CSA - Is Computer Software Assurance Cheating?

 CSA is literally catching fire, but there remains a lot of bad information out there. Something I hear (or some variant of) every week is: "Is CSA cheating?" If CSA is a simplified, streamlined approach (test more and document less), how can it possibly deliver better results than a traditional Computer System Validation (CSV)? That just doesn't add up and other regulators (or customers who audit my organization) will think I'm cheating, won't they? Read More.

Location: 1512 Artaius Pkwy Suite #205, Libertyville, IL 60048, USA

Comments

Post a Comment

Popular posts from this blog

US FDA Process Validation Guidance

Image
The U.S. FDA (Food and Drug Administration) provides guidance on process validation for the pharmaceutical industry. Process validation is a critical aspect of ensuring that a pharmaceutical manufacturing process consistently produces a product that meets its predefined quality attributes. The FDA's guidance on process validation emphasizes a lifecycle approach, which includes three stages: Stage 1: Process Design: This stage involves understanding the manufacturing process and defining critical quality attributes (CQAs) and critical process parameters (CPPs). During this stage, manufacturers design their processes to ensure that they can consistently produce products that meet quality requirements. Stage 2: Process Qualification: In this stage, the manufacturing process is evaluated to determine whether it can consistently produce product that meets predetermined specifications. Process qualification involves executing process performanc...
Read more

🔍 Understanding FDA 21 CFR Part 11 ERES Requirements

 Unlock the secrets of FDA's electronic record and electronic signature (ERES) compliance under 21 CFR Part 11. 📜🔒 📌 Navigating the digital landscape in regulated industries is no small feat. Our enlightening white paper delves deep into the intricate world of FDA 21 CFR Part 11 ERES Requirements. Discover how to harness electronic records and signatures to meet FDA compliance standards and elevate data integrity. 🔬  Key Insights:  - Demystify the core concepts and scope of 21 CFR Part 11. - Explore the importance of secure electronic recordkeeping. - Gain a roadmap for implementing electronic signature protocols. - Learn from successful case studies of seamless FDA compliance. 🚀 Elevate your regulatory compliance game and embrace the digital future. Download our white paper now to master the art of 21 CFR Part 11 ERES Requirements and ensure data accuracy with confidence. 📥 Download Now - 21 CFR Part 11 ERES Requirements (complianceg.com)
Read more

Medical Device Packaging Validation | Compliance Group Inc

Image
Medical Device Packaging Validation is a crucial process in the development and manufacturing of medical devices. Packaging validation ensures that the packaging system for a medical device is designed and tested to meet the necessary requirements, including regulatory standards, to ensure the safety and efficacy of the device. The packaging of a medical device plays a critical role in maintaining the integrity of the product throughout its shelf life and during transportation. Here are key steps and considerations in the validation of medical device packaging: 1. Regulatory Compliance:    - Understand and comply with relevant regulatory requirements, such as those set by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). 2. Packaging Design:    - Develop a packaging design that considers the specific needs of the medical device, such as protection from environmental factors, sterility requirements, and any unique characteristics of ...
Read more