How do you define regulatory watch?

Firstly, regulatory watch is an activity that consists in identifying, on a day-to-day basis, the legal texts applicable to an organization.
Secondly, it involves monitoring the evolution of these texts: new, amended or repealed texts.

Legislative production can be national, European or international. And the regulatory fields covered may be in the HSE field: Environment, Health & Safety, Energy, Food Safety, Transport, etc., but also other rights such as HR, Finance, Data Protection, Commercial, etc.

What do companies need in terms of regulatory intelligence?

Coping with regulatory pressure or anticipating change are often the challenges of setting up a structured regulatory watch.

The aim is to be informed in real time of regulatory changes specific to the company’s activity (and also in the event of a change in activity):

• new applicable text,
• modification of an existing text,
• repeal of a text,
• draft new text

CONFORMITY OR CONFORMITY ASSESSMENT

Mise en place d’une veille réglementaire automatique et centralisée puis évaluation de la conformité :

After monitoring, we define the process to be put in place to comply with these applicable legal requirements. This is called compliance.

The aim is to assess the conformity of installations, processes, infrastructures, etc. for each applicable requirement, and to rule on compliance.

The regulatory compliance audit is a tool for assessing a site’s compliance with the regulatory requirements applicable to it, as determined during the prior regulatory watch process.

The aim of a regulatory compliance audit is therefore to assess compliance or possible non-compliance with a requirement, and to propose corrective and improvement actions for the site concerned.

This assessment enables the company to better manage and steer all its activities in line with applicable regulatory requirements, and to be fully aware of its level of compliance with regulations, standards and Group requirements.

Companies’ compliance needs

Examine the Site’s compliance with applicable regulatory requirements.
In the event of non-compliance, Sites must be able to demonstrate that they have credible Action Plans in place to deal with inspections by the authorities or in the event of an accident.

What’s the practical application?

Regulatory monitoring and compliance are sometimes used as the basis for an HSE strategy, or for ISO 45001 and ISO 14001 audits. These two processes are essential to a sound HSE strategy, especially for industrial companies.

Use cases of our NV Compliance tool for regulatory monitoring and compliance

Biopharma use cases

Use cases in

To find out more about regulatory watch?

Comment réussir sa veille réglementaire en 5 étapes?

Comment bien choisir son outil de veille réglementaire

1. What is ISO 9001: definition

ISO 9001 is an international quality management standard designed to ensure that products and services meet the requirements of customers and stakeholders, while adhering to management principles such as customer focus, leadership, people engagement, process management and continuous improvement. It establishes a framework for optimising organisation, ensuring compliance, enhancing customer satisfaction and promoting operational excellence.

The next revision of ISO 9001-2026, expected to be published in 2026 (probably in October), is progressing towards the final draft stage and is expected to have the same structure while offering modernisations.

Why these changes?

The previous version of ISO 9001 dates back to 2015.
Since 2015, many societal and social changes have taken place. For example:
In the digital sphere: data has become a major issue, as have cyber security and artificial intelligence.
New customer expectations: huge growth in e-commerce, increasing importance of social media and the customer experience designed as an omnichannel experience.
Climate and sustainability: these current issues and their consequences must also be integrated into corporate strategy and therefore into the ISO9001 standard.
Resilience to crises: implementing health and geopolitical risks and supply chain disruption issues.

2. Main changes expected for ISO 9001:2026

The changes in version 2026 are gradual but strategic, focusing on seven key areas:

1. Integration of climate change.

   As in ISO 14001 and ISO 45001, climate risks and opportunities must now be integrated into the organisation’s strategy (clause 4.1). This revision is based on the 2024 amendments, which require organisations to take climate-related risks and opportunities into account in their strategic vision, thereby strengthening environmental responsibility within management systems in general.

2. Strengthened leadership and quality culture.

   Article 5.1.1 specifies that managers must embody and promote ethics and a culture of quality at all levels. Leadership is no longer just responsible, but exemplary: it sets the tone and embodies the expected behaviours. A few examples are provided to managers to demonstrate their commitment.

3. Quality policy and strategic alignment.

   Quality policy and strategic alignment.

4. Optimised risk and opportunity management

   The reorganisation of clause 6.1 makes it easier to distinguish between risks and anticipate major opportunities for resilience. From 2026 onwards, the standard should explicitly separate the analysis of risks and opportunities in order to help organisations structure their approach, reporting and management in these two areas.

5. Employee awareness and engagement

   Awareness requirements have been expanded; quality culture and ethics must be known, understood and practised in the field. According to clause 7.3, employees must adopt behaviours that promote quality and integrity at work.

6. Technology: digitalisation, data and digital tool management.

   The standard recognises the importance of cybersecurity, software reliability and data management in measuring and controlling quality. These new requirements involve validating the digital tools used for quality management in order to guarantee the reliability and cybersecurity of processes.

7. Sustainability and stakeholders

   The expansion of the ESG (environmental, social, governance) scope now requires the inclusion of specific environmental and social performance indicators in the quality strategy, facilitating cross-functional reporting with ISO 14001 and 45001 standards.

8. Harmonisation and improved guidelines

   The addition of practical examples and improved compatibility with ISO 14001 (environment) and ISO 45001 (safety) standards simplify system integration.

3. What steps should be taken to prepare for this?

• Conduct a gap analysis in relation to the new requirements.
• Update the quality documentation and review the documentation scheme.
• Train teams, particularly senior management and managers, in quality culture, ethics and resilience.
• Adapt supply chain and supplier management to anticipate disruptions.
• Strengthen the validation of digital tools (software, AI) used to manage quality.
• Integrate customer satisfaction and feedback loops into QMS management.

4. What are the risks and opportunities associated with this update to the ISO 9001 standard?

Opportunity for improvement of the ISO 9001 standard :

• The standard proposes a sustainable, modern quality system that is connected to current issues.
• Concern for strategic alignment with the expectations of customers and stakeholders.
• More visible leadership, a culture of quality and ethics valued.
• Increased resilience to supply chain risks.
• Facilitated synergy with ISO 14001/45001 for multi-system organisations.

Risks or negative points:

• Transition costs (process updates, training, gap analysis).
• Transition costs (process updates, training, gap analysis).
• Concepts that are sometimes abstract or difficult to implement in practice (quality culture, climate context).

In conclusion: why and how should you prepare for the changes to the ISO 9001 standard and maintain your certification? Here are a few tips 👇

The new ISO 9001:2026 version is not a complete overhaul of ISO 9001:2015. It builds on the latter and develops it further by incorporating current issues such as technological change and climate and societal challenges.

The revision aims to update the standard so that it remains relevant to technological changes, new customer expectations, and climate and societal issues. After official publication in September 2026, organisations will have three years to migrate to the requirements of the new standard, with the 2015 version remaining valid until 2029.

Key steps to prepare effectively:

• Update the analysis of the context, particularly climate and ESG.
• Review how management promotes a culture of quality.
• Modernise the management of data, tools and technological biases.
• Boost customer and stakeholder engagement, strengthen risk planning and resilience.
• Follow the resources, guides, and transition training offered by certification bodies.

In conclusion: ISO 9001:2026 modernises quality by strengthening customer culture, ethics, resilience and digitalisation. The key is proactivity – engaging management, raising staff awareness and consolidating the value of the QMS in the service of customer satisfaction and continuous improvement.

Novallia supports you in understanding the new challenges posed by the standard and, thanks to its network of partners, will accompany you through the transition to 2026. Contact us!

The Annual General Meeting of Novallia (Holding), the Group’s parent company, took place on May 23, 2025 in Neuchâtel (CH), under the chairmanship of Patrice Gabus, President & CEO.

After two financial years, 2022 and 2023, marked by stable sales figures but significant losses due to the computer attack in June 2022, financial year 2024 saw sales growth of 67.5% and an EBITDA (operating profit) margin of over 30%. Net income after tax, Group share, exceeded 10%.

Patrice Gabus, the Group’s majority shareholder, expressed his thanks:

• To our teams, who have shown extraordinary resilience and energy over the past three years. In just 4 months, they managed to reinvent an Application, rebuild databases and complete documentation that had been destroyed during the blackout.
• To our customers, 98% of whom have remained loyal to Novallia
• To the shareholders and its investment fund Sopromec, who remained patient and constructive.

The General Meeting also elected 2 new directors, Laura Perret and Raphael Leveau, and appointed Fiduciaire Muller Christe & Associés as Auditors, in the person of Sébastien Charpié.

Fiscal 2025 once again looks promising, with sales growth of 32.5% in Q1 2025. The Board of Directors expects sales growth of 25% and an EBITDA margin of at least 20%.

👉 𝐄𝐱𝐭𝐞𝐧𝐬𝐢𝐨𝐧 𝐝𝐞 𝐥𝐚 𝐩𝐞𝐧𝐬𝐢𝐨𝐧 𝐝𝐞 𝐫𝐞𝐭𝐫𝐚𝐢𝐭𝐞 to émigrés, reinforcing social security for Senegalese in the diaspora.
👉 𝐅𝐮𝐬𝐢𝐨𝐧 𝐝𝐞 𝐥’𝐈𝐏𝐑𝐄𝐒 𝐞𝐭 𝐝𝐞 𝐥𝐚 𝐂𝐚𝐢𝐬𝐬𝐞 𝐝𝐞 𝐒𝐞́𝐜𝐮𝐫𝐢𝐭𝐞́ 𝐒𝐨𝐜𝐢𝐚𝐥𝐞, for simplified and optimized management of social security contributions.
👉 𝐑𝐞𝐧𝐟𝐨𝐫𝐜𝐞𝐦𝐞𝐧𝐭 𝐝𝐞 𝐥’𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 𝐝𝐮 𝐓𝐫𝐚𝐯𝐚𝐢𝐥 with additional resources to better frame and enforce regulations in the workplace.
👉 𝐍𝐨𝐮𝐯𝐞𝐚𝐮 𝐏𝐚𝐜𝐭𝐞 𝐝𝐞 𝐬𝐭𝐚𝐛𝐢𝐥𝐢𝐭𝐞́ 𝐬𝐨𝐜𝐢𝐚𝐥𝐞 to encourage enhanced dialogue between unions, employers and government.

These reforms mark a strategic step for companies:
📌 𝐀𝐝𝐚𝐩𝐭𝐚𝐭𝐢𝐨𝐧 𝐫𝐞́𝐠𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐢𝐫𝐞 : An imperative to remain compliant in the face of legal developments.
📌 𝐆𝐞𝐬𝐭𝐢𝐨𝐧 𝐩𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐝𝐞𝐬 𝐫𝐞𝐬𝐬𝐨𝐮𝐫𝐜𝐞𝐬 𝐡𝐮𝐦𝐚𝐢𝐧𝐞 : An opportunity to strengthen the attractiveness and retention of talent.
📌 𝐃𝐢𝐚𝐥𝐨𝐠𝐮𝐞 𝐬𝐨𝐜𝐢𝐚𝐥 𝐞𝐭 𝐫𝐞𝐬𝐩𝐞𝐜𝐭 𝐝𝐞𝐬 𝐧𝐨𝐫𝐦𝐞𝐬 : New perspectives for structuring and improving relations with social partners and regulatory authorities.

At hashtag Novallia, we can help you through this transitional phase. With our expertise in regulatory watch and compliance, we help companies anticipate and integrate these reforms into their operational strategies.

💡 Ready for change? Contact us to secure your compliance and optimize your processes!

+ The link to the newspaper article: https://lesoleil.sn/actualites/societe-fait-divers/la-pension-de-retraite-sera-etendue-aux-emigres/

Novallia was born one fine day in 2003!

2003 – Il était une fois…la rencontre de 2 expertises

20 years ago, Patrice Gabus and his partner set up their first engineering firm, MC2P.

The pioneering concept: combining legal and operational know-how, legal and engineering expertise. Initially focusing on environmental issues, the office grew rapidly and soon turned its attention to safety and industrial risks.

2007 – Growth, branding and training

After 4 years of significant growth, MC2P joined forces with 2 other design offices and created a new company. “Novallia Conseil & Formation”, the result of the merger of three specialist consultancies, is born.

🔵 The pretty name Novallia, a contraction of “new” and “alliance”, perfectly reflects the vision evoked. Novallia is an innovation-driven company, drawing on the skills and expertise of its employees to offer ever more effective solutions. A powerful vision even then, because these two attributes are still relevant today!

👉 Committed to working with manufacturers, Novallia’s primary mission was to control environmental, energy and human impacts and risks. This is achieved through consulting services and training courses.
👉 The founders are convinced that risk management is a major challenge not only for companies, but for society as a whole.

This new entity will rapidly be broken down into skill clusters: 🟢 Novallia Environnement, 🟡 Novallia Énergie and 🔴 Novallia Sécurité.

2010 – Innovation!

2010 marks a turning point in the history of #Novallia.
👉 Together with its partner Enablon, the company is developing the first web-based regulatory watch application. This revolutionary tool contains regulatory texts on Environment, Health & Safety, Industrial Risks, Public Facilities and Food Safety. It is regularly updated by Novallia engineers and supports them in their consulting services. The application is quickly catching on, as it makes the task of keeping up to date with regulations considerably easier for sites, whatever their ICPE classification or certification status.
📊 At the time, the tool already contained a statistical and control approach thanks to a series of indicators…
💻 The digital revolution is underway!

2011-2012 Novallia becomes a software publisher

The web application is attracting increasing interest from HSE managers, and Novallia is winning major contracts with key accounts such as EDF, LVMH, l’ORÉAL, GDF SUEZ…
2011 – It’s a magnificent year of growth, recruitment and abundance! A strategic direction was taken: reinvesting this handsome capital in R&D to develop our own application.
🗓 In 2012, the first web application developed by Novallia saw the light of day and was called NV SITE, at the time designed with IBM Cognos technology. A great adventure made of design thinking, web development, search for investors, UX and web design mobilizes the teams!

🌀 It was also in this year that Novallia adopted a new visual identity to accompany this change of strategy. For the visual identity, we had to move away from an image focused on the environment and broaden it to include the concept of digitalization.
A more “digital” image, but also a different way of communicating from our competitors. The concept: just because we’re talking about serious, serious things doesn’t mean we have to be sad about it. So let’s make way for illustration and color!

2014-2015 International expansion

Sales of the NV SITE web application have been exceptional, with the company posting 20% growth between 2013 and 2015! And it hasn’t faltered, despite internal storms between shareholders at the start of 2014… a situation often experienced by SMEs… Life goes on, and the NV SITE application continues to evolve thanks in particular to co-design – > Novallia invites its major customers to co-construct their application and suggest improvements. In this way, the regulatory watch tool is as close as possible to the concerns of its users.

Following a restructuring of the shareholder base and the company, Novallia adopted a new strategy, turning to international markets. The aim is to create structures to support our major groups, which are also international, in their foreign subsidiaries.

The parent company is transferred to Switzerland and the Tunisian entity is created. Novallia can now offer its customers the same services and tools in Switzerland, Germany and Austria, as well as in North Africa and sub-Saharan Africa.

Novallia’s units in Switzerland, France, Tunisia, Morocco and Senegal now employ more than 25 people who work closely together within a single organizational structure.

2016 – Evolution of the computer language of our NV SITE application

In 2016, Novallia developed NV Site 2.0, a new version in Angular language, revolutionary in terms of ergonomics and functionality. The tool focuses on multi-site management and its compliance & action plan modules. Because, of course, the whole point of digitizing regulatory monitoring is to be able to comply with any deviations from the regulations.
Novallia is also continuing its international expansion by setting up a subsidiary in Morocco in partnership with GQC, one of the country’s leading management systems consultancies.

2017-2019 Novallia, general compliance specialist…

Novallia’s initial focus was on controlling environmental, industrial and human risks, and it has gradually become a benchmark in the field of regulatory compliance. In recent years, she has extended her expertise to general compliance. The many uses of its web applications and the expertise of its engineers enable customer companies to manage their overall compliance with all kinds of requirements, notably normative – the famous ISO standards – but also their internal group requirements, or the action plans that follow an audit.
From 2017 to 2019, we will focus on improving the application, consolidating our services and our customer relations.

2019 – 2023 Opportunities from the COVID period to the present day

It’s clear that covid has had a huge impact on many companies, but it has also shown us the opportunities and paths we can take. For Novallia, this has meant a strengthening of regulatory expertise and associated consultancy. Indeed, during this period, numerous laws and regulatory adjustments were created to compensate for staff absences in companies. Novallia was at the forefront of ensuring regulatory compliance for its customers, and also shared this with its community in numerous articles and Linkedin posts.

A number of strategic areas were highlighted:

• Development of digital services: e-learning, webinars, site visits assisted by digital tools.
• development of the Swiss and African markets with the creation of a subsidiary in Senegal and the strengthening of the Swiss team
• web app improvements
• strengthening communication

It hasn’t all been smooth sailing, and after covid, in 2022, Novallia is facing new challenges on the IT side. The company bounced back by reinvesting time and resources in a new app called NV Compliance, and remains competitive, constantly at the cutting edge of technology.

Novallia is 20 years old this year, and we’re proud of how far we’ve come! Thanks for reading this far!

However, with the advent of new technologies and dedicated software, it’s logical to ask whether the use of a simple Excel spreadsheet remains effective and relevant for managing increased monitoring flows and dealing with all aspects of regulatory compliance.
It is now widely recognized that digitization, i.e. switching to a web application and databases, leads to considerable savings in terms of time and financial costs.

The advantages of Excel for regulatory monitoring and compliance

• Simplicity

  Microsoft’s office suite software is almost 40 years old, so it’s certainly easier for many people to work with this familiar spreadsheet program. What’s more, learning to use a new tool may discourage some employees, as it adds to their workload.

• Flexibility

  The well-known spreadsheet can be customized in a number of ways, giving the person responsible for regulatory monitoring a great deal of flexibility. In fact, the HSE manager will completely adapt his tool to his way of working. What’s more, the software makes it easy to review and correct these errors.

• The cost

  Integrated into Microsoft’s Office suite, companies who already have this license won’t have to invest in a new tool for regulatory monitoring.

The disadvantages of Excel software for regulatory monitoring and compliance

• The weather

  Time spent on Excel is a real problem when it comes to regulatory monitoring. In fact, designing a regulatory watch strategy in Excel is very time-consuming: there are many regulations, sometimes exceeding a thousand lines. The time spent on this tool can really represent a huge loss for the HSE watch manager, who is often alone, exhausted by this task and unable to attend to the other parts of his job.

• The risk of error due to the number of lines

  For a typical industrial site, environmental regulations combined with occupational health and safety regulations represent over 300 texts and therefore some 16,000 requirements to be examined. Each requirement is placed on a line in an Excel spreadsheet, and the HSE manager has to check his site’s compliance with each of these requirements. It’s easy to understand that the risk of error is high on a simple spreadsheet, where it’s easy to lose track.

• Lack of automation and overview

  Each requirement in the text has to be checked by hand, and each action plan to remedy the non-conformity also has to be created “manually” each time, wasting a lot of time for the person in charge. It is not possible to create scenarios or automate certain checks.

• Lack of overall vision

  It’s obvious that on a spreadsheet of over 15,000 lines, there’s a serious lack of overview and data consolidation, especially if the site belongs to a Group. Of course, it is possible to create associated graphics, but the work will have to be redone each time there is a change in regulations.

• Lack of real-time vision

  The Excel spreadsheet only takes changes into account when the HSE manager adds a regulation to the spreadsheet. Nor does it provide a real-time view of either work progress (number of requirements assessed) or site compliance, unless the HSE manager updates it every day, which is extremely time-consuming.

• Working together

  A simple Excel spreadsheet doesn’t enable effective collaboration between different employees or departments. The risk of multiplying versions is high, as is the risk of losing data or versions. While online collaboration can be a solution, there is sometimes the risk of error that remains with such a large file.
  What’s more, this tool and the extreme customization of the spreadsheet don’t make it easy to manage employee absences, particularly for vacations, or to pass on to new employees.

What are the alternatives to Excel today?

At a time when digitalization is taking hold in companies, there are many regulatory monitoring and compliance tools on the market.

A good regulatory monitoring and compliance tool will save you a considerable amount of time compared with Excel-based monitoring, thanks in particular to the automation of certain processes and regularly updated databases.

The last word…

Moving from Excel to a digitized solution is a major step forward in streamlining the work of the HSE manager. It’s a definite investment for the company, but one that will pay for itself in just a few months, thanks in particular to :

• saving time for the HSE manager,
• exhaustive lists of applicable texts
• productivity gains due to process automation: compliance assessment, action plan management, relevant and targeted extractions
• overview and real-time consolidation.

Among the many tasks of the “HSE Manager” function, there are those concerning regulatory monitoring and ensuring the company’s compliance with the various regulatory requirements.

On the subject of regulations, the main needs of HSE managers are as follows:

• know the regulations, follow their evolution and anticipate future changes
• distinguish which regulations apply to your company and its activities
• understand in detail the requirements of these texts and their implications for the company’s activities
• implement corrective measures and monitor their progress and site compliance.

The essential features of a good regulatory watch and compliance tool

• Centralize regulations: keep all applicable regulations in one place, with clear classification and searches by keyword or date.
• Automatic updates of relevant regulatory changes applicable to the company.
• Online help: internal chat, email, telephone
• Action plan automation
• Real-time monitoring of compliance actions
• Indicators and consolidation by site or group of sites (country)
• Customization (alerts, view levels, etc.)

Choose a free regulatory monitoring and compliance tool

To be honest, we haven’t found a regulatory monitoring and compliance tool or software package that’s completely free.

Free or inexpensive tools offer functionalities, of course, but certainly more in terms of regulatory monitoring than compliance. In particular, they help raise awareness of regulations and monitor the general, but non-targeted, flow of regulations.

[At Novallia, we offer a basic range of generalist regulatory watch bulletins, keeping you up to date with environmental, energy and occupational health & safety regulations on a monthly basis for French and European rights, and quarterly for other countries].

Of course, free tools also have many limitations.
Including :

• updates that are too far apart– sometimes 6 months, as opposed to a maximum of 2 weeks for NV Compliance – which means the company is unable to anticipate changes.
• no filtering of texts applicable to the company. And finding the applicable texts in all the texts is a major task.
• no follow-up and online help included in the price
• inability to export and import Excel files
• a lack of overview and consolidation
• no customization or parameterization possible

It’s tempting to turn to a free or low-cost monitoring and compliance tool. This may be a solution for small businesses with a very limited risk profile, but it’s clear that these tools will be limited in terms of functionality and support.

We’ve been developing our own applications for 12 years, combining the expertise of engineers & legal experts in the field and regulations with a high-performance SaaS application featuring many indispensable functions. This combination of expertise and development has a cost, but it also saves HSE managers an enormous amount of time and efficiency, and therefore money for companies!

It should be noted that the cost of digitizing this process pays for itself in just a few months.