Tags: Regulatory Submissions Workflow, Compliance, FDA, HIPAA, DPA, GDPR

Regulatory Submission Workflow

 

Regulatory bodies require documents from organizations and businesses under their control for verification of standardized procedures or products. These documents must be prepared according to a specific template and pattern; required to be submitted at a given time. This is the description of a regulatory submission.

The preparation process of these documents and the required material usually involves more than one department. The allocation of job responsibilities in order to meet the deadline for submission is quite tasking and tedious. This is why workflow is needed and essential. Regulatory Submission workflow, therefore, involves the sequential arrangement of responsibilities and tasks in order to meet the deadline for the submission of required documents and records to a regulatory body.

 

What Are the Components of this Workflow?

 

Right from draft to final product, here is an arrangement of the workflow involved in regulatory submission:

  • Assignment and Dispersal of Responsibilities

On getting the number of documents required for submission and the deadline for submission, the first step in the workflow is to assign responsibilities. It doesn't matter if it is an automated or manual system; dividing the workload is carried out first before any other thing. The departments required to provide specific information and those that are required to sort out the information and process are decided upon. Each individual knowing their assigned responsibilities begin processing and preparation. The order and arrangement of these responsibilities are usually presented in a spreadsheet.

  • Progress Tracking

On assignment, a deadline is given for the submission and tendering of work down. Progress tracking basically certifies that work done is carried out on time in order to meet up with the deadline.

  • Review and Editing

At the completion of each session, proofreading and follows after. A manager or expert, in a manual workflow system, handles this responsibility, editing the document and querying unclear records. If a redo is necessary, it will be decided upon at this point.

  • Compilation

Compiling every task and individual responsibility into one for submission and final touches are done to the record or document is finalized.

  • Submission and Feedback

Relating the regulatory submission through email or a post office is the last step. Notification of receipt will be sent to the organization from the regulatory body or recipient. Feedback can be given depending on the document in question and the process that needs to be verified.

 

Is A Workflow System Necessary For Regulatory Submission?

 

Yes. Determining how a regulatory submission is carried out through a workflow is quite necessary. Here are some vital reasons why;

  • Monitor Execution Of Task

Each department given specific tasks are adequately monitored and controlled. If each component has been broken down into assigned responsibilities, it is quite easy to find information needed and identify a problem if any arises.

  • Manage Time

Assigning responsibilities and allocating time will make effective time management.

  • Ensure Orderliness

The breakdown of jobs and responsibilities and tracking progress also puts every aspect of the workflow in order hence there is no confusion and unnecessary wasting of time. This orderliness is key to why workflow is crucial in a regulatory submission.

 

Regulatory Submission Automation with Activity Factory

 

Regulatory requirements have to be complied with by businesses in order to operate legally. This makes the Regulatory Submission Process tremendously important.  This process demands extensive collaboration among internal and external stakeholders and involves a lot of paperwork and bureaucracy.  

Activity Factory can expedite the regulatory submission process by automating Regulatory Submission from start to finish, ensuring consistent execution of the process,  accountability, and adherence to timelines


Activity Factory is a workflow automation tool that allows companies to build consistent and auditable compliance and operational workflows, ensuring that the right processes are followed at the right time while staying compliant.

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