Since 1998, Business Intelligence Solutions has been helping our clients accelerate innovation and streamline compliance. As a trusted business partner to over 100 FDA regulated companies and healthcare organizations, we have conducted more than 500 successful engagements through strategic partnerships that provide our customers with additional resources and value.

Process Validation Services Business Intelligence Solutions regulatory software validation services offer the distinct benefits:

Evaluating regulatory compliance

Identifying associated risk factors

Enhancing productivity through a reduction in application development and implementation time

Capitalizing on the investment in software systems and benchmarking return on equity

Improving schedule visibility, assuring milestone achievement, and project success

Providing a qualified, third-party analysis of software systems

In order to facilitate the process validation and testing of software systems in the most time-efficient and
cost-effective manner possible, we follow a proven process of:

Conducting an assessment of critical needs

Drafting project specifications for client approval

Setting finite objectives for each phase of the testing process

Developing a matrix of software testing scripts tailored to meet those objectives

Executing the appropriate software testing mechanisms utilizing commercial and proprietary tools

Reporting the results of our comprehensive testing, including completeness metrics

Repeating testing to accommodate changes resulting from ongoing upgrades and system maintenance

This process validation and testing process not only focuses on software systems, but also evaluates the training and organization of the client’s personnel and the effectiveness of their operating procedures. While technical considerations are an integral part of the regulatory software validation process, our professionals also offer the value-added benefit of viewing systems from a broad-based business perspective. This means that our results-oriented process not only ensures compliance and functionality, but also complements and reinforces the client’s marketing programs and new business initiatives and responds competitively to the needs of their customers.
Our client approach allows you to immediately access the technology resources and talent you need to run your project, without having to create a stand-alone unit. Our capabilities add leverage to your technology investments and reduce cost to create sustainability in a climate of reduced resources.

Approach to Process Validation

Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

Process validation involves a series of activities taking place over the lifecycle of the product and process.

Process validation activities can be broken out in three stages.

Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

Information Technology Resources that Match Your Business Needs

Many companies lack the resources to cover all competencies along the application lifecycle. With on-demand access to skilled specialists, you can leave your application management queries to us and focus on your core competencies.
Our Application Skills on Demand is a single professional services contract that provides access to our project managers, business analysts, application technicians and other application management specialists.

Since 1998, Business Intelligence Solutions has been helping our clients accelerate innovation and streamline compliance. As a trusted business partner to over 100 FDA regulated companies and healthcare organizations, we have conducted more than 500 successful engagements through strategic partnerships that provide our customers with additional resources and value.

We understand that your needs are critical. You require solutions that help you navigate new regulatory requirements and pursue business initiatives to expand into new markets competitively.



John is the author of this article on Root Cause Analysis. Find more information, about Root Cause Analysis here