Selecting the right compliance reporting system

What are the considerations and steps involved in choosing, implementing and using a regulatory compliance reporting system for the cosmetics and nutrition industries?

The decision to implement a new regulatory compliance system is not always easy, but there comes a point of realisation where current manual processes and efforts are too inefficient to continue, and a company cannot meet its growth goals without making a change.

That ‘aha’ moment of understanding this need for change is a key turning point, but where do you go from there? This piece will go over the different considerations, steps and lifecycles of choosing, implementing and using a regulatory compliance reporting system, geared towards the cosmetics and nutrition industries.

Define your goals

What are you trying to accomplish on a company level?

Before even considering a system, it is important to first understand your goals. What problems are you looking to solve within your team or department? How would this system line up with your company’s large-scale goals? Start broad before going into specifics.

Perhaps your company has new revenue goals it is trying to meet, and your department needs to run smoothly in order to obtain these lofty amounts. Or your company may be entering into countries it’s never sold in before and there is a goal to sell a certain number of products in a shorter time frame; this would affect your regulatory department, who’d need to ensure the compliance of all of these new formulas.

It is important to define these goals with your team and come up with a solid, well-supported list that you can reference later.

Although it is true that each company has a different focus, it is crucial to utilise your defined goals as the drivers to guide the criteria that you need in a regulatory compliance system in order to meet your commercialisation needs. Here are some examples of high level goals:

  • Get to market before competitors, by reducing time to launch by 50%
  • Reach company revenue of US$XXm next year
  • Add XX products in the next 12 months for X product lines
  • Expand into China and Japan/expand into nutrition.

What steps do you need in place to meet these commercialisation goals?

When looking deeper into choosing a compliance reporting system, it is valuable to outline the internal steps needed in order to meet your high level goals. What do you need to do within regulatory in order to meet these?

After all, you cannot sell your products if they are not compliant. Consider the nature of a compliance reporting system, and what you can accomplish with an automated system that acts as a single source of truth.

These details will allow for a more effective partnership with a system from the start.

For example, if your company’s goal is to reduce time-to- market by 50%, multiple internal processes may need to change, especially from a regulatory standpoint.

You will risk non-compliance or the inability to sell your products in certain regions if you do not create the necessary reports and checks for each product in time.

Consider the changes needed to reduce time-to-market while maintaining compliance for each formula. You most likely will need to increase your efficiency, improve communication and accessibility to all products and their documentation, automate compliance reporting and access accurate regulatory knowledge faster.

These are all actions a compliance system should enable you to perform. Below are more specific regulatory objectives for a compliance system:

  • Have quick access to global regulatory restriction data and rules, by jurisdiction, to be strategic with regulatory compliance and make informed decisions
  • Use a centralised repository that has all product, formula and raw material documentation, where attributes can be collected and stored for quick reference and reporting for improved cross-functional communication
  • Automate compliance reporting with the ability to generate compliance reports by formula, RM or INCI level substances with the click of a button
  • Easily access finished cosmetic goods, formula and raw material level data in order to review and report on the attributes within the data
  • Switch from a reactive to a proactive approach by staying ahead of changing and upcoming regulations.

In some cases, a system provider will have documentation to help you understand your own needs and steps further to guide you in this need-unveiling process.

What to look for in a system

Define your selection criteria

Once you have defined your goals and objectives, you can then determine the priorities of what you are looking for in a system – what criteria will you use to rank your providers? Here are some examples. But depending on your company structure, needs and goals, your list may vary:

  • Organised – a compliance system should improve the accessibility of your up-to-date documents and allow for quick information retrieval and reporting
  • Reduce manual work – an automated system should streamline processes, which may specifically include regulatory reviews, report generation, accessing updated regulatory information and more
  • Reporting – a system should be able to have the assembled product, formula, raw materials and ingredient level details broken down so that flexible, templated compliance reporting can quickly be accomplished
  • Document repository – a compliance system should have a quick view of your required documentation, along with a library of raw materials and their associated attributes. This information should be easy to view with clear dashboards
  • Single source of truth – a system should be the go-to location for compliance information and reporting, to minimise the multiple versions of documents saved in drives and be used as a centralised repository across departments
  • Accurate – a compliance system should allow you to stay up-to-date on the latest jurisdictional rules and regulations with minimal effort and with quick searchability
  • Usability – a user-friendly system allows easy navigation and high level visibility of processes with easy ways to communicate with teammates. A system should also be flexible enough to provide different user restrictions
  • Customer service/responsiveness – a compliance system should have a friendly support staff to assist with any system or regulatory questions that you may have; provide training; and partner with you on any future needs you have.

The right fit: The selection process

With your goals defined and criteria prioritised, it is time to research the compliance reporting software that best fits your needs. After your necessary calls, meetings and demos, consider the company that checks all your boxes.

It is crucial not to just settle for a software, but to make sure that you are partnering with the right team for your company – one that goes above and beyond to understand and meet your needs.

A compliance reporting system can be a large commitment, and it is important to know that you will be taken care of with prioritised service throughout the process, ample attention and training as needed.

Implementing a system

There is typically an implementation element involved with a compliance reporting system, as it allows the reporting capabilities to work for your specific documentation, formulas, ingredients, raw materials, attributes and more.

Expect a collaborative project ‘kick-off’ where you are assigned to a project team. Together you will review project planning and system design/tailoring if applicable, and set up a roadmap for implementation that includes regular cadence calls and predetermined timelines.

Typically, the process generally involves the following: data audit and cleansing, data load, configuration and training. Some implementations include an additional ‘custom development’ step.

Data audit and cleansing – After the implementation plan is in place, it’s time to prepare for your system provider to cleanse and load your data. This may include working with your provider to supply your data and identifying fields and items.

Collaborate any data clarifications with the system provider, and if you have specific goal-related metrics that you would like to track, make sure that you consider these when the fields are set up. Your system provider will then extract and cleanse the data.

Data cleansing includes finding the inconsistencies in your data and ensuring they are accounted for during the loading process. This ensures that the data is imported correctly into your system.

Data load – Once the data is reviewed and cleansed, your provider will get the back-end tasks in order, match your documents with objects, utilise different test environments and perform other quality checks as needed. Your information is then entered into your system and includes raw materials, blends, formulas, finished goods, associated documentation, and any other relevant information.

Configuration – Your instance will be set up according to the specifications originally agreed upon; this includes products purchased, user roles and assignments, and other details as needed.

Your provider may issue methods for tracking projects, perform additional tests to QC data and coordinate time for end user testing and support. At this time, final migration occurs and compliance reports are finalised.

Training – After your instance is configured, expect training in order to dive right into your instance. Training can include calls or meetings, screen shares, use cases and guides, among other documentation.

Partnering with your provider on training provides a seamless transition, that would also include an organised process to submit questions and address bugs, or other issues that arise.

Development – In some instances, partnering with your provider to build custom development may occur during or after completion of implementing the system. In these instances, your provider will work with you to determine the required design specifications for your company’s needs in order to produce additional features or functions to further help your team reach their goals.

FIGURE 1: Company z lifecycle

Case study: Company ‘Z’

Working relationship between company Z and Ithos Global from manual processes to continuous improvement

When company Z (a cosmetics brand) lost a key member of its regulatory team, it was the turning point for the company to look for a regulatory solution. Its processes were manual and with a reduced team it was challenging to review formulas for compliance and meet its strict product commercialisation deadlines.

Without a compliance reporting system, company Z lacked a single source of truth. It needed a document management system, and its approach to employee turnaround was reactive with complex training processes.

The company utilised manual reporting processes, and its regulatory review processes took an extensive period – the typical timeline was four weeks.

Company Z investigated regulatory compliance solutions to combat its current manual processes. Company Z searched for a solution that would be organised, able to report on formulas for compliance, have a document repository, act as a ‘single source of truth’, utilise the company’s own document templates and provide regulatory updates.

Company Z received presentations from other companies, matched each solution to its criteria and chose Ithos Global to be its service provider.

Life cycle of working with a compliance reporting system
Throughout its continued partnership with Ithos Global, company Z went through the following phases

Implementation – Company Z had a three- to five-month implementation timeline of the Ithos Information Network (IIN), where it provided its information and worked with the Ithos team to get up and running in the system. Weekly calls and training made this process seamless.

Incorporating IIN into everyday use – Company Z quickly started running reports in the system to understand the compliance status for the ingredients in its formulas. Time savings became evident from the start, and the company was able to output templated reports.

Newsletter and quarterly updates added – Ithos Global introduced a more comprehensive way of reporting on the regulatory quarterly updates of the Ithos Information Network, which enhanced the regulatory knowledge for company Z for current and upcoming regulations.

Yearly evaluation – At the one-year mark, company Z had the question “what more can Ithos automate within the system?” Specifically, company Z wanted to be able to keep track of and report on ingredient weights and calculate the total volume in the IIN in order to report for NICNAS, and to be able to view all raw materials by attributes in a side-by-side, comparative view.

Enhancements – Company Z worked with Ithos Global to add the requested features, and Ithos Global added RM comparison and import tracking capabilities to the IIN.

Continuous improvement – Company Z is continuously re-evaluating its needs and is continually growing its partnership with Ithos. On the horizon now are supplier outreach services.

With a compliance reporting system, company Z was able to reach the following outcomes with the Ithos Information Network:

  • Formulas, raw materials, documentation and reports are in one source of truth
  • A proactive approach to employee turnaround
  • More efficient training with reduced errors
  • Automated reporting with increased accuracy
  • On-the-spot regulatory assessments from ideation through to final formula approval
  • Shortened timelines: its regulatory assessment timeline was cut in half.

FIGURE 2: Implementation

Summary

When selecting a regulatory compliance system, it is important to understand your company goals as well as your department-specific goals, in order to get the most effective outcome.

Understanding where you are now and where you would like to be is crucial in deciding on a solution provider, and once you make that decision, it can be a continuous growth process upwards to meet your goals.

With the right system in place, you can significantly improve systems, reduce product launchtimelines and increase your ROI.

At Ithos Global, our focus is on solutions geared specifically to the cosmetics and nutrition industries. Find out how we can accelerate your time-to-market with our essential productivity- enhancing tools and extensive global regulatory knowledge.

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Ithos Global (more information, website)