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Showing posts from October, 2021

Follow All 21 CFR Part 11 Electronic Signature Guidelines

Many best practices for reviewing and approval information can facilitate compliance with CFR Part 11’s electronic signature guidelines. This includes features like:   Controlled Workflow  When a user wants to make a change to a controlled document or submit it for review in Meridian Cloud, they initiate a controlled workflow to make that change. This forces documents to move through a defined workflow that requires users to pass through pre-defined review and approval steps. This helps maintain compliance and ensure that all boxes are checked.   Electronic Signatures  In Meridian Cloud for Life Sciences, electronic signatures are required when a GMP document is put into a workflow. Each person that must provide their electronic signature will receive an email letting them know that there is a document ready for their review. As each user reviews or approves the document, their electronic signature is manifested on the PDF rendition of the document in the order the...

Performance Management Sings the Blues - It's Broken, the way to Fix It

Most companies and their employees sing the performance management blues. Employees hate it, few CEOs support it, fewer managers roll in the hay well and it doesn't necessarily improve performance. Then, why do it? it is time for a change.   The Problem-it doesn't work   Here are a couple of startling statistics from the WorldatWork: Study on The State of Performance Management.   Only 10% of employees feel middle management champions it Only 12% of employees feel top management view it as business critical Only 30% of employee trust their company's system 58% of employees give their company's procedures a C grade or lower And, Reuters says, 80% of employees are dissatisfied with their performance reviews.   Studies don't tell the entire story. Here are a couple of samples of what I even have heard from working in companies across four continents and a spread of industries.   My boss doesn't know what I do, but once a year he's ge...