ERP FDA Compliance: eSignatures and Obtaining Approval

Share this blog
   

Learn about the advantages of using an ERP Software in an FDA-regulated industry. In this blog series, we will discuss issues ranging from organizing mission-critical documents to vendor management, as well as how an ERP system can help keep manufacturers in compliance and product timelines in place.

Manufacturing executives in FDA-regulated industries used to spend hours at their desks with stacks of papers awaiting their signatures. This practice can now be a thing of the past. Since executives are no longer sitting behind a desk daily, and the periodic approvals have now multiplied in frequency, eSignatures are a critical component of successfully doing business in a regulated industry.  

On-demand and small batches have increased, and today, most competitive manufacturers know that the ability to obtain a digital approval is essential in a regulated industry. As both production and commerce are continuing to increase, eSignatures are a must for your ERP system.eSignatures and Obtaining Approval

Enhanced Efficiency

By enabling eSignatures in your ERP system and doing away with paper-based approvals, documents maintain their momentum thought the manufacturing process.  Approvals are critical and eSignatures can happen anywhere, anytime and on any device using a mobile, cloud-enabled ERP system. Approvals from internal and external signers can be obtained from any corner of the globe to ensure time-sensitive sign-offs are done efficiently and with ease.

Reduced Risk

Using physical folders increases the risk that somewhere along the way a sign-off will be overlooked. Manufacturers benefit from using the

“The efficient implementation of Infor CloudSuite by The Copley Consulting Group will allow us to scale operations rapidly,” said Don Spence, president and CEO, Ebb Therapeutics. “With this FDA-validated enterprise system in place, we will be able to more effectively meet the clinical needs of patients and their treating physicians with our novel, drug-free treatment option for insomnia.”

built-in controls in an ERP system to ensure all steps of obtaining signature approvals are completed in the review and approval process. In addition, when using a cloud-enabled ERP system, reviewing the status and details of each document can be done easily by your stakeholders. This not only reduces the risk of an error being made but simplifies the process of correction if an error is found.

Fortified Compliance

In an FDA-regulated industry, managing documentation and related approval is a critical responsibility for any manufacturer. The documentation comprises electronic batch records, recall notifications, incident and adverse event reporting, safety inspections and more.

Submissions to the FDA are streamlined when using an ERP system with eSignuature capabilities that supports secure and compliant regulations throughout the product lifecycle, from creation of the digital record to modification. Automatically capture the contextual information such as the printed name of the signor, a date and time stamp and the meaning associated with the signature. Your organization will be capable of showing what took place during the review process with the data stored from each document in the ERP system – something that is essential in effective business operations and regulatory audits.

 

 

ERP & FDA Compliance

 


Filed Under: Blog, FDA Validated