One of the business values FileHold software provides organizations is the ability to securely store information and, more importantly, be able to quickly retrieve it when needed. We have many customers who tell us that FileHold has helped to make them compliant with government regulations and allows them to produce audit information when required.
The concern about regulatory scrutiny by global organizations was confirmed in research produced by Protiviti a global business consulting and internal audit firm composed of experts specializing in risk, advisory and transaction services. They provide a unique perspective on a wide range of critical business issues for clients in the Americas, Asia-Pacific, Europe and the Middle East.
Protiviti partnered with North Carolina’s State University’s ERM Initiative to conduct Executive Perspectives on Top Risks Survey and obtained the views of more than 275 board members and C-suite executives about risks that are likely to affect their organization in 2015.
Overall, the survey findings suggest that while the business environment in 2015 will be somewhat less risky than in the previous two years, most of the business leaders surveyed indicated that they are more likely to invest in additional risk management resources in 2015.
Key Findings: Regulatory changes and heightened regulatory scrutiny may affect the manner of production or delivery of products or services
Topping the list of risks for the third consecutive year is the concern that regulatory changes and heightened regulatory scrutiny may affect the manner in which an organization’s products and services will be produced or delivered. This suggests companies continue to have significant anxiety that regulatory challenges may affect their strategic direction. The stakes are high since, without effective management of regulatory risks, organizations are reactive, at best, and noncompliant, at worst, with all of the attendant consequences.
Companies of all sizes need to determine how regulatory requirements might have an impact on their strategic business objectives.
FileHold software provides an easy to use but highly secure way for organizations to protect their intellectual property and remain in compliance with the many and varying regulations for document and record retention. Most importantly information that is needed to satisfy regulatory scrutiny can be highly organized and produced upon demand using powerful search mechanisms. Read the full FileHold case study on one company's path to the US FDA 21 CFR Part 11 validation. You can also read an article on how FileHold software offers features that will help companies comply with 21 CRF Part 11.