Mobile Document Access, Review and Approval Combine to Remove the Regulatory Bottleneck

The work environment for regulatory decision makers has changed dramatically in recent years, requiring them to respond rapidly to submission documents and remove any potential roadblocks to bringing products to market.

In this environment, regulatory staff must be able to, in a secure way, access documents remotely from mobile devices quickly and easily. Typically, in such situations, they need to view a document for approval rather than for in-depth review. That means when they are out of the office, regulatory decision makers need access to just the right amount of information in a format that’s readable on their mobile devices.

Given that decisions need to be made on the go and often remotely, regulatory staff members need solutions that don’t tether them to a more cumbersome device while still being able to perform key business processes quickly and accurately. This means they need to access key data, documents and notifications — all at the press of a button.

Mobile in the field

Access via mobile devices must still contain the same level of enforceable security as more traditional methods, whether a work computer or a laptop. That means ensuring security measures that protect the data and the routes for accessing that data, including data-access tracking and policy enforcement.

There are multiple scenarios where quick document access from a mobile device might be required:

Scenario 1: A regulatory affairs manager is at her daughter’s soccer match when she receives notification that a document needs her attention and approval. It’s hardly the right environment to pull out a laptop, but she also doesn’t want to hold up proceedings. Having the right capabilities allows her to perform a quick review and grant approval on her mobile device.

The priority for the regulatory affairs manager is to not be a bottleneck in the document approval process. That’s why being able to manage the approval process quickly and easily — without missing her daughter’s match — is a game changer.

Scenario 2: An operator in the production area needs quick access to the latest approved standard operating procedure (SOP) for the step in the manufacturing chain that he is about to carry out using a certain machine.

When he has finally located the binder where the manufacturing records are kept, he notices that this SOP has reached its expiration date and is no longer effective and, due to human error, hasn’t been replaced with the new one.

By now a lot of valuable time has already been lost, and production is standing still, so he needs to act fast. He decides to quickly try to find one of the administrators with the correct printing rights so he can get a new controlled print to use and get production going again.

In this situation, as with many others, having mobile capabilities in a well-constructed document management solution would be a huge help.

If a QR code is attached to the equipment on which the operator performs the job, along with having the same code assigned to the SOP´s routines, forms or other necessary documentation, all that is required is to scan the QR code on that equipment with a mobile device, and the correct documentation will immediately be pulled up on the screen.

This is especially helpful during an onsite inspection, where you can show that you have made your production even more compliant by reducing the risk of human errors and ensuring that you are always using the right documentation

It will also make you more LEAN , since you will waste less time for each individual step while reducing production downtime. Depending on how far you want to take your steps in being LEAN, you potentially could reduce, or even eliminate, the amount of paperwork currently required.

DXC Technology has the solutions and expertise to simplify and secure access through mobile.  Learn more about FirstDoc Mobile by visiting the DXC booth 412 at DIA 2017, where we’ll be presenting our latest FirstDoc Mobile capabilities.


Sharad Khusal is global head of Life Sciences Software and Solutions Advisors at DXC and Steven  Gruber is a product manager at DXC.

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