PART 11 -- ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart B - Electronic Records
Sec. 11.10 Controls for Closed Systems
In today&39;s digital age, the management and maintenance of electronic records play a crucial role in various sectors, ensuring accuracy, reliability, and compliance with regulatory standards. To uphold the authenticity, integrity, and confidentiality of electronic records, it is imperative for individuals and organizations utilizing closed systems to implement robust procedures and controls. These measures are designed to prevent tampering, unauthorized access, and the repudiation of signed records.
Validation of Systems:
First and foremost, it is essential to validate systems to ensure accuracy, reliability, and consistent performance. This involves confirming the system&39;s ability to discern invalid or altered records effectively.
Generation of Accurate Copies:
Furthermore, systems must have the capability to generate accurate and complete copies of records in both human-readable and electronic formats. These copies should be suitable for inspection, review, and copying by relevant agencies.
Protection and Retrieval of Records:
Records should be protected to enable accurate and readily retrievable access throughout the designated retention period. This ensures that records remain intact and accessible when needed.
Limiting System Access:
Access to systems should be restricted to authorized individuals only, minimizing the risk of unauthorized alterations or breaches.
Use of Secure Audit Trails:
Secure, computer-generated, time-stamped audit trails are indispensable for documenting operator entries and actions related to electronic records. These audit trails should accurately record the date and time of all pertinent activities without obscuring previously recorded information.
Operational System Checks and Authority Controls:
Operational system checks and authority controls are necessary to enforce permitted sequencing of steps and events. Additionally, authority checks ensure that only authorized individuals can access, modify, or electronically sign records within the system.
Device Checks and Personnel Qualifications:
Device checks validate the source of data input or operational instructions, ensuring the integrity of the information. Moreover, individuals responsible for developing, maintaining, or using electronic record systems should possess the requisite education, training, and experience to perform their duties effectively.
Establishment of Written Policies:
Written policies should be established and adhered to, holding individuals accountable for actions initiated under their electronic signatures. This serves as a deterrent against record and signature falsification, promoting transparency and integrity.
Controls Over Systems Documentation:
Lastly, appropriate controls over systems documentation are essential. This includes regulating the distribution, access, and use of documentation for system operation and maintenance, as well as implementing revision and change control procedures to maintain an audit trail of system documentation development and modification.
In conclusion, adherence to these guidelines and controls is crucial for safeguarding the integrity and reliability of electronic records within closed systems. By implementing robust procedures and controls, organizations can ensure compliance with regulatory requirements, mitigate risks, and maintain the trust and confidence of stakeholders in the digital era.