Success is the result of hard work, dedication, and perseverance. We have been in the market for 20 years now, we passed thru ebbs and flows but never gave up. We made sure that every single time, we work to the best of our ability to offer quality products and services to our clients. We also believed in innovation, because at Intellect, innovation is what we do every day! Innovating is crucial to the continuing success of any organization. We make sure to share this belief and culture with our business partners, through every product we develop and provide. The reason why, Intellect’s Document Control Software (DSC) succeeded to stand out among competitors. Not to mention, its many key features like: Archiving and retention, compliance tracking, collaboration tools, documents retention, and version control. 

We all know that quality is important, but quality initiatives sometimes carry less weight for others in your organization, especially if the resulting benefits are not visible to them on a regular basis. Effective reports help to communicate and establish the value of quality management activities. Just as importantly, reporting supports accountability by providing a visibility to the things that might not be working so well. That, in turn, can provide the basis for course corrections that ultimately help the organization to achieve its business objectives. 

We have all encountered people at one time or another who regard quality management as being far too bureaucratic, – dominated by unnecessary processes and excessive documentation requirements. In many organizations, unfortunately, this attitude is the norm. That usually happens when top leaders within the company are not fully committed to quality management programs.  

A well-defined corrective and preventive action (CAPA) process is intended to identify problems, understand root causes, resolve issues, and take corrective action to prevent the recurrence of those problems. While the results are well worth the effort, designing and implementing a good CAPA process comes with some challenges. Here are some of the most common problems we see when companies are struggling with their CAPA processes. 

Paper has forever been the universal proof of compliance.  

For many companies in FDA regulated industries, including pharmaceuticals, medical devices, labs and life sciences, compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a critical requirement.

The build vs. buy dilemma isn't new to businesses considering investing in a quality management system. After all, they often have very specific needs from their QMS solutions (depending on the regulations that apply to them, their desired process automation maturity and manufacturing velocity, their monitoring and analysis expectations, and their unique documentation and data processes, among dozens of other things).