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.
- 217.0 KB
Bluehill Universal now supports validating a user’s credentials and permissions from Active Directory. This setup will require a Lab Manager to identify what user levels are required, and coordinate with their IT department to create the appropriate Active Directory groups and assign the appropriate users to each of those groups.
- 217.2 KB
Steel rebar is commonly used around the world to reinforce concrete. Understanding the basics of rebar tensile testing is critical to ensuring product quality.
- 2.0 MB
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.
- 186.6 KB
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.
- 460.1 KB
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.
- 178.1 KB