FDA Compliance Software

Solution & Benefits

ProcessGene™ FDA Software – Introduction

The ProcessGene™ GRC software suite provides a complete solution for FDA compliance. The FDA software is implemented within days, immediately creating compliance visibility and centralized control.

The FDA software establishes an automated workflow that reduces the time and cost of compliance enforcement and eliminates manual labor, maintenance of multiple excel spreadsheets, etc. ProcessGene™’s FDA software is designed for multi-subsidiary organizations, based on our Multi-Org technology.

ProcessGene is acknowledged worldwide as a leading provider of Business Process Management (BPM) software solutions (see Gartner’s report on ProcessGene).

FDA Compliance in a Changing Business Environment

In today’s highly regulated environment, enterprises are increasingly strained by regulatory compliance concerns, while at the same time having to promote the ongoing conduct of business. Executive officers are specifically required to demonstrate capabilities for effective regulatory compliance, and to ensure corporate transparency and visibility into the business.

ProcessGene™ GRC software provides a complete solution for FDA compliance. The FDA software is implemented within days, and uses automation to reduce the time and cost of compliance enforcement.

Compliance Challenge

The Food and Drug Administration regulation (also known as “FDA”, “USFDA”, “Healthcare Regulatory Compliance”) was introduced by the USA Food and Drug Administration, and has been continually maintained and updated to reflect the dynamic changes in business environment. The Food and Drug Administration regulation is aimed at protecting and assuring the quality of public health and safety. FDA applies to All companies in the following domains: food, cosmetics, tobacco products, medical devices, drugs, animal and veterinary, vaccines, biological products, and radiation emitting products.

Ensuring compliance with the FDA regulation is an important organizational task, which requires ongoing management of compliance data. The compliance process is continuous and needs to be repeated periodically and closely monitored. Managing officers are personally responsible to maintain the FDA compliance, and this responsibility requires significant management attention and allocation of time and effort. Beyond self assessments or assessments of compensated third parties (such as accounting auditors or regulation consultants), the organization may also confront other external audits, such as FDA, that show little if any tolerance to deficiencies. The ProcessGene credo in this matter is that objective compliance data, maintained by the organization itself, has much higher value than opinions of compensated third parties. We also believe that only an ongoing, continuous process can ensure actual compliance and audit clearance.

Compliance Challenge for Multi-Subsidiary Organizations

Multi-subsidiary organizations are confronting even more complex compliance challenges, due to differences between the business processes and operational characteristics of subsidiaries. Hence, the management and communication of FDA compliance in a multi-subsidiary environment becomes an extremely complex task when managed manually or by tools that are not specifically designed for Multi-Org operations.

FDA Compliance with the ProcessGene™ GRC Software Suite: Solution & Benefits

ProcessGene™ GRC software provides a complete solution for FDA compliance. Our Multi-Org software solution automates the FDA compliance lifecycle and offers the following benefits:

Very fast implementation, the FDA software is up and running within days
The FDA software is based on Multi-Org technology, designed for FDA compliance in multi-subsidiary organizations
The FDA software features full automation of the FDA compliance process using the ProcessGene™ BPM workflow engine, making it the most powerful system in the industry – yet the most intuitive and user friendly
The FDA software features central cockpit with dashboards for data analysis and diagnostics- showing quantitative FDA compliance fulfillment levels
The FDA software features easy and fast access to objective evidence used for external audits
The FDA software features direct connectivity to ERP systems (e.g. SAP / Oracle) and ability to extract and process data in real time, and run automated tests
The FDA software covers not only FDA compliance but also hundreds of other regulations and frameworks – all within the same framework
The most seasoned and comprehensive SaaS (Software as a Service) solution in the GRC domain (see Gartner’s report on ProcessGene)
The FDA software improves the quality of FDA internal audits and self-assessments
Leverage the quality and safety of products
Prevent product waste and production inefficiencies

ProcessGene™ “Multi-Org” Technology

ProcessGene™ has been a pioneer and global leader in Multi-Org technology. During the past decade we have mastered a unique expertise in providing software solutions to multi-subsidiary organizations worldwide (see Gartner’s report on ProcessGene). Our FDA compliance software has been specifically designed for multi-subsidiary organizations and it features the most comprehensive solution for complex, distributed compliance challenges. Read more about ProcessGene Multi-Org technology.