The risk of non-compliance and non-conformance is critical in the development of any system and impacts the success of the development at hand. For developers, taking risks and being innovative is critical in the course of finding new solutions or developing new ideas. However, it is important to observe regulatory requirements that are set in the regulatory domain to ensure aspects such as safety and performance quality are observed (MasterControl, 2017). FDA and ISO regulations, in particular, are quality system regulations and concepts that require organizations or individuals to understand the regulatory obligations for the product or services they create to reduce the risk of non-compliance and non-conformance.
FDA regulations call for the maintaining and documenting of current, reviewed, approved, accurate, and recorded written procedures to be followed. It encompasses the entire design process of a system into the quality system regulation and seeks to ensure sound quality principles are applied in the development of a system. The FDA regulations also stipulate the requirement for risk analysis as part of the design validation process. The key to the establishment of a documented controlled process and validation is to review the concepts used, review applicable regulations and standards, and make sure there is a consistent format that is used. ISO (International Standard Organization) standards are published standards that seek to eliminate errors and wastage while increasing productivity with respect to worldwide commercial and industrial standards. Risk assessment is a mandatory requirement in relation to ISO regulations and serves to assure intended outcomes and to prevent undesired effects.
Role of MCQM System in Connecting All Processes Critical to Compliance
For developers and system creators, it is critical to comply with the set operational requirements for the selected system and to describe them in the functional specifications. MCQM is a web-based solution that helps in the process of linking the operational critical measures to relevant quality processes based on regulatory measures and, hence ensure continuous compliance. The web-based nature of MCQM also ensures that a secure repository is used for search and retrieval processes thus making it easier and proactive. MasterControl is an application used to integrate functional/business processes of systems and based on automation, manages aspects such as document control to ensure that a system in its totality complies with FDA and ISO regulations (MasterControl, 2017). MCQM is built based on preset regulatory frameworks and standards thus in its application to a system, it is an active step towards ensuring that a system always functions and runs based on acceptable, traceable, and standardized functions and procedures.
The MCQM offers documentation management software applications and provides tools that are necessary for the verification and implementation of the system. The subsystems of quality are connected through the MCQM through automated routing that makes it easier to audit a system and train users. This way, subsystems of quality can be streamlined and simplified to help in developing easier methods of approval and reducing document cycle time; this helps to ensure sustained compliance. Through the automated functions that connect quality and operational subsystems and web-based documentation management, it becomes easier to detect and track any errors in a system and ensure that a system is always ready for inspection and auditing.
Summary
In system development, there may emerge fears about the relative lack of reliability in relation to operational aspects and non-compliance as far as regulations are concerned. Aspects such as quality system documentation and risk assessments as well as validation are important and it is important that developers seek system-wide solutions that will enable a timely and proactive scrutiny and auditing of a system. From the demos, the greatest lesson is that running a system that is compliant requires not only an understanding of the quality and operational subsystems but also having a reliable and active system underlying it that connects the subsystems and the logical functional aspects to the overall system so that it is not only readily available for inspection and auditing but also to ensure that the regulatory framework is observed as the system is developed and operationalised. It is thus advisable to develop a compliance quality system in-house because the risk of non-compliance is a real threat in the development and operation of systems. A quality System should always comply with the regulations in that it is documented and demonstrable and thus the need to have proactive compliance measures (Weinberg, 2011). In-house compliance system means that developers will use the same procedures as well as records in relation to compliance with quality system and in design control with a focus on the self-regulatory nature of the quality system.
References
MasterControl. (2017). Online Resources. MasterControl, Inc. Retrieved from http://www.mastercontrol.com/resource/online_resources.html
Weinberg, S. (2011). Cost-Contained Regulatory Compliance: For Pharmaceutical, Biologics, and Medical Device Industries. Hoboken, New Jersey: John Wiley & Sons.
