Manage, measure and meet your FDA GXP compliance needs with our sustainable and reliable software.

02_FDA GXP Compiance

The Challenges

  • FDA GXP standards are constantly shifting as quality control regulators continue to refine compliance mandates with each iteration of medical device technology.
  • Traditionally, in-house developed systems, standalone applications and manual paper-based processes have been used to manage quality and compliance at the departmental level. Such systems and processes lack a broad enterprise reach, are unable to scale effectively, raise the cost of compliance and increase the risk of non-compliance with FDA’s GXP regulations.
  • Companies in pharmaceutical, biotechnology or medical devices industries are constantly pushing the boundary of innovation to develop new products. In addition, the industry is constantly being challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements.

Our Solution

360factors offers a Life Science regulatory risk and compliance management software platform and advisory services to provide a sustainable and reliable method to manage your FDA GXP regulations through a simple yet effective regulatory risk and change management model and methodology.

We offer two unique solutions:

Option 1

Predict360 Managed Services

In managed services, you pay a flat fee to license the software along with our services to provide your organization with a quality software solution. By adopting a proactive, holistic approach, we help guide the whole company toward a culture of compliance and turn the resolution of FDA GXP issues into a source of competitive advantage.

Option 2

You can secure advisory services on a short and long term project basis. Speaking with our industry experts will give you the guidance you need to ensure your company’s efficient FDA GXP management.

Our experts follow a consistent Regulatory Risk and Compliance Management methodology.

  • Regulations drive the “Why” – why does an organization need to comply?
  • Once we understand the “why”, that leads to the “What” – what are the controls and what are the risk levels?
  • Once we identify the risk levels, this helps us prioritize which risks need to be addressed, leading us to the “How”.

Regulatory Change Management Methodology

  • The “How” entails defining a clear end-to-end process on how to mitigate risk and achieve compliance.
  • Once the process is defined, the next step is to identify the point of compliance which is the “Where” – typically a branch office.
  • Once the point of compliance is defined, the last step in the process is to identify the “Who” – who is responsible and who is accountable for actions and approvals?

Our Software

Our advisers and experts use Predict360, a regulatory risk and compliance software to streamline advisory services as a competitive differentiator. It vertically integrates all modules which allows organizations to manage their compliance programs based on federal and state regulations through a single platform.

  • A risk-based approach that is proactively integrated to meet FDA GXP regulations.
  • Automates the management of quality and compliance for an enterprise-wide reach to lower the overall cost of compliance and reduce the risk of noncompliance with FDA regulations and creating an environment that proactively manages quality issues.
  • Ensures that policies and procedures are updated based on the latest FDA standards to assure the safety and quality of products being produced by the company. It also allows better document control and tracking.