Software development in the biotech / pharmaceutical field is subject to stringent regulatory controls. These controls, determined and enforced by regulatory bodies such as the Food and Drug Administration (FDA), specify key aspects of software development, testing, and functionality to ensure that these systems are both reliable and trustworthy.
Ndex’s combination of experience in application development and experience with FDA regulated business areas put us in a unique position to design, develop and implement technology solutions in these environments.
Regulatory compliant systems include design elements that specifically address mandated requirements such as activity auditing, electronic signatures, and role-based security. Some of these functions are difficult (or sometimes impossible) to integrate into existing designs; they must be part of the original architecture. Ndex thoroughly understands these technical constraints and designs compliant systems from the ground up. Critical elements are deeply embedded in the design to support validation and compliance from the initial implementation through the entire systems life cycle. And our proven project management and development methodologies deliver your compliant system on time and on budget.
