The United States Food and Drug Administration (FDA) established regulations for electronic records and signatures in Title 21 CFR Part 11 of the Code of Federal Regulations. Effective since 1997 and updated several times since, Part 11 applies to industries regulated by the FDA such as pharmaceuticals, biotechnology companies, contract research organizations (CROs), and medical device manufacturers.

Part 11 specifies how these FDA governed industries must handle electronic records and signatures and defines the criteria under which they are authentic, reliable, and equivalent to paper records. The regulation requires implementing controls such as internal audits, audit trails, system validations, electronic signature protocols, and documentation for software involved in processing the electronic data that FDA rules require to be maintained. Failure to comply with Part 11 can result in FDA citations and fines.

Electronic records are a crucial aspect of modern business operations, encompassing emails, spreadsheets, and other digital files. Electronic documents, which are a subset of electronic records, play a significant role in records management by ensuring proper retention and organization to comply with legal standards.

Records and Information Management is considered as a companion discipline with enterprise data management, and shares many aspects of EDM / EIM.

Introduction to Electronic Records

Electronic records are a crucial aspect of modern business operations. With the increasing use of digital technology, organizations are generating vast amounts of electronic data, including emails, documents, and other digital files. Effective management of electronic records is essential for maintaining compliance, reducing risk, and improving operational efficiency. Electronic records management involves the systematic control of records throughout their lifecycle, from creation and storage to retrieval and disposal. By implementing a robust electronic records management system, organizations can ensure that their electronic data is accurate, secure, and easily accessible, supporting better decision-making and streamlined business processes.

Electronic Record and Electronic Signature Definitions

An Electronic Record is defined by Part 11 as “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” This definition ensures that electronic records are the same as paper records. It is important to distinguish between born digital and digitized records created within electronic records management, as each type requires proper organization, storage, and metadata management to address their unique characteristics and considerations.

An Electronic Signature is defined by Part 11 as “computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.” Part 11 contains requirements to ensure that electronic signatures have the legal standing equivalent to a person’s handwritten signature. Doing so ensures data integrity while reducing fraud and security concerns.

From a Records & Information Management (RIM) perspective, it is helpful to look at this regulation through the lens of ARMA International’s Generally Accepted Recordkeeping Principles® (GARP). The principles most relevant to Part 11 are Integrity, Compliance, Retention, and Protection:

Transitioning from Paper Records to Digital Records

Many organizations are transitioning from traditional paper records to digital records, a move that offers numerous benefits. Digital records enhance data security, increase efficiency, and reduce storage costs. However, this transition also presents challenges, such as ensuring compliance with regulatory requirements and managing the integrity of digital records.

To successfully transition from paper records to digital records, organizations should start by conducting a thorough inventory of their existing paper records.

Next, they should develop a clear plan for digitization, including selecting appropriate scanning technology and establishing metadata standards. It’s also crucial to implement a records retention schedule to manage the lifecycle of digital records effectively. Throughout the process, organizations must prioritize data security, ensuring that digital records are protected from unauthorized access and potential breaches.

Electronic Records Management Principles

  • Integrity – Part 11 demands that electronic records and information generated by or managed for the organization must have a reasonable guarantee and verification of authenticity and reliability.
  • Compliance – In order to comply with regulatory authorities like the FDA, Life Sciences organizations must have a Records & Information Management department (and for larger companies, an Information Governance program). There must be compliance with an enterprise’s own policies as well as with laws and regulations. In many organizations, policies may be coordinated with the organization’s data governance program.
  • Retention – There must be a clear records retention policy supported with validated tools and technologies that implement the policy. Part 11 does not expect companies to keep everything forever. Instead, organizations must consider the legal, regulatory, fiscal, operational, and historical requirements to determine retention with a records retention schedule, and then enforce it.
  • Protection – A reasonable level of protection is necessary for private, confidential, privileged, secret, and classified records and information. Protection also includes disaster recovery and business continuity planning (backups, off-site storage, etc.) which are not only a Part 11 requirement but also good business practice in any industry.

Electronic Records Management Systems (ERMS)

An Electronic Records Management System (ERMS) is a software application designed to manage electronic records throughout their lifecycle. ERMS provides a centralized platform for creating, storing, retrieving, and disposing of electronic records. It ensures compliance with regulatory requirements and industry standards, making it an essential tool for effective records management. Key features of an ERMS include automated workflows, audit trails, and robust security measures. These systems help organizations maintain data integrity, streamline document management processes, and enhance overall efficiency. When selecting an ERMS, organizations should consider factors such as scalability, user-friendliness, and integration capabilities with existing systems. A well-chosen ERMS can significantly improve the management of electronic records, ensuring they are accurate, secure, and easily accessible.

Types of Electronic Records

Electronic records encompass various forms of information created, modified, and stored digitally. These can include:

  • Born Digital Records: These records, such as word processing files and emails, are created in a digital format and require a computer system for access. Proper organization, storage, and metadata management are crucial for these records created to ensure their effective management and accessibility.
  • Digitized Records: Originally in a physical format, such as paper documents, these are converted into a machine-readable format through digitization processes like scanning, making them accessible as electronic files (e.g., scanned images and digital purchase receipts).
  • Complex Electronic Records: More advanced types, like databases or geographic information systems, store vast amounts of structured data and often include complex metadata for categorizing and retrieving information.
  • Metadata: Every electronic record contains metadata, which helps describe the file’s content, aids in evaluating and locating data, and ensures compliance with retention policies and access controls.

Implementing Electronic Records

RIM and Information Governance professionals in the Life Sciences must be aware and knowledgeable of Part 11 and other regulations to ensure compliance with the FDA regulations for electronic records. Proper retention and organization of electronic documents are necessary to comply with legal standards. Part 11 outlines the specific requirements and controls related to electronic records over the course of the information life cycle (planning, creation, modification, maintenance, retrieval and disposition/archiving). These guidelines and regulations differ from other industries, especially non-regulated ones where record keeping is primarily concerned with business use, however the requirements listed in Part 11 can be used as guidelines for non-regulated organizations.

The Part 11 regulation is applicable to records identified in predicate rules, such as Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). Records and Information Management professionals should be involved with the development and implementation of validated systems to ensure consistent intended performance, the ability to discern invalid or altered records, built-in retention management are characteristics of electronic records developed using the requirements found in Part 11. Benefits from the use of the regulation include accurate metadata management that is consistent with the corporate taxonomy, automation of processes where possible, and the development and implementation of audit trails that assure integrity, compliance, information protection, and appropriate retention.

Storing Electronic Records

Storing electronic records requires careful consideration of several factors, including data security, accessibility, and compliance. Organizations must ensure that their electronic records are stored in a secure and reliable environment, with adequate backup and disaster recovery procedures in place. Best practices for storing electronic records include using encrypted storage solutions, implementing access controls, and regularly updating security protocols. It’s also important to choose a storage solution that offers scalability and flexibility, allowing the organization to adapt to changing needs. By following these best practices, organizations can ensure that their electronic records are protected, easily accessible, and compliant with regulatory requirements.

Benefits of Electronic Records

Transitioning to electronic records offers several key advantages over traditional paper records:

  • Instant Accessibility: Electronic records can be accessed instantly from any location with internet connectivity, improving efficiency for remote teams and reducing delays in retrieving important documents.
  • Enhanced Decision-Making: Organizations gain access to real-time, accurate information, enabling faster, data-driven decisions that support critical business processes.
  • Data Analytics Capabilities: Electronic records integrate seamlessly with data analytics tools, allowing businesses to track trends, generate insights, and optimize performance by leveraging the vast amounts of information stored digitally.
  • Cost and Space Savings: Managing records electronically eliminates the need for physical storage, reducing associated costs and freeing up valuable office space. Electronic records management systems streamline record-keeping and compliance, reducing the cumbersome process of handling physical records.
  • Improved Data Security: With access controls, version control, and encryption, electronic records provide better security for sensitive information, ensuring compliance with regulatory standards and protecting against data breaches.

Security and Compliance

Security and compliance are critical aspects of electronic records management. Organizations must ensure that their electronic records are protected from unauthorized access, theft, and damage. They must also comply with regulatory requirements and industry standards, such as HIPAA, GDPR, and ISO 27001. Implementing effective security measures, such as encryption, access controls, and regular security audits, is essential for protecting electronic records. Additionally, organizations should establish clear compliance procedures, including regular training for employees and ongoing monitoring of regulatory changes. By prioritizing security and compliance, organizations can safeguard their electronic records and ensure they meet all necessary legal and industry standards.

Best Practices for Managing Electronic Records

To ensure the effective management of electronic records, organizations must adopt clear policies and utilize appropriate technologies. These best practices include:

  • Individual Responsibility: Every employee is responsible for maintaining records they create and receive, ensuring accuracy and compliance. This includes distinguishing between born digital and digitized records, and properly organizing, storing, and managing metadata for the records created.
  • Email Filing and Retention: Policies should guide email filing methods, with subject lines that support easy retrieval, and set retention periods to manage the information lifecycle.
  • Electronic Records Management System (ERM): Implementing an ERM automates processes, boosts efficiency, and enhances regulatory compliance by maintaining audit trails and ensuring data integrity.
  • Data Security Measures: A trustworthy system maintains at least two separate copies of critical records, safeguarding against data loss or corruption.
  • Mobile and Instant Access: Electronic records can be accessed instantly from various devices, supporting seamless collaboration and information retrieval.
  • Document Management Systems (DMS): DMS solutions help organize diverse file types, such as text files, spreadsheets, and presentations while controlling access through defined roles and permissions.
  • Training and Oversight: Regular training ensures users understand the system, while frequent checks verify that files remain intact and unaltered.

Conclusion

Every organization should consider the design, development, and implementation of appropriate electronic records to manage records and other content. Using the requirements found in the US FDA’s Title 21 Part 11 can give any organization the guidelines necessary to create and maintain appropriate electronic records.