There is never a one size fits all solution and the same goes for document management system or DMS, especially for the Pharma domain. Document management is a bit tricky in Pharmaceuticals as the industry needs to adhere to strict compliance and regulatory standards. At one side you need collaborative efforts for fast to market release; on the other, the security should be top-notch. If you are planning to upgrade your existing DMS or investing in a new one. It is only wise if you make a note of the following features:
Many pharmaceutical companies still have their reservations about cloud document management systems.
Cloud-based: Look for a document management system which is cloud-based. Workplaces have evolved through the years and today we are in the era which is all about social collaboration, agile processes, real-time updates, and rising tech trends. It is imperative our systems comply with changing times. History speaks volumes about companies which failed to innovate and where they are now. Cloud is the future and very few companies have the capacity to make an upfront infrastructure investment. I know you may have your reservations, but cloud security today offers stability, reliability and multiple layers of security, and it’s getting better.
Tamperproof: This is one of the most essential features to look in document management system for pharmaceuticals. With the introduction of blockchain in DMS, you can check for authenticity of electronically signed documents. In blockchain-based DMS, even the slightest change like adding an extra space does not go unnoticed. So, not only are your documents tamper-proof, you get an audit trail too. Validation is important and what better way then blockchain.
Pre-defined templates: There are certain fixed regulatory standards when it comes to document submission. While they may not come as an out of the box feature with your document management system, make sure you invest to get all the necessary templates. Mistakes with ANDA( Abbreviated New Drug Application) submissions are more common than you think. Such document templates with proper document review workflow will ensure documents are created, reviewed, and approved on the first cut.
Automated workflows: This is a very basic yet important feature so I thought I will include it in the list. Accelerate time to market with automated document approval workflows. You can either go for out of the box workflows or create custom ones depending on your requirements. No more waiting for internal document approvals. Every time a document is created it is automatically going into the workflow and will notify the concerned person or group of people. Hassle-free and faster approvals.
Cross-functional team collaboration: The document management system should offer convenient collaboration for teams to work on documents seamlessly. Cloud technology today offers such functionality through which you can give secure access to external stakeholders without compromising security. Just imagine how much benefit will real-time collaboration provide. As organization globally are pushing towards a one-team approach such systems will help break silos and help develop better products faster.
Integration: Lastly, you should be able to use your document management system seamlessly with common everyday tools like emails, word documents or drive. E-mails within the system should be automatically captured and linked to the relevant document library. There should also be the option to easily drag-and-drop documents without you exiting the current application.
Flabby document management continues to be one of the top concerns of pharma manufacturing slowdown. These are among the few things that will mitigate mistakes and help manage documents better.
We at i2e Consulting have been providing document management solution to pharmaceuticals for more than a decade now. Our SharePoint document management system is available both on-premise and cloud. It may be customized to fit into your organizational workflow. Let us know if you need upgrading. We are happy to help.