Life Science Software & Quality Control Standards

By: Marci Lynn Crane

When it comes to quality control (in FDA regulated environments) and the implementation of quality related findings, successful performance is often determined by two factors:

  1. Whether or not managers and employees really concern themselves with superior quality standards, AND

  2. Whether or not the company in question has access to the right technological solutions.
A New State of Quality Control
25 years ago--even 15 years ago--quality control consisted of menial tasks that were managed by people. Like many menial tasks however, those quality control, rote to-do lists can now be managed by the levelheaded computerized technology we have all come to rely on more than we do on our own mothers.

Yes. Technology has done it again.

However, it is unfortunate that many of the right people have not been introduced to the right technological solutions. For instance, life science (biotech, pharmaceuticals, medical device, etc.) and high-tech professionals whose employees continue to fumble over quality control processes that plod at a sluggish pace and are inevitably error-prone are very often oblivious to the fact that their paper-based and hybrid controlled quality systems are debilitating every extant project and department within their respective companies. If they would take a comparatively small amount of time to find the right quality control solution(s), they could not only dilate their production and accuracy but could, in addition, relieve their employees who suffer from the constant humdrum of menial and repetitive paper-based quality management tasks. These employees, with the right technological booster, could actually produce real results.

So, if you are a life science or high-tech professional and are considering the escalade of your quality control system, take the following into account:

A Quality Control System Should Control Documentation
Whether your company routes design files like rain falls in the Amazon, or you deal mostly with calibration or audit forms, quality control relies heavily on documentation. In addition, if compliance (i.e. FDA, ISO, CLIA, EMEA, SOX, etc.) is to be controlled simultaneously regulated documents must be controlled simultaneously with paralleled quality processes. Look for a quality control system that discredits paper and takes document control online. Not only will you save money (in the long run) you’re your quality-control-is-my-worst-nightmare ulcer will dissipate like dew in the morning. Look for a quality control system that will automate repetitive processes. Whether those processes consist of routing, approval, archiving, editing, etc. find a solution that works for you. Find a solution that gives you more time to think about the aspects of your business that are really important.

A Quality Control System Should Consist of Parts that Integrate
A quality control system shouldn’t consist of document control alone but it shouldn’t overburden you with 35+ varied quality control solutions that you have to use for the benefit of your company’s sanity (yeah right!). Look for a system that allows you to select the solutions that your company needs and make sure those solutions can be integrated into one streamlined system. For instance, you may want a system that controls quality and compliance documentation, deviations, customer complaints, CAPA (corrective and preventative actions), equipment calibration, change control and training procedures. If that’s enough for your company, find the software provider that will proffer those solutions. No more. No less.

A Quality Control System Should Include Training and Additional Services
Software without training is like a can of olives without a can opener (i.e. very frustrating). Look for a quality control system that includes not only training, but validation services (see below), technical support and of course---implementation.

Quality Control Solutions Should Afford Validation Services
According to the FDA’s CFR 21 Part 11 regulation, quality control software solutions must be validated. Validation can be time consuming (especially if you are raring to utilize your new system), so when you look for a quality control system, look for a provider that provides the system and validation services.

There are many more factors that should be considered when upgrading or “first-time purchasing” a quality control system. Start by considering your needs. User requirements should be the basis for every purchase.
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