ERP Software Compliance for Regulatory Standards such as SOX, FDA, and ISO using Microsoft Dynamics NAV

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Let’s face it, whether you’re a publicly or privately held company today, it’s quite likely that you will need to comply with at least one regulatory agency in order to meet your customers’ needs. Whether it’s ISO, FDA, SOX (Sarbanes Oxley), DOD, etc., you need a system that is robust enough to provide the necessary support features without slowing you down. Microsoft Dynamics NAV (aka Navision) is that system.

So what do you need from an ERP system to provide compliance? I hate to say this, but it depends. It depends on the agency and quite often on your own procedures. Your Financial, Operations, and/or Quality Groups will have to make those determinations depending on your Tier Level (size) and the standards you are planning to comply with. The good news is that most of them have some commonality, so we will cover these here, but please feel free to contact us if you have any questions or additional requirements.

Security – a robust security system is essential. NAV’s role based security really shines here and is easy to maintain. It will allow you to keep your roles clearly defined for even the most stringent SOX auditor.

Change Log – You get to decide what you want to log so that you can fulfill your organization’s audit trail requirements without bogging the system down with unnecessary information. Not only can you meet external requirements, but you can finally find out who changed the customer’s order after you printed the acknowledgement.

XBRL – XBRL can be an important tool in an organization’s efforts to become compliant with the Sarbanes-Oxley Act. It also helps ensure that companies can easily share data with auditors, which can aid in Section 404 compliance as well as create reports simply across systems and even post on the Internet, further informing the public of the current state and changes of the organization, aiding in Section 409 compliance.

Serial and/or Lot Number Tracking – Whether you’re providing traceability for food and drug manufacturing to meet Title 21 CFR Part 11 Compliance, DOD contracts, or any other application where you need to know what was used in the manufacture of a specific item or if you just need to know the serial number as it goes out the door, NAV ERP will do it for you. And you can have it all, Lot and Serial number tracking at the same time, if that’s what you need.

Document Approval – Do you want to speed up your audits? Electronic document approvals can assist you there. No more digging in the storage room for the hard copy files. No more trying to explain lost or misfiled items.

Document Storage – Keep the hard copy files online, so you can pull them up whenever you need them without having to search the files. Whether it’s a vendor invoice, drawing, correspondence, or other documentation, you can have it with a mouse click.

Quality Assurance – Keep track of your inspection records online and have them readily available for reporting and other uses.

Bill of Material and Routing Revision/Version Control – NAV’s revision/version control for BOMs and Routings provides a complete revision history for your Engineering documents. In addition, each production order retains a history of actual material issued, machine usage, etc. as needed for your procedures. You control the level of information you need.

IT Change Control – Do you need help documenting the appropriate procedures to test programming modifications for compliance with FDA, SOX, and other requirements. We’ll be happy to help you develop these to meet your requirements. In addition, Microsoft Dynamics NAV flags all modified code to make it easier to ensure that all documentation has been maintained.

These are just a few of the areas that Microsoft Dynamics NAV can help you bring into compliance or provide better controls if needed. So whether you require compliance, help with process improvement, or just a nimble system with great functionality, we can help you.

Come and visit the Clients First Business Solutions BLOG, a great source for free information, and learn something new. Then contact Clients First Business Solutions, comment below, or click on “Ask the Author” to let us know what helped you or ask a question you may want answered.

By Karen Wevick, Clients First Business Solutions, Mississippi and National Microsoft Dynamics Gold Partner also located in Alabama (AL), Tennessee (TN), New Jersey (NJ), New York (NY), Minnesota (MN), Texas (TX), and California (CA)

1 thought on “ERP Software Compliance for Regulatory Standards such as SOX, FDA, and ISO using Microsoft Dynamics NAV”

  1. We are working with a client that use a combination of our software with Microsoft's Dynamics. The question came up as to whether our software connected to MD had to be certified for compliance.

    They do not use any compliance software with their MD because they feel it is already compliant.

    My question is: Does any software have a certification or is it just that the software should assist them in reporting and auditing for their own compliance certification?

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