by lmb | Jan 20, 2021 | Uncategorized
Which Probability Distribution Should You Use? There are many probability distributions that are useful in describing common phenomena in the manufacturing and service industries. Also called probability mass functions (PMFs), they can be used to answer questions...
by lmb | Jan 15, 2021 | Uncategorized
ALCOA: A Data Integrity Standard For many years, data integrity has been of particular concern to both industry and global regulatory authorities. Data integrity requirements have increased, especially with the advent of new technologies and their need for rapid...
by lmb | Jan 3, 2021 | Uncategorized
SEVEN Key Components for your Complaint Handling System The Product Complaint Handing system defined in 21 CFR 820.198 (Complaint Files) requires procedures and processes for receiving, evaluating, investigating, remediating, documenting and reporting, record keeping...
by PathWise | Nov 18, 2020 | Uncategorized
The Importance of Good Laboratory Practice (GLP) Protocol There are a few key words that one should have at the forefront of their mind as they conduct non-clinical GLP studies. These words are quality and reproducibility. The regulations clearly state each study...
by PathWise | Oct 5, 2020 | Uncategorized
Interpreting Data to Determine Causality Data can contain much information about a process, and careful diligence is required to recognize and understand anomalies that may be the causes of defects in the process. Investigations often require the use of historical...
by PathWise | Sep 16, 2020 | Uncategorized
Implementation and Management of Data Integrity Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded...
