Electronic communication and record-keeping are great ways to save space and allow quick access to files, but it takes some effort to get the systems set up properly and to convert paper to e-files. In considering what type of system will work best for your organization, there are many items that must be kept in mind during the transition.
The following preimplementation checklist will help to reduce potential risks associated with electronic record-keeping systems.
- Validation: Record-keeping systems must be validated to ensure that the documents are truly valid (i.e. accurate, reliable, nonaltered documents).
- Readability: Must be able to print an accurate, legible, readable copy of the record.
- Access: Must take measures to protect items from unauthorized access.
- Protection/confidentiality: Must contain legally acceptable means to protect records.
- Retrievable: Must provide a means for easily accessible files and retrieval.
- Audit trail: Must use secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries to assist with validation.
- Backups: Provide a process for electronic storage, including procedures for labeling of electronically maintained records and a secure storage environment, including an off-site storage location.
- Quality assurance program: Regular review of the electronic record-keeping system, including periodic checks of the records.
- Disposal of originals: Properly dispose of the originals after they are transferred to an electronic record-keeping system. Documents that have legal significance or inherent value as original records (i.e., notarized documents, sealed documents) should be maintained as originals.
- Record retention: "Cleaning house" presents new challenges for electronic record-keeping if your files are not stored accurately or with enough detail to evaluate destroy dates. One consideration when storing files would be to store records via functional area, similar to how you store files today. Also, pull potential audit or legislative issues in a separate file for frequent evaluation.
With some forethought and planning, moving from paper-based to electronic files will reward you greatly with time and, ultimately, cost savings.
