows file systems, and the user’s Quality Management system.
Whitepapers 4/26/2022 303.4 KB
Digital I/O Board Guide
The digital I/O board is an optional card which can be added to 5900 and 6800 frames. Digital communication, unlike analog, does not sense continuous signals but inputs or outputs of one of two states: high or low, open or closed. The card used in conjunction with the frame and Bluehill software allows the operator to trigger external or internal events. It allows for 4 input and output channels to be monitored and/or triggered simultaneously.
Whitepapers 4/1/2020 475.7 KB
Steel reinforcement bar: A tensile testing guide
Steel rebar is commonly used around the world to reinforce concrete. Understanding the basics of rebar tensile testing is critical to ensuring product quality.
Whitepapers 11/27/2017 2.0 MB
Instron Connect アーキテクチャとセキュリティー白書
この書類はInstron Connectのアーキテクチャとセキュリティの特長を説明します。ビジネスや技術に関する意思決定に関わる方々に、お客様の環境においてInstron Connectがどのように機能するか、また、技術的セキュリティに関する要求にどのように適合するかを理解していただくことを目的にしています。Instron Connectの目的は、インストロンのシステムのオペレータが、世界中の何処にいても、インストロンのアプリケーションの専門家や、技術サポート部門の技術者、現地サービス部門の技術者と緊密にコンタクト取れるようにすることです。Instron Connectと接続することにより、お客様はシステム稼動時間を増大することができ、スムースで有効なサポートを経験できるとともに、インストロンからの重要なお知らせやソフトウェア・アップデート情報を受け取ることができます。
Whitepapers 10/10/2017 2.8 MB
Analyzing performance of Universal Testing Systems using Process Capability Analysis
Manufacturers/OEMs are constantly striving to develop processes that will produce defect-free products. In this need for zero defect solution, experts strategize different ways to monitor process performances. One such metric is the Process Capability Analysis (PCA). The fundamental concept of PCA requires experts to understand variation of data from the pre-defined tolerance limits for an individual process. As Instron systems typically involve the process of testing and measuring, companies investigate this process’ consistency over multiple samples, over multiple batches and over multiple systems installed at different sites.
Whitepapers 7/12/2017 186.6 KB
Equivalency Testing of Bluehill 3 and Bluehill Universal - a Statistical Review
For medical device companies as part of software validation, GR&R testing is required to prove that new software is capable of producing the same results as the previous software version. Instron conducted a series of tests to prove software equivalence between Bluehill 3 and Bluehill Universal as part of this validation process.
Whitepapers 6/19/2017 368.5 KB