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Regulation Nation: Nine Principles for Managing Changes to Regulatory Documentation and Policies

  • People. Platforms. Progress.

Life sciences, insurance, energy, aerospace, telecommunications, finance – these are amongst the most heavily regulated industries worldwide. Navigating the constantly evolving market conditions and the sheer volume of regulations can make meeting business and compliance objectives a real challenge.

You might be hampered by obstacles that make it difficult to keep on top of the latest updates and operationalize them across your knowledge management systems, issues that make it difficult to:

  • Find and accessing content
  • Trace changes and redlines via email
  • Meet compliance objectives across jurisdictions
  • Track dependencies
  • Demonstrate how compliance is achieved
  • Move away from manual processes
  • Mitigate the risk of financial and reputational loss

Relying on spreadsheets and email to track regulatory updates adds to this risk as the high volume of data and rapidly shifting requirements are difficult to trace and manage.

Here are six steps your company can take to improve processes for managing changes to regulations and incorporating them into your internal company policies, procedures, and internal documentation.

If your organization is using generic solutions or PDF-based systems to create documentation, you might be juggling input from multiple Subject Matter Experts, external counsel and regulators, perhaps drowning in multiple final versions.

1. Centralize

If your company operates globally, with multiple offices across locations and functions, you might be using different systems to manage products, documentation and find it difficult to join up the dots on your data. One key step to centralization is having a single source of truth so your organization can manage global documentation in one place. Collaboration is achieved through workflow tools to manage edit and approval processes which helps prevents issues such as duplication and inconsistencies. Another key criterion is robust APIs that can provide seamless integration with other systems such as PLMs.

2. Content reuse and Linking Related Components

a) Content Reuse

It is not uncommon to hear that 40 – 60 percent of content is the same and reused in multiple locations. This not only increases duplication of effort, but also the risk of inconsistencies if your method of reuse is reliant on copy and paste. Implement a solution whereby you can reuse content across multiple locations with greater control.

b) Linking related content

Content and policies must manage the intricacies of remaining largely similar across multiple jurisdictions, but there will be specific instances where a component or paragraph has to be modified based on the jurisdiction or profile of the product/topic. Use content reuse automation where possible, and where a component slightly varies, link it to the master version so that you have better controls on change management.

3. Automating external monitoring

Your organization might need to comply with regulations and standards issued by multiple bodies across multiple jurisdictions. Manually tracking each update and incorporating them into your internal documentation not only has a high maintenance overhead, but there is also a significant risk of noncompliance. For example, if you are copying and pasting from the source material to a spreadsheet, there is no guarantee if it is accurate – it may be intentionally or inadvertently edited or it may become out of date as a result of an update.

It is not uncommon to hear that 40 – 60 percent of content is the same and reused in multiple locations. This not only increases duplication of effort, but also the risk of inconsistencies.

4. Rigorous change controls

As well as being able to control when external content changes, it is essential to have systematic change controls for managing internal material. For example, can you reuse content easily and manage different versions? What happens when something changes in a local or translated version of a policy?

5. Addressing collaboration challenges

If your organization is using generic solutions or PDF-based systems to create documentation, you might be juggling input from multiple Subject Matter Experts, external counsel and regulators, perhaps drowning in multiple final versions of documents with limited ability to keep track of edits made. Collaborating from a single source reduces the risk of duplication and inconsistencies.

6. Structured review and approval workflows

In order to demonstrate full compliance with standards and regulations, organizations in regulated industries can be challenged to present documentation, show traceability back to the source material, or substantiate actions taken to determine areas for improvement. Implementing structured review and approval workflows with a full audit trail of the process helps prove to regulators that you are in full compliance.

7. Improving findability

Policies and procedures might be buried in unnavigable systems such as SharePoint pages that have built up organically over time. At the heart of improving the findability of information is optimal tagging and use of metadata. This not only ensures that material is easily accessible but that filters can be applied, reports generated, etc.

8. Version control

Organizations must typically create multiple versions or outputs of the content for different sources. For example, one version may need to be published on a website and another submitted to internal or external systems. Leverage single source publishing to automate these processes which will reduce the turnaround time and manual effort at the end of the process.

9. Localization

Heavily regulated organizations that operate globally must often manage multiple languages. This increases the risk of inconsistencies and costs can rack up based on the level of review involved. Implement controls to identify exact components or paragraphs that require review when the master version is updated. This will enable you to reduce the manual review process, cut costs and export into translation solutions via APIs.
People. Platforms. Progress.
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