From Risk to Readiness: Winning at Electronic Record Compliance
- Alain Lai
- 1 day ago
- 4 min read
In today’s digital-first environment, electronic records have become a core staple in how organizations secure and manage their information. All industries must maintain electronic records in compliance with regulatory standards covering security and data privacy. As regulations continue to scale and businesses become more reliant on electronic data, the ability to seamlessly adapt to new compliance requirements impacting record-keeping is slowly emerging as a source of operational differentiation for many organizations.
Why Compliance Matters
Compliance in the management of 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, there is a risk of serious legal problems or financial penalties. In the worst-case scenario, there could be a forced termination of business or organizational activity.
Key drivers making compliance essential
Legal Requirements - There are legislative laws that must be followed, such as GDPR, HIPAA, PHIPA, 21 CFR Part 11, and Canada’s PIPEDA specify a number of operational requirements.
Readiness for Audit - Auditors and supervisors require access to complete and accurate records. Poor quality record keeping can be considered negligence, leading to client concerns and/or legal action.
Data Security and Privacy - With data breaches on the rise, more organizations are stepping up their use of encryption and tracking tools. What once was a forward-thinking priority is quickly becoming a necessary compliance control.
Business Continuity - Properly storing records ensures organizations can leverage past data and information during times of uncertainty or crisis such as in the case of a data breach or system outage.
Key Principles of Compliant Record Keeping
Authenticity and Integrity - Records must stay original and unmodified. To help ensure this, organizations typically employ tools like digital signatures, role-based access controls through systems, and tamper-proof audit trails that record every interaction.
Accessibility and Availability - Authorized users must be in a position to access records where necessary. The need for compliance at times is for retrieval within a set timescale, especially during audit or litigation.
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.
Audit Trails and Version Control - A system built for compliance keeps a detailed log of who made changes to a record, when those changes occurred, and what was modified. This version control not only ensures a clear history of edits to critical documents but also strengthens transparency and accountability.
Security and Role-Based Access Restricting - Access according to job functions is essential. Encryption (at rest and during transit) and multi-factor authentication protect from both internal and external danger. 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. Note areas where you lack adequate compliance with applicable law, for example, absent retention policies, insecure archives, or lack of audit trails.
Establish a Records Management Policy
Write a comprehensive policy that outlines:
i) What is a record
ii) Who is responsible for upkeep
iii) How records are stored, accessed, and retained
iv) When and how are they erased
This policy ought to be revised periodically and applies to all company departments.
Invest in a Certified EDMS Designed for Your Industry
An electronic document management system can simplify storage, retention, and compliance. Seek out ones 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 aspect of compliance that’s often overlooked is enforcing legal holds—essentially freezing specific records so they can’t be altered or deleted during audits, investigations, or legal disputes. Therefore, an effective system must have the function to pause automated deletion processes and record all activities during the hold. This function will allow for the safeguarding of evidence integrity.
Automation is an important part of keeping processes consistent and efficient. By automating activities such as classifying records and access control, organizations reduce the risk of human error and are able to provide consistent practices across teams. Thus, automated processes can therefore identify both a reduction in manual efforts by employees or business owners, as well as promote the proactive identification of compliance risks. In this sense, record keeping is no longer simply a reactive activity; it can be a proactive tool as well.
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 will have a significant impact on healthcare information sharing protocols.
Conclusion
Adhering to the requirements of electronic recordkeeping encompasses more than just compliance. It has value to the reputation of an organization, and their customers' trust. Compliance is a genuine value proposition for organizations 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 growing digital world of data.
Application to Research Data Management
All of these electronic record-keeping requirements and considerations apply to the RDM context. Principal Investigators (PIs), their teams, and their institutions are held 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.
World class RDM platforms like myLaminin support PIs and institutions to secure their research data, facilitate collaboration on that data, as well as 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 done. myLaminin is a blockchain-enabled RDM platform that supports the full RDM lifecycle - from data collection through to archiving and publication.
References
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Alain Lai (article author) is a myLaminin intern studying Business Administration at Wilfred Laurier University.
