How Document Management System Helps Pharmaceutical Companies Comply with Regulations?

How Document Management System Helps Pharmaceutical Companies Comply with Regulations?

The business of making life-saving drugs is not just guts & glory, it also involves an insurmountable amount of paperwork. From conducting drug trials to storing research information to maintaining funding records, pharmaceutical companies have to deal with documents at every step. Maintaining, storing, tracking, & securing these documents are essential to comply with 21 CFR Part 11 and ensure transparency in the research & funding processes. And that is why more & more pharmaceutical companies are investing in document management software.
A pharmaceutical document management software comes with an array of advanced features like custom workflow automation, automated indexing, built-in scanning & printing support, two-factor authentication & more. A document management software for pharmaceutical companies accelerates document processes while ensuring that the data is protected from all types of digital & real-world threats.

Here is how document management systems helps pharmaceutical companies comply with regulations:

Image Pharmaceutical companies

Assists with Audits:

21 CRF Part 11 states that every pharmaceutical organization needs to maintain a certain standard of document security & a retrievable document trail for audits. A pharmaceutical document management system helps you comply with these regulations by providing clearly-defined document organization & search features that allow you to retrieve documents much faster during audits, as well as features such as access control, which let you track document activity & protect them from unauthorized access.
Document management systems also provide features such as document linking & stacks that benefit the auditors by providing them with a single point of access to documents related to any specific drug, project, employee, etc, making the audit process that much easier for auditors & pharmaceutical organizations alike.

Automates Repetitive Tasks:

Documentation involves plenty of repetitive tasks like importing & segregating new documents into respective groups, extracting metadata from scanned & uploaded documents, creating versions of documents once they have been modified, taking backups & more. A document management system is designed to automate these repetitive tasks, which saves time and boosts productivity & efficiency across the entire organization.
Here are some document management features & how they automate day-to-day pharmaceutical document processes:
Watch Folders: Automatically imports new documents from ‘Watched’ folders on the computer, to a location on the document management system.
Destination Profiles: A collection of information about the document’s type, stack & folder, which automatically places them in the desired group.
Automated Indexing: Automatically extracts metadata from every scanned & uploaded document.
Document Versioning: Creates & tracks new versions of documents every time they are modified.
Automatic Backups: Automatically backs up documents on secure servers for safekeeping.

Provides Custom Workflow Automation:

On-time & correct document approvals are an integral part of pharmaceutical organizations, baring which drug manufacturers can find it difficult to file for patents or submit research reports within the allotted period. Document approvals can be delayed due to a multitude of reasons, ranging from lack of digital infrastructure to a multi-software setup where one software caters to just one type of document (Microsoft Excel for .xls files).
A pharmaceutical document management system replicates the entire document approval (workflow) process with ease. It lets you multiple documents, run multiple approvals at the same time, choose the number of approvers, track & notify users about the approval process and pause, edit or delete pending approvals within the system itself.

Increases Data Security:

Controlling access to documents is just one of the ways pharmaceutical document management systems can secure documents. For example, 21 CRF Part 11 states that digital signatures can be biometric or electronic, so long as they are stored securely. The regulation also states that pharmaceutical companies (in the USA) need to notify the FDA if & when they decide to use e-signatures on their documents. A pharmaceutical DMS provides a completely secure & customizable e-signature facility, which allows users to create or upload their own e-signatures and apply them to any document they want.
Pharmaceutical document management systems also provide other security features like 128-bit & 256-bit document encryption, hierarchical security groups, event logging & more, which are essential to controlling or restricting access to sensitive documents & information.

Improves Document Retention:

Protecting important documents from accidentally getting deleted or deleting old unwanted documents is an important part of document management at pharmaceutical companies. Document management systems provide features that automate the entire document retention process of pharmaceutical companies.
Document Archival automatically moves important documents to the ‘Archive Database’ on a selected date. Once documents are archived, they cannot be modified or deleted without the management’s permission. Similarly, Expiry Date automatically deletes old documents on a specified date and moves them to the system’s Recycle Bin. Documents in the Recycle Bin can be retrieved within a previously set period.


GLOBODOX provides all the features & benefits mentioned above and is well known across the global pharmaceutical sector for its expertise. GLOBODOX’s elite clientele includes thousands of satisfied customers spread across more than 60 countries. GLOBODOX is a cost-effective & user-friendly platform that has revolutionized document management for its users. Here are what some of our users have to say about us: Testimonials
To start your 30-day free trial, visit or write to us at [email protected]
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