Software validation is integral to a Life Science device manufacturer’s Quality Management System (QMS). The guarantee provides confidence that the software application used at the user site meets industry specifications and regulatory requirements.
It involves inspections, reviews, and walkthroughs with stakeholders and users to verify that the intended goals are being achieved. It also includes gray-box testing, where the testers need more knowledge of internal features and the structure of the software.
Industry-Specific Solutions
When choosing the right validation software solution for your industry, make sure it caters to the unique requirements of your specific business. The best solutions provide functionality that reflects and adheres to best practices, standards, and regulations. They are also constantly updated as new standards and regulations are introduced.
For example, the banking industry requires a robust identity verification solution to identify legitimate customers from fraudsters, protect assets and ensure compliance with regulations. Risk and compliance teams must be able to perform KYC/KYB and AML checks and verify the identity of all prospective customers. This is a complex and time-consuming task. The right validation software should automate this process and save the organization valuable resources and money.
General solutions often offer themed features and optional add-ons that help users tailor their software to specific industries. For instance, they may include a tool that allows users to create custom forms and labels or a workflow management system designed for field service workers. These features and tools allow companies to develop an enterprise resource planning (ERP) system that fits their industry needs. This helps reduce the cost and time required to validate and maintain the solution. These specialized tools are often easier to use than their generic counterparts. They can even speed up the validation process by reducing documentation and focusing on critical features.
Industry-Specific Processes
Many different processes go into the electronic validation of software. It’s impossible to describe them all in one document, but several broad concepts can guide designing and conducting comprehensive software validation. This includes planning, verification, testing, traceability, and configuration management.
Industry-specific solutions consider these processes and are designed with them in mind, allowing you to use the best tools for your business. This helps eliminate wasted time adapting a generic solution or dealing with a vendor who doesn’t understand your specific needs.
These solutions are also more cost-effective and can often be scaled up or down as your business grows or contracts. This makes it easier to work with original equipment manufacturers or clients who have strict requirements and can’t easily be accommodated by a generic solution.
However, you may still need to be ready to rip and replace an existing solution. That’s why the Tech-Clarity buyer’s guide focuses on identifying high-level essential aspects of a requirement management and validation solution, including simple checklists you can use as part of your buyer’s journey. Download your copy here. Michael is passionate about helping organizations improve how they manage their requirements and validation process. He believes that robust conditions and validation process results in higher product quality, lower failure rates, and faster time to market.
Industry-Specific Knowledge
Industry knowledge, or “industry IQ,” helps professionals gain credibility and establish themselves as subject matter experts. It also provides a strong foundation for future professional growth and development, positioning individuals to select the most brilliant career moves for long-term success.
Deep industry knowledge is about working in a particular industry and understanding the nuances and trends. This includes the competitive landscape, key players, regulatory environment, and specific challenges and opportunities for that field.
Vendors with industry-specific knowledge can offer accurate work estimations and provide a solution that is a good fit considering the scope of services and software features they can deliver on a given budget. They can also have more agile solutions, chopping projects into smaller units for greater efficiency and transparency.
For example, a forensic identity verification solution should support multiple workflows based on an organization’s resources, needs, and budgets. The solution should also allow AML teams to customize their workflows with different data sources, including watchlist screening and synthetic checks, in addition to the more traditional identity verifications, such as name, address, DOB, SSN, etc. This enables organizations to approve legitimate customers more quickly, adhere to compliance requirements and reduce the risk of fraud. This flexibility is possible when choosing an industry-specific software solution, such as Unit21’s Identity Verification Solution.
Industry-Specific Tools
Choosing the right validation software solution for your industry requires more than just knowledge of what is needed. The software itself must be designed to meet industry needs as well. This includes the necessary tools for identifying and analyzing data to make informed decisions and the ability to adapt and change in response to evolving business needs.
For example, identity verification solutions need to be able to rely on multiple independent data sources that correlate information to produce the best possible match. They must also be able to create tailored workflows that fit each organization’s resources and budget.
The same is true for other industries with specific requirements. For example, a shipping company may use industry-specific logistics management software. This allows them to get access to unique software features that apply directly to their operations without investing large amounts of money in developing a custom-made solution themselves.
Another essential feature to consider when choosing a validation software solution is whether the solution meets regulatory compliance requirements. For instance, some validation software solutions incorporate the FDA’s user site software validation (IQ/OQ/PQ) framework into their software development process. This helps ensure that a full range of testing and verification techniques are used to validate software before it is released to the public.