Regulatory Documents

What are regulatory documents?

Regulatory documents ensure compliance with regulations, standards, laws, and guidelines. They include various materials and documentation. Regulatory documents are critical in industries like healthcare, pharmaceuticals, and finance due to the laws, regulations, and standards imposed. Examples of regulatory documents include standard operating procedures (SOPs), quality assurance manuals, policies, and internal and external audit reports.

Disclosure management involves preparing, organizing, and presenting business data in a manner that meets regulatory requirements. Many professionals use disclosure management software to share reports and documents with key stakeholders like board members, executives, and managers. Disclosure management software also helps generate regulatory documents for auditors and institutions. 

Types of regulatory documents

Regulatory documents serve different purposes and vary by industry. Some of the common types of regulatory documents include: 

• Standard operating procedures: SOPs are detailed, step-by-step instructions that outline how to perform a task. They ensure compliance and consistency in how people perform their tasks and duties in the workplace.
• Audit reports: Internal and external audit reports are regulatory documents that assess an organization’s compliance. They also recommend the course of action a company should take to address any potential issues. Audits are critical in monitoring that organizations adhere to standards. 
• Protocol records: Protocols include specifics around the procedures and methodologies used in experiments, trials, and tests. They are most common in industries like healthcare and science.
• Compliance records: As part of their regulatory documents, organizations should retain compliance records. These include all of their training documents and records: bias and sexual harassment training, change control logs, and documentation associated with handling and addressing complaints and issues. 

Benefits of regulatory documents 

Regulatory documents play a crucial role across many industries and offer several benefits when maintained and organized. Primary benefits include: 

• Compliance assurance and legal protection: The most important benefit that regulatory documents offer is helping organizations adhere to local, national, international, and industry-related laws and regulations. They serve as a written framework for meeting requirements. Organizations may face penalties and fines if they violate them.. 

• Proactive risk management: Gaps and potential risks in how a task is conducted or performed may be identified by outlining policies, procedures, and standards. Proactively identifying and mitigating risks associated with business activities helps prevent future issues from occurring. 

• Consistent processes and procedures: Standardized processes ensure that operations are consistent. Documenting policies and procedures regularly leads to reduced variability in outcomes. This serves as a tool to ensure consistent practices as team members change over time.  

• Tools for knowledge transfers: Sharing knowledge in environments with rapid change, high turnover, and rapid growth can be challenging. Regulatory documents, especially SOPs and operational policies, help pass knowledge between individuals efficiently and minimize disruption during workload shifts. 

Challenges with regulatory documents

Creating and managing regulatory documents effectively isn’t always easy. There are certain challenges businesses need to be aware of, including:

• Building a structure that supports volume and complexity: Frequent updates to meet regulatory requirements can become complex and burdensome in certain industries and types of work. In such situations, leaders must consider managing numerous regulations and hiring the necessary staff and resources for the workload. 

• Managing interpretation and ambiguity: Regulatory language isn’t always clear-cut, and teams may encounter instances of ambiguous interpretation. This can potentially lead to compliance issues and legal violations. When in doubt, businesses should seek professional assistance to understand regulations accurately. 

• Interdepartmental collaboration and coordination: Creating robust and accurate regulatory documents is important. To do so, organizations must solicit input and assistance from multiple departments. Depending on the size and nature of the team, interdepartmental collaboration can be complex and increase the time taken to draft and complete documents. 

Best practices for maintaining regulatory documents

While the type of regulatory documents varies across business, industry, and location, organizations should follow general best practices for the best results. They include:

• Keeping up-to-date with relevant information: Businesses have the responsibility to keep themselves educated and informed about recent laws, standards, and guidelines that impact their work. They might consider dedicating a team or individuals across multiple teams, such as legal and human resources, to research the latest information.

• Standardize document formats and templates for consistency: Regulatory documents should follow a systematic and organized approach. Documents should always be clear to understand, easy for those with access to retrieve, and filed appropriately. 

• Review documents for accuracy and completeness: In addition to following a standardized template, regulatory documents must always be complete. Organizations may assign responsibility for regular document reviews to a specific individual or department to ensure frequent and consistent reviews. 

• Implement version control mechanisms: Regulatory documents can and should change over time as processes, policies, and procedures evolve. As a best practice, teams should implement a clear version control structure to track changes and quickly identify whether they are accessing the most recent file. 

Organizations use regulatory documents to meet regulatory reporting requirements. Learn more about the benefits and challenges of regulatory reporting.