CBI Scene Blog

Monitoring and Auditing with Limited Resources – How Often Should Comprehensive Risk Assessments Be Done?

Posted by Evanna Payen on Jan 16, 2018 2:43:54 PM

Comprehensive risk assessments always seem to make it onto a to-do list, but end up being considerably more difficult to take off of that same list. They take time, effort, and resources - the trinity of what runs competitive businesses in the pharmaceutical industry. It can be tempting to keep pushing them off, involving yourself in another one of the endless checkboxes to take care of - but that's a very bad idea. The very nature of risk assessments is to prevent that looming, nasty, "what if" that could derail your projects or dismantle your clinical trials. It's finding the leak before the pipe bursts, or detecting the first wisp of proverbial smoke before a fire can start in earnest. In other words, neglecting to iron out a regular schedule of risk assessment reports could have disastrous consequences.

A Year-to-Year Assurance

While the products you work with may change subtly over the course of a year, chances are that the underlying framework of your workflows, your research and development, remains largely unchanged. That's why annual comprehensive risk assessments are an excellent idea. When you time them to align with the fiscal year, you'll have reliable material and labor deductions that can be used for tax liabilities, as well. Not only will this help you start the year off with safety in mind, it provides an excellent opportunity to point out procedures and expectations to any new hires in the new year.

Supplement With Monitoring

While an in-house annual audit is a great start, don't hesitate to support your safety goals with monitoring services as well. Not only will using monitoring services, software, or devices help to course-correct any compliance issues that arise, the data they provide can also be used as both a backup and accuracy fact-check for internally gathered data. As any pharma industry company that has run a trial will attest, the more comparable streams of data available, the more refined - and trustworthy - the results.

Stay Up-to-Date

Ignorance of the law is no excuse for breaking it, to paraphrase an old saying. In order to stay in compliance, you'll need to be aware of any changes in rules and regulations for your industry. One of the best ways to stay informed is to attend specialized conferences, such as Compliance Monitoring, held February 27-28th in Philadelphia, PA.

You'll be able to attend panels held by industry experts, learn new tips and techniques for making comprehensive risk assessments easier to handle, and this annual gathering also aligns neatly with annual audit schedules. If you want to keep your company, facility, and staff safe to the best of your abilities, you'll need to register now: attending is your best opportunity to hear from regulatory agencies, benchmark with your peers and come away with tangible takeaways to enhance your compliance monitoring activities.

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Topics: Compliance & Regulatory, Compliance Monitoring