Quality and Compliance Solutions

GxP Software Selection Process

In the modern world with the rapid growth in Technology, organizations have turned to use computer systems to become more productive and automate their processes. With the intent to automate the existing processes, organizations reach to vendors for applicable computer systems to implement at their sites and facility. I tried to explain important things to consider while selecting a vendor and software applications here.
The general practice is that most of the companies select software applications for organization based on the references from other companies, resources, third party reference or industry well known products/applications, instead of checking all requirements.

The following points can be used checking a product/software application for our use:

Fit for Use: The organization first should list all functional requirements of intended usage of system at their site and ensure that system meets all requirements. This activity could be done with sand box or trail site for few days through vendor or we can include these requirements in our Request For Proposal (RFP) form and get responses from vendor. The computer systems should have an ability to configure based on business and regulatory requirements. The points need to consider could be accessibility, roles setup, workflow requirements, report requirements, electronic signature requirements, integration capabilities, migration capability etc…
Business Requirements: The organization need to consider the business requirements like features and functionality, performance of the application, support for application, documentation, training and reporting features for internal management.
Regulatory Requirements: Always consider to comply with all applicable regulations while planning to implement computer systems at regulatory companies. We will be subject to one or more regulatory agencies and their associated rules and regulations depending on the scope of our activity. Few of the applicable regulations for our check are CFR Part 11, EU Annex 11, PICS, HIPAA and GDPR and many more
Usability: ‘Usability’ is the process of identifying users’ needs to ensure a product can achieve specific goals effectively and efficiently, which results in overall satisfaction and success. The user is able to understand and navigate through the system easily and look and feel should be good and self explanatory to operate the system with training. Few points to consider while designing the application is ‘Design of User Interface, Ease of Learning, Efficiency use, Memorability, Error prevention and user satisfaction’
Any product that incorporates a user interface design focus reduces costs in training and support requests after the product has launched. The more usable the application, the less training necessary by those who have to use it. If the application is built around users’ needs, they won’t have to call a help line for assistance. This cuts down on the need for help desk staff and online support models, ultimately saving you money.

Integration Capabilities: We need to keep in mind that we may need to integrate the application with other existing applications in an organization as a business requirement for ease of operation and/or automate the existing process.

Operation and Maintenance: We need to consider that the vendor has efficient support system in place to provide support for all requests, queries and issues raised by end users and what is the turnaround time with resolution. We need to check the cost factors to fix the things with configurations, adhoc requests which will come during operation, Audit support during regulatory inspections
Migration Capabilities: To move the existing legacy data into new system is not an easy task. There are many challenges if both source and target systems are not same. We need to check the capabilities of vendor and system to migrate the legacy data into new system without losing data.
Conclusion: If we take necessary steps while selecting the right computer system(s) or software, it improves productivity and reduces the maintenance cost and overall it saves time and money for organizations. If not, it always increases the dissatisfaction with end users which decreases the productivity and need to spend more money to customize the product, train the resources and to comply with regulations. Even sometimes we need to look for new systems within a short span of time, which will incur more financial burden to the organization

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