Literature Library for Brochures, Manuals, White Papers, & Case Studies
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
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
Instron Connect Architecture and Security Whitepaper
This document describes the architecture and security features of Instron Connect. It is intended to help business and technical decision makers understand how Instron Connect operates within your environment and how it meets your technical security requirements. Additionally, it addresses questions about key issues such as communication through firewalls and network security. The purpose of Instron Connect is to bring operators of Instron systems located anywhere connecting to Instron Connect, customers will experience greater system uptime, a streamlined support experience, and receive important notifications and software updates from Instron.
Whitepapers 2/26/2017 251.9 KB
Understanding gage R&R concepts and its significance for Instron systems
This paper is intended to review the fundamental concept of Gage R&R studies also known as Measurement System Analysis (MSA). Different methods such as ANOVA and Xbar/R can be applied to conduct gage R&R analysis. The paper also presents case studies to understand applications of gage R&R in destructive testing and non-destructive testing and its significance with Instron systems. Furthermore, the concept of type I gage study also known is precision-to-tolerance ratio (P/T) is explained in detail here.
Whitepapers 1/20/2017 399.5 KB
DIC FEA Whitepaper
This paper summarizes investigative testing performed to compare strain results obtained using Instron’s AVE and digital image correlation (DIC) to stress results obtained using Solidworks finite element analysis (FEA)
Whitepapers 1/13/2017 134.0 KB
Strain Measurement Techniques for Composites Coupon Testing
Most approaches to strain measurement in Composites Coupon testing use contacting methods involving bonded strain gauges or clip-on extensometers. Recent developments in non-contacting strain measurement mean these systems now offer similar performance to traditional contacting systems, as well as providing significant other benefits such as the ability to provide full field strain maps.
Whitepapers 12/3/2015 0.8 MB
A Review of Medical Device Quality System Controls for Lab Equipment
The FDA’s Medical Device 21 CFR 820 Quality System Regulation has multiple parts, including a subpart dedicated solely to equipment and facilities controls.The purpose of this review is to discuss laboratory controls pertaining to materials testing equipment.
Whitepapers 11/11/2015 400.7 KB