Quality

The IPS QCORe team can establish a Quality Management System, transition your QMS from pre-clinical to clinical and then manufacturing. This includes developing Quality manuals and Quality procedures. IPS can review and choose the right QMS application, perform internal and mock-regulatory agency audits and develop risk-assessments related to Quality, including facility, process and QMS RAs.

When QC procedures are not developed to address both the procedure subject and company approach, laboratory operations may be inefficient or even not compliant. Poorly developed methods can lead to delays in product releases and ultimately, product launches.

Compliance

There are three common struggles or concerns we see often with our clients:

Adoption of new and emerging technologies

This fear or concern is one of the first items that we address by having a complete understanding of how the technology can support the regulatory requirements posed by agencies. The QCORe team can advise you when technology poses a challenge or is of high risk and offers solutions to these issues.

Data

The underlying foundation to any decision made is data. Data can be recorded, observed, or witnessed, and can be an input or output of a process. Many of our clients overlook data or misunderstand their data. We at QCORe emphasize the importance of understanding, managing and maintaining one’s data and we can ensure that you understand the data related to your system and its impact on your operations.

Changes in Approach – CSA vs CSV

Depending on the complexity of a system, the traditional CSV approach often requires extensive documentation, focused formalized testing, and can be costly. Because of these factors, many organizations were slow to adopt new and emerging technologies and often delayed CSV projects due to resource constraints. In 2022 the FDA published its guidance on Computer Software Assurance (CSA) which changed the fundamental approach to validation of computerized systems and software. The QCORe team can educate you on its benefits and how to implement CSA practices into your validation approach to reduce costs and lower the implementation times of new technologies while maintaining a compliant, controlled system.

Operational Readiness

Operational readiness is essential to ensuring that all critical components: people, processes, technology, and compliance are fully prepared before execution begins. It minimizes disruptions, enhances efficiency, and accelerates time-to-market by proactively addressing potential risks and aligning resources.

In industries like biotech, operational readiness is crucial for regulatory compliance, manufacturing scalability, and quality assurance, helping organizations avoid costly delays and maintain high standards. A structured readiness framework fosters continuous improvement, optimizes resource allocation, and strengthens stakeholder confidence, making it a key driver of long-term success.

It's essential for staying competitive and responsive in the rapidly evolving industry.

Our experts have the industry experience across all facets of a project life cycle. We have the true experience to look at your goals holistically and fit your current strategies to future goals.