Quality Control - The Punch and Pizazz of Compliance Software and the Internal Audit

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 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.

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to quality control, or audits management software, please feel free to contact a Master Control representative.

Change Control Software Meets Change Control Goals

An online exerpt1 states the goals of change control as follows:

o Minimal Disruption to Services

o Reduction in "Back-Out" Activities

o Economic Utilization of Resources Involved in Implementing Change

These goals though ideal are not always the final results for life science and high tech (e.g. engineering) companies who implement change control procedures. In fact, change control processes are often implemented at relatively slow pace and are often disjointed due to paper-based and/or hybrid systems of management. Software solutions that streamline or manage change control processes can also be extremely pricy so it's important (if a company wants to move to an automated system of change control management) to search for a solution that makes sense. This article provides information for life science and high tech companies looking for a software solution that will help streamline and implement change control processes with more speed, simplicity and attention to the three goals listed above.

Speed

Speed is essential for effective change control process achievement. A pharmaceutical company for instance may have a product-to-market delay of 30 days, which may not initially seem severe or detrimental. When one considers however that a pharmaceutical company stands to lose around a million dollars per day when products are delayed the situation is greatly aggravated.

This software along with additional quality system software solutions can change the speed at which a life science or high tech product reaches the market. The right software for example can increase the speed of related processes by connecting employees from various departments with the data and documentation controlled in a single, centralized web-based system. The right software solution can also speed processes by automating task assignments, the routing tasks, the notification of employees and escalations when tasks remain incomplete. Another valuable feature is one that allows the quick electronic entry of data on electronic forms that are created according to best practices for change control management. Reporting features are also essential as a feature to the solution since data that remains unreadable or shy of analysis is data that doesn't become a part of the important decisions that these should influence.

Simplicity

The simplicity of a solution like this is greatly increased when the solution is connected with other quality related solutions. For example, this solution that can automatically and electronically be triggered by customer complaints, deviation, nonconformance, audit or CAPA solutions, then managing an entire quality system suddenly becomes a lot less complex. This should also be able to trigger training tasks when necessary.

Goals

The three goals listed above should be met as follows:

o Minimal Disruption to Services- For some companies, this goal might read "Minimal Disruption to Products" and can be achieved in part by making sure that employees are well versed (i.e. trained) on change control procedures and new documentation altered according to change control orders. Training doesn't have to greatly disrupt a company environment. A web-based training solution should simply be configured with the change control solution so that orders may automatically trigger training tasks that will be emailed to specified employees.

o Reduction in "Back-Out" Activities--- No company wants to deal with product recalls but that is exactly what happens when this data is not readily readable and quickly available for analysis. Companies should look for a solution that provides electronic tracking for easily analyzed audit trails that mark the progression of data, documentation and employees.

o Economic Utilization of Resources Involved in Implementing Change--- With the right solution, companies are going to pay a significant price but in the end most companies should make significantly large profits with the aid of the right solution. Pharmaceutical companies for example can save millions and easily receive a quick ROI.

Conclusion

It appears that for life science and high tech companies it's hard to go wrong with a software solution that provides the features and benefits mentioned above.

1wikipedia.org/wiki/Change_control

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. To read content regarding change control and additional quality management systems, please feel free to contact a MasterControl representative.