ORA Laboratory Policies
Food and Drug Administration
Each ORA laboratory has a control of records procedure for identifying, collecting, indexing, accessing, filing, storing, maintaining, and disposing of quality and technical records. Quality records include reports from internal audits, management reviews, corrective actions, and preventive actions.
220.127.116.11 Legibility, Storage, and Retention
Records are to be legible. Laboratory reports (recorded electronically or on FDA form FD-431 and FDA form FD-431a) are archived upon final review electronically or sent to the designated home district office for storage. Laboratory reports can be retrieved by requesting the report from the designated home district record management center. Electronic reports and records of laboratory data are maintained in the applicable web application, such as Field Accomplishments and Compliance Tracking System (FACTS), Laboratory Information Management System (LIMS), Scientific Data Management System (SDMS), etc). A record retention schedule is included in the laboratory’s procedure or in the SMG 3291.2, Field Office Filing System.
18.104.22.168 Security and Confidentially
Access is controlled in FDA facilities; only authorized personnel are allowed in the laboratory and record management center. Records are stored in secured areas. Records are confidential and redacted before release in accordance with Freedom of Information (FOI) requirements.
22.214.171.124 Electronic Records
Each ORA laboratory has a procedure describing the protection and back-up of electronic records. The procedure also describes the safeguards in place to prevent unauthorized access to or amendment of electronic records.
4.13.2 Technical Records
126.96.36.199 Retained Records, Audit Trail, and Identification
Laboratory reports, depending on the type of analysis, include the original observations, derived data, calculations, standard preparation, instrument printouts, and results. These reports are retained until closed in FACTS and/or LIMS and final review is performed. An electronic test report is in FACTS and/or LIMS. Staff records, equipment calibration, and verification reports are retained in accordance with the laboratory’s control of records procedure. The records contain sufficient information to establish an audit trail.
The records of each test contain sufficient information in order to repeat the test under conditions as close as possible to the original. This information includes factors that affect uncertainty and any environmental conditions that affect the test.
The collection report in FACTS identifies the personnel responsible for sampling. The FDA form FD-431a includes the identity of the personnel responsible for performance of each test and for checking the results.
188.8.131.52 Recording and Identification
Observations, data, and calculations are recorded at the time they are made and are identifiable to the activity performed. Method numbers and titles are used to provide traceability of records to activities.
When errors occur in records, each mistake is lined out, not erased, not made illegible, nor deleted. The correct value is entered, initialed, and dated. In the case of records stored electronically, equivalent measures are taken to avoid loss or change of original data.
- SMG 3291.2, Field Office Filing System
- Food Drug and Cosmetic Act, Section 301(j)
- 18 United States Code (USC) 1905, The Trade Secrets Act
- Each ORA laboratory has its control of records procedure. A template is provided. See Volume II, Section 1, ORA-LAB.4.13 Record and Data Management.
- ORA-QMS.002, Record Control