In industries such as healthcare, finance, and energy, technology is vital to staying competitive. Still, these companies face unique challenges to put digital transformation into practice in Brazil.
McKinsey studies indicate that leading companies in digital maturity in the country record growth in Earnings Before Interest, Taxes, and Amortization (EBITA) up to 3 times higher than their competitors. However, at the same time, the spread of this maturity is still moderate: the average Digital Transformation Index Brazil (ITDBr) of companies went from only 3.3 in 2023 to 3.7 in 2024 (on a scale of 1 to 6).
In the case of intensely regulated sectors, such as Health, there was an increase from 3.0 to 3.5. This shows that there is room for digitalization to be a great ally in the pursuit of governance and compliance. However, this movement is still embryonic.
About 31% of Brazilian industries have not yet adopted digital technology. These data indicate that, although there have been advances, companies in regulated environments still need solid strategies to combine innovation and compliance. It is necessary to go beyond the technological barrier and know how to unite tools, compliance, and a culture of innovation and compliance.
Only then will companies be able to go beyond superficial transformation and be able to add technologies and solutions that take their operations to the next level. And for this, it is essential to understand what the pitfalls are that your company should avoid.
The Challenges of Compliance in Digital Transformation in Industries
Integrating innovation and compliance is a major challenge. Regulatory matters are difficult to deal with in highly regulated markets. Rigorous audit follow-ups, for example, can hinder efficiency and the adoption of new technologies.
Simultaneously, this requires companies to always have their processes up to date. In other words, strict standards (such as sanitary, data, financial laws, etc.) and frequent inspections can reduce operational agility, requiring constant investments in governance so that bottlenecks do not arise.
Leaving this aside is one of the great dangers for digital transformation in this type of market — and yet it is something very frequent in Brazil. According to a survey by the Dom Cabral Foundation in partnership with PwC, Brazilian companies give increasing relevance to innovation, but this maturity will remain at low levels as long as there is no adequate governance strategy.
An example of this is the still frequent lack of alignment between technical, legal, and operational areas in Brazilian industry (which is even more dangerous in regulated sectors). Many companies struggle to incorporate digital transformation into their existing projects: 51 percent of executives cite problems integrating digital initiatives, and 50 percent say they struggle to structure them into a seamless process, according to the Digital Transformation Index.
In addition, compliance costs and risks of non-compliance increase change aversion. In the 2024 Digital Readiness Index, Brazil ranked 84th in “regulatory quality” out of 133 countries, highlighting the legal and bureaucratic obstacles that exist in the country. When looking at this data, managers must carefully plan the changes that will be made and, more than that, anticipate legal requirements when adopting new technologies.
Technology must go hand in hand with regulatory innovation and compliance
To face these challenges, specialized platforms play a key role. In the case of SoftExpert, for example, our strategy combines document management, processes, risks, quality, change control, and system validation in a single solution.
In this way, we enable companies to achieve compliance with key global standards across a variety of industries without sacrificing the desire to innovate and automate. This was the case of Frilabo, a Portuguese company with more than 25 years of experience, specialized in laboratory solutions and metrology services.
Thanks to SoftExpert Suite, the company can automate critical processes, such as change control, non-conformance management, equipment calibration, and staff training, and thus achieve more transparency and agility in decision-making.
But it’s not enough to make tasks easier and drive regulatory compliance. True digital transformation brings to the now those trends that seem to belong to tomorrow. For example, our solution allows us to apply Artificial Intelligence (AI) to understand how products/services are performing and thus allow companies to act on it.
In practice, this means digitizing 100% of document management (SOPs, ITs, quality manuals, etc.), facilitating audits and ensuring automated audit trails, for example.
It is digital initiatives like these that can reduce the time spent on inspections and audits by up to 50%, while process automation increases productivity by about 40%. Such operational gains are essential for leaders and managers to justify investment in technology.
Therefore, by adopting digital compliance platforms, companies in heavily regulated sectors have greater traceability and security in quality management processes, thus increasing legal compliance in their operation.
Combining digital solutions with business strategies
The success of the digital journey depends on using key technologies strategically and aligned with a company’s business benefits. The pillars of this framework will mainly be AI, Big Data, and other data collection and analysis tools. These technologies allow you to transform the large volume of information into risk, quality, and performance insights with ease and agility.
In Brazil, 67% of companies already consider artificial intelligence among the top five strategic priorities for 2025, according to a survey by Bain & Company. The use of generative AI dominates this growth: the same study shows that a quarter of Brazilian companies have at least one use case based on this tool.
The Internet of Things (IoT) is also gaining momentum: the use of sensors and connected devices allows you to track critical assets in real time, which is essential in regulated environments. IoT devices feed big data analytics, making it possible, for example, to perform predictive maintenance on medical equipment or remotely control production parameters in a pharmaceutical line.
In addition, secure cloud computing platforms and the use of models in data lakes are part of the tools that place technology at the center of digital transformation in regulated markets and that serve the market vision and business strategies of companies. Thanks to this union between tech and business, leaders adopt agile implementation methodologies, clear goals, and dedicated governance, such as multidisciplinary innovation and compliance committees.
The culture of innovation is key to digital transformation in Brazil
In addition to relying on technology and business acumen, digital transformation also depends on organizational culture. It is what drives this movement forward – and it is the lack of it that can put all this at risk: “organizational culture” is pointed out as the biggest obstacle to digital transformation in Brazil, according to the Brazilian Digital Transformation Index 2024.
People management is one of the greatest precautions in this regard. It is necessary to start with the ability to deal with technology and take advantage of it. In practice, this involves engaging teams by showing the concrete benefits it offers and simplifying the adoption of applications and tools. I recommend the “less is more” principle: starting with low-risk, high-impact pilot projects, thus ensuring quick wins and valuable learnings.
Gamification https://www.softexpert.com/pt-BR/modulos/gamification/ and other incentives can increase employee adherence, demonstrating that innovation brings advantages (such as reducing repetitive manual tasks, for example). In addition, leaders must clearly communicate the purpose of the change, connecting the new processes to the company’s compliance and quality goals.
Technology itself can be used to monitor this engagement: for example, using AI to analyze logs of natural use of systems, identifying adoption patterns, and the need for additional training.
And most importantly, don’t forget that cultivating a resilient digital culture requires patience, training, and openness to feedback, keeping teams informed and participative at every step. Without people, there is no truly useful technology.
Studies showhttps://www.deloitte.com/br/pt/services/consulting/perspectives/medindo-valor-transformacao-digital.html that 70% of global organizations recognize digital transformation as a critical investment; however, 75% report difficulty in measuring success. In other words, technology alone will not bring success; It is essential to have metrics aligned with business objectives to get the most out of these tools.
The opportunities that await those who excel in digital transformation in regulated industries
When well applied, digital transformation brings operational excellence, competitive advantage, and direct impacts on business results. Companies that manage to unite innovation and compliance achieve standardized processes, digital security, and compliance with the main standards and agencies of various sectors, strengthening their corporate governance, reducing legal risks, and protecting their reputation in the market. This alignment also generates greater appreciation of the company among investors, who recognize the solidity of controls and the ability to respond to regulatory requirements.
In practice, this means achieving greater efficiency (fewer operational errors), mitigating risks of non-compliance (with accessible history and documentation), and raising the level of internal control, which is essential to avoid penalties and reduce provisions for contingencies. In addition, the agility in responding to audits and the clarity in reporting reinforce the confidence of shareholders and the board of directors in conducting business.
Studies corroborate these gains: companies that implement generative AI, for example, have reported average increases of 14% in productivity and 9% in financial results. Additionally, with integrated processes, organizations can respond more quickly to regulatory changes, reducing fines, disruptions, and potential brand damage.
Even in traditional sectors, there is also potential for innovation in services that reinforce credibility in the market. For example, in the Healthcare market, the integration of data with AI makes it possible to monitor the quality of care and predict clinical risks, creating therapeutic value, greater safety for patients, which translates into improved reputation and internal efficiency gains.
In the pharmaceutical industry, digital R&D solutions accelerate compliance with requirements such as GMP system validations, optimizing the drug development cycle. In the case of the pharmaceutical company Apsen, by using the SoftExpert Suite, the company can manage more than 767 procedures and 1,300 forms managed on the platform, in addition to more than 20 thousand online training sessions in four years.
The most common mistakes and what to learn from them
In digital transformation initiatives in regulated industries, there are recurring pitfalls. Many companies forget that the best is the enemy of the good when pursuing initial perfection. Thus, they end up not validating solutions incrementally, lack continuous improvement, and fail to create innovation routines that involve employees.
This translates into implementing changes very quickly (even when there is no real urgency to do so) and, therefore, skipping basic testing and alignment steps. The results in these cases could not be worse: solutions are rejected by end users and projects fail.
Another common failure is not listening to stakeholders. Ignoring the needs of those who will use the technology, whether operators, auditors, or suppliers, for example, leads to rework and low adoption.
To avoid these mistakes, try to involve teams from the planning (co-creation) of projects and establish short delivery cycles (such as in the format of sprints) with continuous validation. Also, align each transformation project with regulatory requirements already in its conception. This way, you can reduce internal resistance and ensure that innovation does not compromise the legal requirements of your market.
What to expect for the future of digital transformation in Brazil
If you are still getting used to all the changes and paradigm shifts that technology has been presenting in recent years, get ready: the near future holds even more disruptive advances.
Artificial intelligence will continue to be in evidence; it is estimated that by 2028, more than a third of enterprise applications will incorporate AI agents capable of automating about 15% of daily decisions. These “intelligent agents” promise to speed up compliance tasks, such as screening documents for auditing or real-time risk analysis. In addition, the expansion of IoT will continue, with sophisticated and connected sensors that will allow greater control of regulated processes (such as the tracking of drugs from manufacturing to the patient, for example).
Greater use of advanced analytics is also expected. Financial and operational big data will be integrated with predictive models, supporting strategic and rapid decisions. In terms of regulation, companies must prepare for AI-related adaptations, either by meeting future data ethics standards or by qualifying AI systems in a way that can be validated with agencies – for example, following the guidelines of ISO 42001.
In this new scenario that is approaching, leaders in regulated markets must drive digital transformation by combining prudence and audacity. Trends point to an environment where data and AI connect efficiency to compliance, where IoT and intelligent agents amplify the capacity for innovation.
Following good practices, such as having solid governance, a collaborative culture, and clear goals, will allow you to take advantage of opportunities and comply with strict regulations safely. Leading this digital journey in a structured way will ensure that your company not only survives, but thrives, creating sustainable competitive differentiators in sectors under heavy regulation.
Conclusion
In an increasingly digital and regulated world, taking a structured and coordinated approach to digital transformation is not just an option, but a strategic necessity. Balancing innovation and compliance ensures that technology initiatives move forward without ignoring legal and regulatory obligations. In contrast, the intelligent use of technologies such as AI and big data drives operational efficiency and informs data-driven decisions.
In addition, strengthening a resilient digital culture, in which teams are engaged and prepared for constant change, is essential to sustain results in the long term.
Decisions must always be conscious and based on solid governance, with a focus on sustainable results and competitive differentiation. The future of digital transformation in Brazil involves strengthening governance processes, training professionals in digital skills aligned with regulatory requirements, and adopting metrics that connect innovation to compliance.
Only in this way will we convert regulatory challenges into competitive advantages, building agile, safe, and lasting operations, aligned with the vision of excellence of leadership that the market and its stakeholders expect.
Looking for more efficiency and compliance in your operations? Our experts can help identify the best strategies for your company with SoftExpert solutions. Contact us today!
