Quality Control : Compliance Software and the Internal Audit

By: Marci Lynn Crane

In the world of FDA, ISO, EMEA and SOX regulations, life science, manufacturing and high-tech companies groan under the weight of regulatory compliance and audit procedures. Like so many unpleasant situations however these “regulation situations” are ameliorated only after a violent coup d’ etat.

What?

Well, in other words, the more control a company gains over their respective compliance and audit procedures the less vicious those procedures will seem.

So, how does it work?

Quality Control with Compliance Software
You are probably well aware that the idea of compliance software was definitely an idea worth rejoicing over. However, though the idea itself is worthy of eureka-praises, the problem with compliance software is that there are so many varied solutions it is hard to know where to start. It’s like choosing a personal chef. Just getting up one morning and hiring someone with the title “chef” will never work. You have to take the time to find who (or what) works for your unique taste buds. With compliance software, the process is similar. You have to take the time to find a flexible solution that fits the needs of your company. However, before you run off to start reading compliance software reviews let this article provide you with a simple suggestion:

Start by finding compliance software that simultaneously manages your quality control processes.

Sound impossible? It’s not.

Quality Control and Compliance Solutions: A “One-Two” Punch to the Regulatory Gut
You may not have realized it but there are http://www.mastercontrol.com/solutions/quality_management_fb.html"">quality control software solutions that allow you to manage both quality-control related processes and regulatory compliance. For instance, when you look for compliance software look for a solution that will manage your regulatory compliance requirements and quality factors such as documents (quality control and other doc types), change control procedures, CAPA procedures, customer complaints, CAPA related training, additional training, audits, and submissions to regulatory parties such as the FDA. If you don’t want to invest in all of the solutions named, find a software solution that will allow you to mix and match the featured quality control applications that you need. With this type of flexible software, the weight of the quality control and regulatory compliance burdens will thankfully (and metaphorically) be akin to feather, a butterflies or objects equally sylphlike!

Quality Control and the Internal Audit
Once you have a quality control/compliance software solution, audits will be far easier to manage. However, audits can still be exasperatingly stressful since the behavior of employees and the speed and productivity of a workflow is still somewhat dependent on the efficiency of people who are of course prone to make mistakes. So, another way to gain control and to make the audit giant cower is to simply practice internal audits on a regular basis. After all, audits are not secretly clandestine efforts that you couldn’t plan and produce yourself. An audit is simply the process of repeatedly observing a system or a process, and determining whether or not that system or process meets regulatory standards and the prioritized goals of your company.

Quality Control: Put the Internal Audit into Practice
Have a clever personnel member from your company devise an internal audit process. Do research on exactly what the FDA, the ISO and SOX are looking for and beat them to the punch! That way, when it’s time for 2nd and 3rd party audits, you and your employees will breeze through the process like you were born for it.

Remember! Effective quality control and compliance software research will help your company take the next few steps towards easier compliance and more effective productivity.

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