Activating software is a technical achievement, but transforming this asset into operational behavior, with proven compliance and repeatable value, is delivery work. In highly regulated markets (such as healthcare, pharmaceuticals, food, and energy), the ability to take software deployment to that next level is what defines whether investment strengthens the business or simply creates more operational risk.
In this sense, the evidence is clear: when digital transformation initiatives have a low success rate, it is not due to technology limitations, but due to a failure to incorporate it into routine, governance, and business metrics. According to research by Oxford Economics, only 41% of companies strongly agree that transformation initiatives generally have clear objectives in their companies.
Therefore, executives and leaders need to adopt a methodological approach to ensure that the implementation of a solution generates compliance, risk reduction, and creates tangible, ongoing value for their companies.
The cost of not having a strategic delivery
Transformations fail often, and the cost of that is real. Longitudinal studies show that most transformation programs do not achieve the expected objectives: in ERP/management environments, Gartner projects that, by 2027, more than 70% of recent implementations will not fully meet the original business case. In other words, this is not a mere technical detail; It is a financial and operational risk.
In addition, the cost of incidents and non-compliance can be high. IBM’s report on the costs of data leaks shows that the impact of these occurrences reached almost 5 million dollars in 2024. At the same time, specialized studies show that the aggregate costs of non-compliance often outweigh the investment required to maintain robust compliance and control programs.
In short: failing to adopt is not just an IT problem; It is a risk that affects revenue, governance, reputation, and shareholder results.
Conformity needs to be lived, not just written
Documents and manuals can generate regulatory comfort. However, actual compliance is measured by operational evidence, i.e., tasks performed in the tool, automated audit trails, reproducible indicators in internal audit, among others.
Without these elements, the company will have the documentation, but it will not put everything that is in it into practice. More than that, she won’t even have the control of knowing if things are working out — and what should be done if they aren’t.
Therefore, you must start tracking some KPIs that demonstrate lived compliance. These indicators, of course, vary according to the sector and the product/service of each company, but some of the most commonly used are:
- The execution rate of critical processes within the platform;
- The percentage of automatically generated electronic evidence;
- The average time to remediate non-conformities;
- The trend of findings in internal audits (both pre and post-implementation of the tool).
In addition to simply having these indicators, they must also be part of the organization’s governance dashboards. In other words, it is not enough to obtain this data; it is vital to monitor and analyze it frequently, with reviews on a cadence of 30, 60, and 90 days, and then quarterly.
In this way, your company can transform all the compliance care that exists in planning into something tangible for all teams. Even more important than that, it facilitates the monitoring not only of how the software was implemented, but also if its use complies with the main norms and standards relevant to the sector in which it operates.
What you need to do to provide consultative delivery
The important thing to provide truly consultative delivery, which goes beyond simple software implementation, is to know that treating this only as a technical project is insufficient. In addition, the delivery must be consultative and incorporate elements such as specialized methodology, phased application, focus on compliance, integration with other tools, among other characteristics.
Below, I list seven of the main activities, strategies, and precautions that can help your company implement a truly consultative delivery that brings value to your customers far beyond the moment of implementing the solution.
1. Consolidated methodology and expert teams by industry
First, have product specialists who master not only your products and your business model, but also the most relevant regulatory requirements for your sector (such as GxP, Anvisa, NBRs, FDA, among others). This makes a big difference between a generic implementation and one that focuses on ensuring regulatory compliance.
2. Phased planning (it can take from one month to one year).
The first step to a successful and value-generating implementation is to focus on planning it. Implementation is the first step, and should include all steps, tasks, and processes from pilot to full rollout – and its duration should reflect the criticality and scope of the project.
In this way, you can anticipate a series of factors, such as costs, personnel demand, areas that will be involved, expectations of results, and metrics that need to be monitored, among others. This way, it is possible to aggregate the quick wins calls at each step of the process.
3. Evidence and audit-driven configuration
Once you’ve gathered your qualified team and planned the delivery process, it’s time to start implementing your software. To reinforce compliance, remember that the product must be delivered with trails, playbooks, and validations that prove compliance in audits, both internal and external.
4. Integrated change management
Performing poor organizational change management is a critical mistake that can undermine the entire delivery of the solution. To prevent this from occurring, ensure that every detail of the implementation is understood by everyone. Stakeholders must understand that the goal is to bring more efficiency, agility, and compliance. In addition, they must be able to track data such as deadlines, scope, and budget, among others, with practicality.
5. Onboarding and post-live services
Onboarding is just the beginning. It is necessary to provide continuous support and dedicated teams that sustain the results in the long term. For this, you can either rely on analysts in your own company or even opt for outsourcing services — it all depends on what your company’s structure is like.
6. Secure integration with the ecosystem
To deliver value that goes beyond the implementation of software or the onboarding of the solution, it is important to ensure that your tool has integrations that preserve security, traceability, and data analysis. In other words, there is no point in providing the most complete application in the world if it does not connect securely (and with regulatory compliance) to other applications already in use by your customer. Among the most common are ERP, PLM, and RM.
7. Artificial Intelligence as an operational tool
The trend of using AI has been gaining strength, and soon it will no longer be a trend, but a standard tool adopted by almost all companies. In the case of delivery, Artificial Intelligence can automate tasks such as contractual analysis and evidence extraction, accelerating compliance with quality and consistency. This generates customer confidence in your service, which is the main asset they are looking for when hiring technological services.
The most common mistakes in software implementation and how to avoid them
Even in large-scale companies or those operating in highly regulated industries, it is common to observe failure patterns that occur in various implementation projects. These mistakes imply rework, conflicts and loss of sponsorship; And these effects impact time, cost, and compliance.
Among the main obstacles that you should avoid are:
- Exclusive focus on time/budget, neglecting organizational change. To fix this, you need to integrate change management into your schedule and budget.
- Not mapping the impact of implementation or involving the executive committee. The way to avoid this problem is to provide a project governance dashboard, with checkpoints with executives and a map of the project’s main stakeholders.
- Conduct punctual and generic training. Instead, create personalized training tracks for each employee’s profile (operator, manager, auditor, etc.) and make these qualifications available virtually and continuously.
- Poorly designed integrations. From the first minute of the project, ensure that the integration architecture is well defined and with the mapping of the main integrations. Also, include controls, logs, and audit tests in these integrations.
What leaders should demand in the post-live of software implementation
To ensure that the solution delivers value long after its installation, it is necessary to have some elements: close and continuous monitoring of results, goals that bring a reliable overview of the use of the tool, and an organizational culture that seeks to get the most out of the application.
The easiest and most efficient way to offer this is to provide a dashboard with clear goals, understandable KPIs, and those responsible for each initiative/metric. Some of the information you should keep track of is:
- Follow-up adoption by the critical process. For example, track the goal of implementation and overall utilization of the tool. A widely used rate in the market is to have approximately 80% effectiveness within 90 days — but remember that this goal must be adapted to the context of each company.
- Reduction of non-conformities. Get comparative data on the volume of non-conformances before versus after implementation. This helps to make the tool’s positive impact on regulatory compliance tangible.
- Reduction of the average execution time of critical tasks. The gains can go beyond compliance. Also, track which tasks gained in agility, efficiency, and security after implementing the solution to understand its overall impact on your operation.
- Incident resolution SLA. Include in the dashboard the average resolution time of any incidents and non-conformities to find out how the tool helps to speed up these actions. Have both the information regarding the SLA time of resolutions, as well as the percentage of their completion (and the percentage of any reductions in this type of occurrence).
Visualizing indicators like these helps translate technology into performance and regulatory protection. Good practice is to make them accessible (as long as it is secure) to all project stakeholders to expand the understanding of the value of the tool once it is implemented.
How we accelerate service delivery at SoftExpert
At SoftExpert, we believe that technology, combined with methodology and service, reduces uncertainty and accelerates value delivery. Thus, it is possible to act more economically than with entirely customized and reactive paths.
In practice, this means that we combine three pillars to accelerate results and reduce variability:
- Pre-configured solutions in the Store. We provide some ready-made process/action templates for our customers to access in our Store. In this way, companies reduce implementation time and implement good industry practices with agility and compliance without great effort.
- Delivery services with expert teams in the industry. All our deliverables are compliance-driven, with phased plans and close project management. To this end, we have teams of experts in various sectors and industries, who understand the regulatory specificities of each of these markets.
- Seamless services and integration with AI. Our Delivery area provides operational support and offers Artificial Intelligence agents that automate reviews and evidence extraction. In addition, we offer outsourcing with our dedicated analysts.
Trends that will mark the future of software implementation
As in all areas involving technology, the future holds many changes for the delivery of solutions. Among new tools and different operating models, the sector must have even more focus on agility, compliance, and process automation with AI.
My interpretation of the market indicates that the main trends that should guide companies (whether those that offer software solutions or those that consume them) are the following:
- Increasingly faster and modular implementations: Pre-configured and practical product-led delivery solutions should gain more space. The market is looking for quick solutions to be implemented (such as our Store, for example), and this type of strategy meets this demand.
- Operationally embedded AI: Offering Artificial Intelligence agents that operationalize contracts, extract evidence, and guide regulatory checks will be a differentiator against the competition. AI accelerates implementation and, later, the use of software; therefore, it will be very present in several segments.
- Hybrid support models: It will be essential to combine automation via AI with the presence of dedicated and specialized analysts to ensure continuous governance within the application. This way, you can maximize the forms of support and ensure that customers will have service (whether automated or with a human attendant).
In addition to all these technologies and tools, the main trend will be the increasing importance of conscious, measured, and governed adoption of solutions. This allows you to maximize benefits without losing sight of regulatory compliance.
Read also: How strategic alliances expand the perception of value in complex markets
Conclusion
Activating a system is just the beginning. If compliance does not materialize in the routine, the organization will have consumed capital without protecting value, and this is unacceptable in regulated markets. The way to prevent this from happening is up to leaders and executives. Risk leaders and CIO/CTO, for example, must demand metrics, governance policies, and a delivery that translates strategy into operation.
My final recommendation is to prioritize the following strategies:
- Have consolidated and customized methodologies by industry;
- Carry out a realistic and phased planning of the implementation of the software;
- Create deliverables that can also prove evidence of compliance in audits;
- Provide continuous and personalized support to its customers;
- Have a roadmap for using AI to increase efficiency and maintain compliance.
Without these elements, the software will be installed, but delivering value and strengthening compliance will remain just a document or a distant goal to be achieved, but one that is not really prioritized.
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!
