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Conquer Big Pharma Regulatory Compliance by Automating Document Management

In the process of bringing new medicines to market, pharmaceutical companies generate thousands of documents that need to be recorded, reviewed, and managed correctly. With strict regulations in place to ensure that all medicines are efficient and safe, meeting Big Pharma regulatory compliance is essential.

Process automation technology can help pharmaceutical companies boost productivity and collaboration while meeting all their regulatory requirements.

Three stages of development

There are three stages that pharmaceutical companies must complete to bring a new medication to market:

  1. Preclinical stage
  2. Clinical stage
  3. Commercialization and post-market stage

Pharmaceutical companies need a solution that allows them to record, review, and manage documents throughout these stages. They need to ensure that this is done accurately and efficiently.

Preclinical stage

The research and development that goes into discovering new medicines at the preclinical phase is a long process – in many cases taking twenty years or more. The process can involve years of thorough scientific research and collaboration from chemists, pharmacologists, and biologists. At the end of this, a viable new medication is submitted to governmental and/or international authorities for review. Most notably, this includes the Food and Drug Administration (FDA), but also organizations like the European Medicines Agency (EMA) in the EU, for instance.

Document management plays a large role in formalizing all of the research.

One of the main reasons for the FDA to dismiss a submission for a new medicine is incorrect or incomplete documentation. Everything that is known about the new medicine has to be recorded to meet pharma regulatory compliance. Thousands of documents relating to the drug’s chemical structure and compounds, and its possible side effects are all included—that’s a lot of important information that must be documented correctly.

Why automate?

With workflow and process automation, organizations can ensure better regulatory compliance, fewer errors, and improved efficiency. Capabilities like advanced document generation allow for data to be pulled from multiple sources and automatically populate a templatized, compliant document – without the need for manual entry. Deep integrations with SharePoint, Office 365, Salesforce, Dropbox, Box and more allow organizations to store the generated information correctly in the right place, achieving end-to-end data capture.

Clinical stage

New medicines are tested on human subjects in the clinical trial phase. This is initially carried out on a small group, but that number can rise to include thousands of people by the end of the process. Strict documentation and review procedures are essential for tracking the results of these trials.

In the US, the clinical stage is a critical part of a new drug application (NDA), which can include anything from 100,000 to 500,000 pages of documentation. Organizations need a solution that can reliably manage all of this information—the sensitive nature of patient data needs to be protected too.

If left to manual processes, a single instance of human error can result in significant delays to a new drug getting to market. Also, a paper-based process can easily lead to important information being misplaced or destroyed.

It is also a time-consuming task for staff to ensure that all of this information makes it from the trials to the organization’s document management solution.

Why automate?

Responsive digital forms can help patients, clinicians and researchers quickly and easily record trial information on modern devices. These forms can be integrated automatically into intelligent workflows, so that information is always routed correctly and stored in compliance with pharma regulations. Modern forms are also much faster and intuitive to manage, automate and to fill out – ensuring everything is captured at the required time and to the required standards.

Commercialization and post-market stage

After successfully passing the NDA, pharma companies can begin to sell their new medication. But this doesn’t mean the organization can forego strict document management practices. Pharma regulatory compliance standards require records to be kept for a wide range of details, including consumer complaints, quality control records, adverse reactions, sales and more.

Why automate?

Automation can ensure that best practice in regulatory compliance is adhered to on a continuing basis. If new information – like if a customer reports adverse reactions to the medication – can quickly and systematically be recorded and the correct actions taken. Notifications can be automatically set up so that issues like this are escalated to the people responsible for acting.

Automate pharma regulatory compliance

Outdated technology and inefficient processes are behind many document management pitfalls, causing delays to the approval of new medicines. The cost of these can be severe.

The cost of bringing a new medicine to market is estimated at $2.7 billion – and with a reported 9 out of 10 medicines failing to make the grade, there is a large cost and time-pressure for pharmaceutical companies.

Many of these companies are using legacy IT systems which lack the ability to integrate with newer systems. This can cause information silos, where mandatory information is isolated from the systems that it needs to be on. With clinicians, doctors, and research scientists using modern applications to collaborate, automated workflows can ensure that all the dots are connected.

When an employee is looking to compile reports for the FDA, they need to be able to access the documents and information required at a moments notice. This need for visibility and transparency across organizational documents must be extended to relevant authorities.

This way, approval can be sped up, drugs can be brought to market quicker, costs can be reduced—and, ultimately, lives can be improved.

Automate with Nintex

With Nintex, you can manage, automate, and optimize processes that govern best document management practices. This will enable pharmaceutical companies to solve the challenges of regulatory compliance, as well as improve efficiency, accuracy, and speed to market for their products.

The benefits for pharmaceutical organizations are as follows:

  • Eliminate silos
  • Provide greater transparency
  • Allow easy access to all stakeholders
  • Establish reliable audit trail for documents and records
  • Key data is always captured
  • Generate reports and insights


To learn more about how Nintex can help your company (whatever your industry) overcome the challenges of regulatory compliance, get in touch with our team today.


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