Approval Workflow

An Approval Workflow is considered a path for the large amount of approvals that consists of a sequence of reviews done by different authorities who create and modify GMP-related (Good Manufacturing Practices) decisions and documents. This process includes the process of creation of different documents ranging from the master files to batch production steps. In many aspects this type of workflow is important as it may act as an additional risk control measure, ensuring that all decisions made in regard to the approval are legitimate and the process of the approval is done in accordance with the law (21 CFR Part 11 and EU Annex 11). 

Flaws in the design of workflows lead to the creation of obstacles in the entire process, push forward a swift decision making and lessen responsibility. The design of successfully framed workflow leads to the reduction of the processing time and improves the quality of information.  

What is Approval Workflow? 

In the industry where production is regulated, approvals can be found at every corner of the process behind an incoming material being delivered or a special material being weighed in or even a batch being released after reaching the permitted level after quality assurance tests or dealing with a case of a deviation due to temperature changes. 

Approval workflow is the official way of making decisions through the system. Each point gives information about the function of a person who signs it, what it means, what the procedure should be for escalation of the process and substituting someone and what documents should be signed by the person. The sequence of signing is determined by the rules so that the ones who create documents cannot give permission to others to deal with these papers. 

In today's environment, modern workflows will use a contextual and risk-based approach. The decision on how a record flows will depend on factors such as product type, geography, risk assessment, and severity of the change. The use of service level agreements (SLAs) and dashboards eliminates the possibility of the rules being ignored. 

Also, conditional branches make sure that changes which are high-profile have to go through steps such as validation and the involvement of regulatory affairs departments of the organizations and it will also make it easy for low-impact and routine changes to be implemented without going through many processes. 

With the implementation of this type of a workflow, it becomes easy to avoid some of the major issues that can occur in a workflow process including the making of a complex process which only results in waste of resources through unnecessary approvals from all departments. 

Regulations such as FDA 210/211 mandate that production and control documents are subject to evaluation and approval of quality unit. Regulation 21 CFR 820 applies to medical devices and demands similar detachment in reviewing, documenting and approving the processes, changes and records of batches/disposition. Regulations of Part 11 and Annex 11 supplement the previously discussed requirements with demands regarding computerized systems: separate identification of a user, valid workflows, secure record keeping, and data retention/readability.