Case Study

Helping a leading manufacturer of infant formula adapt to COVID-19

July 28, 2020
3 Minute Read

A leading Global manufacturer of infant formula came to DocQ looking not only to streamline their approval processes, but also to adapt to the “social-distancing” guidelines that came with the emergence of COVID-19.

This company produces consumer goods that end up on the shelves of supermarkets and grocery stores alike. This makes them subject to be audited by the FDA, a federal agency of the United States Department of Health and Human Services. Anytime this company produces a label to be affixed onto one of their products they are  required by law to have such labels be approved internally by several departments: Packaging, Medical, Regulatory and Legal.

Prior to DocQ and in the pre-COVID19 world, this DocQ customer would have a weekly face-to-face meeting to review physically printed copies of would-be labels. Representatives from each department would provide a wet-signature signifying their approval of those labels. These meetings were also used as a forum to voice concerns regarding any shortcomings that might need to be rectified in order to comply with all FDA rules and regulations.

However, the advent of “social-distancing” and “stay-at-home” orders to curb the COVID19 pandemic makes weekly face-to-face meetings impossible. It also makes the process of obtaining wet signatures on physical prints extremely inefficient. While meetings could be held via video-conferencing, the lack of physical meetings makes maintaining audit-trails of actions, concerns and resolutions very difficult to implement as well.

This customer of ours decided to adopt DocQ in order to solve these new set of challenges they face and streamline their digital workflows. DocQ enables them to  maintain the same workflow process of reviewing and approving these labels digitally. The built-in audit-trails enable them to have all involved parties providing relevant feedback and running the labels through several versions easily as well.

With DocQ’s unique parallel approval feature, a label can even be sent digitally for review and approval to each department representative at the same time. Meaning, one department does not have to wait for the other to review and approve a label.

Additionally, DocQ also provides an optional way for a department that is satisfied with a label to skip an additional review/approval cycle in case a new version of the document is created due to the remarks of only one other department. This streamlines the workflow process even further. For example, if the Packaging department were to approve the label in the current revision, but the Legal department rejected the current revision, then the Packaging department would not be required to review the same label as the new and subsequent revisions would only be pertinent to the Legal department.

DocQ has also helped this customer resolve the wet signature issue via integrated eSignatures and digital certificates to make documents tamper proof.

Using DocQ not only solved the company’s need to distribute labels for review and approval by digital means (because of COVID-19), but DocQ also provided a more streamlined approach that optimizes the review and approval process of FDA audited labels, while maintaining all required audit standards.

Parallel approval step process workflow

With DocQ’s unique parallel approval feature, a label can be sent digitally for review and approval to each department representative at the same time. Meaning, one department does not have to wait for the other to review and approve a label.

Additionally, DocQ provides a way for a department that has approved a label previously to bypass a review and approval cycle of the same label with a different revision if they so choose. This streamlines the workflow process even further, because if the Packaging department were to approve the label in the current revision, but the Legal department rejected the current revision, Packaging department would not be required to review the same label as the new and subsequent revisions would only be pertinent to the Legal department.

In fact, not only has DocQ solved a way to distribute labels for review and approval by digital means (because of COVID-19), DocQ also provided a more streamlined approach that optimizes the review and approval process of FDA audited labels.

written by

DocQ Team

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