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RPA and Regulatory Compliance in Pharma: 5 Things I Wish I Knew Sooner

5 min read
Sep 21, 2020 10:00:00 AM

Being part of a highly regulated industry, pharmaceutical companies face the incredibly challenging task of complying with many rules and regulations across all aspects of their business. In recent years, the number and complexity of regulatory business requirements have increased substantially, and there does not seem to be a change in sight.

Pharmaceutical companies are particularly challenged with responding to this ever-changing regulatory environment because, for them, non-compliance has a profound effect on cost, reputation, and, ultimately, the lives of their customers or patients. For that reason, more and more pharmaceutical organizations are looking at how RPA in Pharma can automate and improve their regulatory compliance activities.

The complex and unprecedented challenge of maintaining corporate compliance in a digital world has increased external pressure on these organizations to heighten transparency and adopt innovative technologies like RPA. This, combined with the ever-evolving needs of existing and emerging customers, drives pharmaceutical companies to re-examine their approach for better compliance solutions.

The most significant dilemma that pharmaceutical organizations face is the tricky balancing act of driving business innovation and achieving goals while simultaneously mitigating compliance risk.

We have found that most of the world's largest pharmaceuticals face the same five challenges.

By recognizing these five key challenges sooner and developing compliance strategies that address them head-on, pharmaceutical organizations will see how their compliance solutions can be transformed from a risk/cost into a value-driven, competitive advantage.

1. An enterprise-wide view of compliance risk is absolutely critical

From our experience, we have found that most large pharmaceutical organizations address regulatory compliance changes the same way: within silos of individual business or operational teams. The problem with this approach is that not only is it highly inefficient, it significantly complicates the definition of compliance responsibility.

Clearly, managing compliance responsibilities this way is inefficient, so why do all companies do it the same way?

We have asked ourselves this question, and after working with the world's leading pharmaceutical organizations, we think we have uncovered the missing piece. There is a need for an enterprise-wide view of compliance risk, but how do we get that if everyone works independently?

Compliance committees!

These committees help align responsibilities and introduce a consistent company view of corporate compliance. A single 'owner' of compliance risk will not only ensure everyone has the same working definition of compliance solutions but will also make everyone accountable to a committee that oversees compliance in the organization and industry. It's key that these committees are also closely aligned with RPA CoEs (Centers of Excellence) in Pharma. This ensures that compliance activities can also be prioritized as RPA candidates and that the bots being developed are thoroughly scrutinized and risk-free.

2. You can't overlook the role of Big Data

Data is powerful, but big data is even more powerful. Yes, it comes with its challenges, but when big data is analyzed well, you can guarantee great insight for your organization.

For large pharmaceutical companies using big data analytics effectively is challenging for two reasons:

  • Legacy technology and IT infrastructures are challenging to integrate, so accessing and analyzing data proves to be extremely problematic.
  • Most compliance leaders depend on manual reporting systems, which depend on complex, resource-intensive, and time-consuming processes prone to error.

Big data is effective when the organization clearly defines an IT infrastructure strategy that focuses on the system's need to reach compliance early on. We have found that the system delivers an enterprise-wide view of compliance risk, which reduces potential risks. To do this successfully, we suggest identifying 'Key Risk Indicators' to quantify new or emerging risks.

Leveraging big data with process or task mining tools that comb through event logs can also uncover hidden compliance processes that can be automated, presenting key value-add use cases to RPA in Pharma.

3. The faster you switch to an ethic/integrity-driven approach, the better

Within the pharmaceutical industry, we have noticed that the typical compliance program takes on a simple rule-based approach that discourages collaboration and agility. This is extremely ineffective and can lead to non-compliance.

That being said, organizations that want to implement a change model to improve their compliance practices should quickly adjust their approach from rules to a code of conduct focused on ethics and integrity.

We have found that a code of conduct that focuses on ethics and integrity in regulatory compliance works best because it is something to which all levels of the organizations must adhere. Switching to an ethics/integrity-driven approach encourages a cultural shift and greatly reduces the risk of non-compliance. This approach enables collaboration and makes it easier for cross-functional teams to work together. An ethics/integrity-driven approach balances the needs of the business with the needs of the regulators.

4. The compliance training and skill set is changing, companies with the most mature compliance functions will win the talent war

As the regulatory compliance landscape changes, the necessary employee skillset does too. Companies need to hire the right people with the right skill set to stay compliant. Companies with the best reputation and the most mature compliance functions are going to win the talent war.

How can your organization come out on top?

Don't jump the gun and start looking for talent outside your company; nurture the people you already have and mold them into the compliance specialists you need them to be. We have seen some of the most successful organizations develop in-house compliance training programs available to all employees. Not only does this sustain your current talent, but it also boosts employee morale and company reputation.

In regards to RPA in Pharma, one of the defined roles of a strong RPA CoE is to act as automation evangelists within the organization, sharing best practices and the knowledge they have accumulated. Regular knowledge-sharing and dialogue between your RPA CoE and compliance teams is another way to ensure your talent is receiving the skills to set the organization and its employees up for success in the future.

5. A centralized resource/requirements management repository is imperative

Implementing a centralized repository managed by local and global compliance officers is bound to revolutionize how your organizations access regulatory information.

A common problem that we have seen is that global compliance organizations struggle with keeping an up-to-date regulatory repository, which can be detrimental to smaller and local branches. Regulators are putting disproportionate demands on pharmaceutical companies, and smaller branches are struggling to keep up.

With emerging technology that leverages artificial intelligence, compliance teams can now keep a diligent pulse on new and evolving regulations. Blueprint, for example, can ingest regulatory controls as they're published and automatically push them to relevant owners, making analyses and interpretations much more effective and efficient. From Blueprint's central repository that houses all regulatory constraints, these dependencies can then be connected to all impacted processes to facilitate change management and risk analysis not just for RPA in Pharma, but for pharmaceutical compliance teams in general.

To see how Blueprint can elevate your compliance teams and how you use RPA in Pharma, get in touch with one of our experts here.