The Importance of Compliance in Electronic Record Keeping

Computer showing various digital folder options

In today’s digital-first environment, electronic records are essential for how organizations secure and manage their information. All industries must maintain electronic records in compliance with regulatory standards that cover security and data privacy. As regulations continue to evolve, businesses increasingly rely on electronic data. The ability to adapt to new compliance requirements is becoming a source of operational differentiation for many organizations.

Why Compliance Matters

Compliance in managing electronic records refers to the governing statutes and rules that regulate how records are created, stored, and disposed of. If organizations, businesses, or individuals fail to meet compliance expectations, they risk serious legal problems or financial penalties. In the worst-case scenario, this could lead to a forced termination of business or organizational activity.

Key Drivers Making Compliance Essential

• Legal Requirements: Legislative laws such as GDPR, HIPAA, PHIPA, 21 CFR Part 11, and Canada’s PIPEDA specify various operational requirements that must be followed.

• Readiness for Audit: Auditors and supervisors require access to complete and accurate records. Poor-quality record-keeping can be seen as negligence, leading to client concerns or legal action.

• Data Security and Privacy: With data breaches on the rise, organizations are increasing their use of encryption and tracking tools. What was once a forward-thinking priority is now a necessary compliance control.

• Business Continuity: Properly storing records ensures organizations can leverage past data during times of uncertainty or crisis, such as during a data breach or system outage.

Aisle in Records Storage Room

Key Principles of Compliant Record Keeping

1. Authenticity and Integrity: Records must remain original and unmodified. Organizations typically employ tools like digital signatures, role-based access controls, and tamper-proof audit trails to ensure this.

2. Accessibility and Availability: Authorized users must access records when necessary. Compliance often requires retrieval within a set timeframe, especially during audits or litigation.

3. Retention and Disposal: Each type of record has a defined retention period under law or policy. After this period, records should be securely destroyed. Automating these timelines can prevent possible errors and data security concerns.

4. Audit Trails and Version Control: A compliant system keeps a detailed log of who made changes to a record, when those changes occurred, and what was modified. This version control ensures a clear history of edits to critical documents and strengthens transparency and accountability.

5. Security and Role-Based Access Restricting: Access must be according to job functions. Encryption (at rest and during transit) and multi-factor authentication protect against both internal and external threats. System hardening provides additional support.

   
   

Best Practices for Regulatory Compliance

Conduct a Records Audit

Start with a comprehensive assessment of your existing records management system. Identify areas where you lack adequate compliance with applicable laws, such as absent retention policies, insecure archives, or lack of audit trails.

Establish a Records Management Policy

Write a comprehensive policy that outlines:

i) What constitutes a record

ii) Who is responsible for upkeep

iii) How records are stored, accessed, and retained

iv) When and how records are erased

This policy should be revised periodically and applies to all company departments.

Invest in a Certified EDMS Designed for Your Industry

An electronic document management system (EDMS) can simplify storage, retention, and compliance. Look for systems that include:

• Automated tagging and indexing

• Integrated retention enforcement

• Safe storage and backups

• Legal holds for litigation readiness

• Compliance with standards such as ISO 27001, SOC 2, and 21 CFR Part 11

  
  

Leverage Legal Holds and Automation

One often-overlooked aspect of compliance is enforcing legal holds. This essentially freezes specific records so they cannot be altered or deleted during audits, investigations, or legal disputes. An effective system must have the capability to pause automated deletion processes and record all activities during the hold. This function safeguards evidence integrity.

Automation is crucial for maintaining consistent and efficient processes. By automating activities such as classifying records and managing access control, organizations reduce the risk of human error. This promotes consistent practices across teams. Thus, automated processes can identify both a reduction in manual efforts by employees and promote the proactive identification of compliance risks. In this sense, record-keeping is no longer simply a reactive activity; it can also be a proactive tool.

Blockchain for Data Integrity

There is a rising trend in applying blockchain technology for time-stamped, immutable records, particularly in high-stakes industries like healthcare. These initiatives significantly impact healthcare information-sharing protocols.

Conclusion

Adhering to the requirements of electronic record-keeping encompasses more than just compliance. It adds value to an organization’s reputation and builds customer trust. Compliance is a genuine value proposition when good data stewardship practices, trusted access, and record integrity are important considerations.

Regardless of how or when regulations change, organizations will benefit from being transparent, consistent, and secure in their electronic record-keeping in an increasingly digital world.

Application to Research Data Management

All electronic record-keeping requirements and considerations apply to the Research Data Management (RDM) context. Principal Investigators (PIs), their teams, and their institutions must adhere to the same standards of responsible record-keeping. They are required to develop Data Management Plans (DMPs) that demonstrate adherence to all jurisdictional regulatory data security and privacy standards before they can begin their research. These plans are reviewed and must be approved by institutional Research Ethics Boards (REBs) and must satisfy all participants and institutional data security and privacy protocols.

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World-class RDM platforms like myLaminin support PIs and institutions in securing their research data, facilitating collaboration, and ensuring compliance with regulatory standards. It delivers the capabilities required to establish robust data security protocols, role-based access controls, PHI data management, encryption, multi-factor authentication, and audit trail requirements that are mandated irrespective of the nature of the research or where it is being conducted. myLaminin is a blockchain-enabled RDM platform that supports the full RDM lifecycle—from data collection to archiving and publication.

Additional Resources

For further reading on electronic document management systems, consider these articles:

• 7 Features of an Electronic Document Management System (EDMS) to Help You Boost Efficiency

• The Importance of Record Keeping

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Alain Lai (article author) is a myLaminin intern studying Business Administration at Wilfred Laurier University.