The various regulatory overheads are complex, and often intersect in ways that are less than clear, but best practices for the requirements to validate a software system are well understood. Table 1 answers this question by

with its clients to assist in crafting and understanding software systems in regulated environments.

Whatever the form, the consequence is the same. The lack of proper software infrastructure begins to drag on the overall efficiency of the company. When left unsolved, this problem will impact productivity, sap profitability, and in severe cases, create an existential threat to the companies continued existence. Even worse, the overhead of changing initial decisions when interacting with regulated environments can seem frustrating at best and overwhelming at worst. However, this doesn’t have to be the case. This whitepaper will briefly examine key best practices identified by Accendero Software during work

Any executive managing a scientific enterprise and implementing a first-in-industry methodology encounters the same problem. Without fail, any decision made during the implementation of the software infrastructure will be challenged by ever changing process requirements and impediments. In some situations, this takes the form of a vendor provided solution being too brittle to accommodate cumulative changes. In others, this is because the process as it is constructed is trapped in legacy technologies not meant to accommodate it.

Software implementation: Best practices for software systems in regulated

environments

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Once the regulatory environment for a process is considered, it becomes necessary to evaluate the process being supported. Table 2 below details a few of the questions that should be asked and how those questions should be thought about:

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the end of all development for that piece of software. Having gone through an onerous validation process to implement software within their environment, a company was unlikely to want to pull down production to do it again. Creating a test environment to validate software outside of the production environment was, for many organizations, fiscally unfeasible.

Thankfully, the introduction of various cloud-based solutions has transformed the maintenance and continuing development of software governed by regulatory systems.

Exact copies of production environments can be generated for minimal cost. Because these environments are demonstrably the exact same as the production environment, validations can be rapidly performed on improved software. Figure 3 identifies how a company can think about continuing development in this environment:

Software implementation is difficult and fundamentally challenging. It poses risks to companies beyond simply “the software doesn’t work right” and up until recently, the fiscal burden to try and change a custom piece of validated software effectively precluded any continuing development. However, this is simply no longer the case. Following Accendero Software’s best practices will allow your company to rapidly implement and iterate software to support your novel process without seriously impacting your company’s fundamental ability to operate.