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The CLIA regulations (Clinical Laboratory Improvement Amendments), like many regulations, were a response to less than desirable situations. Like Upton Sinclair's The Jungle (and other manifestations of a heightened awareness of unsafe food handling environments and techniques) resulted in the passing of the Food, Drug and Cosmetic Act of 1906, it was the incidents regarding erroneous clinical laboratory procedures that brought about the CLIA regulations in the 1980s.

CLIA and Technology

In conjunction with increasing regulations and process recommendations for handling those regulations, it's no wonder that software developers are busily creating the *soft* technology that can manage rote regulatory procedures for doctors, laboratories and other life science organizations or individuals. However, finding the software that will effectively mange and streamline documentation and processes associated with CLIA regulations isn*t always an easy task. In fact, when searching online for quality software solutions, a life science professional might find that many software solutions are designed with the manufacturing environment in mind, which is fine as long as the software solution can also provide the following features and benefits:

Look for Software that Provides Document Control

CLIA regulations require (see section 493.1200) documentation, and documentation is always easier to control electronically. Look for a software solution that streamlines processes electronically. In addition, search for a solution that is web-based and easy to access from virtually anywhere. Document control features should also include automation capabilities. For example, document routing and approval should be able to be automated during the implementation of the software. Escalation capabilities should also be automated for best results---on time.

Look for Software that Manages CLIA related Training

Whether in regards to compliance or quality, in a laboratory, employees are going to require continuous training. The CLIA regulations require (see section 493.1445) that training policies and procedural documentation be created and adhered to. So, in addition to the software solution that manages document control, search for a software solution that also provides training management. The solution should include the control of training documentation, and should also provide customized automation for tasks associated with training, scheduling and escalations. Look for a solution that requires trainees to actively participate and *pass off* certain requirements within the training system. Once they have completed their training, electronic signing will occur, the documentation will be tracked, secured, and readily available when it's time for internal or external audits.

Look for Software that Makes the Approval of CLIA-Related Documentation Simple

In a laboratory, the lab director, or lab manager, is required by CLIA regulation (see section 493.1251) to date, sign and approve any revisions or changes to laboratory policies and procedures. These director tasks become tedious quickly since it isn*t always convenient for a manager or director to be in his or her office or to manually sign required paper work. However, with the right GxP software solution, all revised policies and procedures can be approved electronically and the lab director can approve the electronic documents from virtually anywhere.

Look for a Software Solution that Will Manage Customer Complaints Documentation and Processes

Customer complaints come to every life science company. The complaints arrive in a variety of fashions. They may come by mail, by Internet, by fax, via phone, etc. According to CLIA regulations (see section 493.1233) customer complaints handling processes must be systemized.

With the right software solution ((http://mastercontrol.com/solutions/complaints_fb.html), these customer complaints forms can be streamlined electronically.

How does it work?

Well, a customer service professional will enter a complaint (regardless of how it was received) into the software system and then the information will be transferred to the applicable investigation personnel. The right software solution can even be customized to help determine priority levels.

Conclusion: The Ideal Software to Help Manage CLIA Regulations

Ideally, CLIA regulations should be managed effectively with software that controls documentation, automates processes and simultaneously connects departments and procedures.