Internet-Based Software in Highly Regulated Industries
Industries having the United States Food and Drug Administration as their regulator have to put in lots of efforts in order to implement business software for their needs. After identifying an application that best suits their needs and carefully purchasing it, it is a requirement that the software applications undergo a scrutinizing validation process to ensure compliance with FDA standards. The validation may take weeks or even months for the actual implementation of the software to see the light of day. Such inconvenience has led to most companies to drift away from the use of traditional software applications to more modern software-as-a-service applications. SaaS applications entail the use vendor specific services whereby the vendor hosts the applications on one end, and the regulated companies access the applications via the internet on the other end. The vendor develops and maintains the software at their locations. Companies subscribe to the SaaS applications depending on the number of users supported.
The model of SaaS applications is quite convincing and, as such, the uses SaaS applications are increasing tremendously. A wide range of benefits is the main causes of the shift by customers to increased use of SaaS applications. Some of the benefits include; mobile workforce support, availability of the latest versions, scalability depending on subscription type and the increased cost savings of implementing SaaS applications compared to conventional software applications. Regulated companies stand to gain in such software models of business applications. Essentially, FDA-regulated companies have a responsibility to ascertain that the SaaS applications they subscribe to have standard approach validations. The validation approach provides the documentation necessary for auditing purposes by the FDA or other relevant authorities.
SaaS applications implemented by FDA-regulated companies, however, face certain complications. One of the major worries by FDA-regulated companies associated with the use of SaaS systems is the lack of its direct control. Such companies do not have any power over the SaaS systems as the vendor hosts them at his location. As such, most companies prefer to conduct quality research on different supplier systems before making any subscriptions. Another area that raises concern is the proposed changes in SaaS application. For most vendors, environments keep on changing thus necessitating changes in software design and implementation with minimal communication with subscribers. The challenge in such scenario for FDA-regulated companies lies in the fact that testing and review of such changes must take place. Documentation of related results is important for compliance purposes with FDA policies and procedures.
All in all, the benefits of SaaS applications outweigh the limitations. As such, the use of SaaS applications is bound to continue increasingly as companies strive to capitalize on the advantages. Vendors of SaaS applications, however, must also strive to accommodate the needs of FDA-regulated industries in a more flexible manner based on their regulatory controls. Such a move will greatly contribute to compliance to FDA standards. Most importantly, there are already systems and technologies in place for ensuring the development of compliant systems. The only requirement is the adaptation to the SaaS model. Evidently, internet-based software applications have a pace in highly regulated industries.
Dougherty, J., & Lengel, W. (2012). Does Internet-based software have a place in highly regulated industries? Retrieved November 18, 2014, from http://clarkstonconsulting.com/wp-content/uploads/2012/03/a-tangled-web.pdf