Confusion and controversy over Part 11

In essence, the rule is meant to permit bioscience organizations the best flexibility in implementing the specified controls, but is very hospitable interpretation. There has been much controversy and confusion about Part 11 over the years, with doubts of its comprehensiveness being a key argument. The constant revision of its guidance documents and therefore the continuous redirection of the rule plagued opinions and have only now began to clear a number of the confusion.

 

 

Why can we need the regulation?

By introducing the 21 CFR Part 11 rule, the FDA have essentially enabled the bioscience community and other FDA regulated industries to streamline business processes, reduce turnaround and costs, all by establishing standard criteria for the utilization of electronic records and signatures. If it weren't for this rule, we might be unable to manage records and other content electronically, significantly increasing the danger of human errors, increasing operational costs and increasing time-to-market for pharmaceutical products.

 

 

Life science applications for 21 CFR Part 11

There are three main areas during which FDA regulated companies must check out as primary areas of focus when handling 21 CFR Part 11:

 

Features of Your System - In accordance with 21 CFR Part 11 there are a variety of features that you simply are required to possess in situ when implementing a computing system to manage electronic records and processes. Assurances for audit trail functionality, electronic signatures, security and data integrity, records retention and file formats are to call but a couple of .

 

Standard Operating Procedures - like all regulated industries, the businesses that operate within them use Standard Operating Procedures (SOP’s) to control and describe how they're to try to to things. Currently in accordance with Part 11, there are around 9 IT SOP’s needed to deal with the IT Infrastructure requirements.

 

System Validation – When implementing an electronic system for the utilization in regulated activities, you've got to make sure that you simply document that the electronic system is fit its intended use. In other words, demonstrate that your system does what it should do. you want to even have controls in situ that allow you to spot when the system doesn’t function as per its intended use. Here you ought to be utilizing your SOP’s and industry best practices (such as outlined in GAMP 5) to facilitate the validation process. However, before you begin to even believe validating your application, there are some steps to require first.

Document Management

We've all experienced those late-night sessions running around trying to urge those last pieces of regulatory content finalized for our upcoming drug application. We tell ourselves, this is often the last time i'm getting to do that , however, ultimately, we all know it isn’t.

 

Why can we often find ourselves during this situation?

 

Usually, it's thanks to a scarcity of designing behind the regulatory submission process, and complications caused by an outsized , dispersed team involved in producing all of the varied pieces of regulatory content. Then we start working towards a replacement drug application and it seems this problem is multiplied 100-fold!

 

Getting submissions in on time is vital to speeding up time to plug , however, time pressure also can have a negative impact on quality, which ultimately results in rejected submissions, increased costs and even longer timelines. By combining better regulatory submission process planning with the utilization of technology, we will begin to positively impact the results of our regulatory submissions.

 

So, how can teams ensure their regulated content is submission-ready?

 

There are multiple factors that contribute to improved submission readiness to suits bioscience regulations, and it's important to obviously define what these factors are and the way you'll manage them. Understanding and identifying where technology can help improve the implementation and control of those factors is additionally key and can dictate how you develop your plan.

 

Developing a concrete submission readiness plan which outlines these factors are often a useful gizmo in ensuring that everybody is on an equivalent page which you've got properly thought out how technology could improve your submission readiness. Let's discuss a number of the six main factors that improve regulatory submission process and submission readiness and the way leveraging collaborative technology can help.