In this special blog series, ERP Software & FDA Compliance, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.
It used to be that manufacturers in FDA-regulated industries could get by handling approvals the old-fashioned way – with a stack of papers awaiting signature in an executive’s office. But as both production and commerce have globalized, signers are not at their desks as often as they used to be. And what were once sporadic approvals have multiplied as the frequency of on-demand production and smaller batches has increased.
Today’s most competitive manufacturers know that the ability to obtain digital approvals through electronic signatures (eSignatures) is a critical component of effectively doing business in a regulated industry. Here are three reasons why eSignatures are a must-have for your ERP system.
Approvals are critical to maintaining momentum throughout the manufacturing process. By doing away with paper-based approvals and enabling eSignatures in your ERP system, documents get signed faster. Not only that, sign-offs can happen anywhere, anytime and on any device using a mobile, cloud-enabled ERP system. This ensures that time-sensitive approvals from internal and external signers can be obtained from any corner of the globe.
When dealing with physical folders, there is an increased risk that somewhere along the way a dotted line will be missed and a sign-off will be overlooked. There is no longer a need to spend hours scouring papers to double-check your work. By using an ERP system to obtain signature approvals, manufacturers benefit from built-in controls that help ensure all steps are completed in the review and approval process. In addition, using a cloud-enabled ERP system makes it easier for stakeholders to review the status and details of each document. This not only reduces the risk of an error being made but simplifies the process of correction if an error is found.
Managing documentation and related approvals is a critical responsibility for any manufacturer working in an FDA-regulated industry. These documents comprise electronic batch records, recall notifications, incident and adverse event reporting, safety inspections and more.
Using an ERP system with eSignature capabilities supports secure and compliant electronic recordkeeping throughout the product lifecycle, from creation of the digital records through modification, storage and submission to the FDA. An ERP system also automatically captures contextual information such as the printed name of the signor, a date and time stamp and the meaning associated with the signature. With such robust data stored with each document, your organization is capable of showing what took place during the document review process – something that is essential to not only regulatory audits but also effective business operations.