Document Management: Communication with Regulators 

Sparta Systems

Document management technology can be used by manufacturers in regulated industries, such as Life Sciences, to aid their communication with regulators in several ways. 

• Compliance: The use of document management technology can help manufacturers in regulated industries meet regulatory compliance by automating the document management process, making it easy to create, review, approve and store documents. This can help to reduce the risk of errors in the manufacturing process and ensure that all necessary documents are readily available for review by regulators. 

• Electronic submission: Many regulators, such as the FDA, now accept electronic submission of documents. Document management technology can help manufacturers prepare and submit these documents electronically, making it easier to submit the documents in a timely manner. 
• Auditing and tracking: Document management technology can also help manufacturers to track and audit the changes made to a document. This can be useful during a regulatory review as it allows manufacturers to demonstrate that documents have been reviewed and approved by the appropriate personnel and that any changes made have been properly documented. 
• Secure storage: In regulated industries like pharmaceuticals and medical devices, manufacturers need to ensure that sensitive information is stored securely. Document management technology can help manufacturers to store documents securely, protecting sensitive information from unauthorized access. 
• Reporting: Document management technology can also help manufacturers to generate reports that can be shared with regulators. Reports can include information on the approval status of documents, changes made to documents and compliance with regulations. 

Overall, document management technology can help manufacturers in regulated industries manage and control their documents more effectively, making it easier to comply with regulations and demonstrate compliance to regulators during inspections and audits.