FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 1 of 11

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose.................................................................................................................................... 1

2. Scope....................................................................................................................................... 2

3. Responsibility........................................................................................................................... 2

4. Background.............................................................................................................................. 2

5. References............................................................................................................................... 3

6. Procedure ................................................................................................................................ 3

6.1. Record Identification...................................................................................................... 3

6.2. Recording and Error Correction .................................................................................... 3

6.3. Electronic Records ........................................................................................................ 4

6.4. Access........................................................................................................................... 4

6.5. Filing and Storage ......................................................................................................... 4

6.6. Record Retention .......................................................................................................... 5

6.7. Disposal of Records ...................................................................................................... 5

6.8. Archival of Documented Procedures............................................................................. 5

6.9. Other Quality Records................................................................................................... 5

7. Glossary/Definitions ................................................................................................................. 5

8. Records.................................................................................................................................... 6

9. Supporting Documents ............................................................................................................ 7

10. Document History .................................................................................................................... 7

11. Change History ........................................................................................................................ 7

12. Attachments ............................................................................................................................. 7

Attachment A - Laboratory Record Control Schedule.............................................................. 8

Attachment B - Requirement for an audit trail in laboratory records includes the following:.. 10

1. Purpose

To assure that records used by laboratory employees are properly managed. 

Records include reports, correspondence, quality records and technical records. 

Quality records include the following: internal audit reports, management reviews, 

corrective and preventive actions, etc. Technical records include data, forms, 

worksheets, control graphs, test reports, etc.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 2 of 11

For the most current and official copy, check QMiS.

2. Scope

This procedure applies to the Office of Regulatory Science (ORS) laboratories and 

laboratory work products and processes. This procedure directly concerns the 

laboratory’s quality assurance program and applies to the management of ORS 

laboratory records identification, collection, indexing, access, filing, storage, 

maintenance and disposal. Records may be either in hard copy or electronic form.

3. Responsibility

A. Laboratory Management

1. Verifies the accuracy of records.

2. Ensures employees are trained in record keeping policy and 

procedures.

3. Follows established record storage and disposal schedule.

B. Quality System Manager (QSM):

1. Maintains quality record system.

2. Ensures archival and disposal of quality records by record schedule.

C. Record Coordinator:

1. Oversees the management of unit records in accordance with ORAORM.018 ORA Records Management Program.

2. Conducts annual record inventory. 

3. Facilitates and ensure proper records maintenance, storage, disposal, 

retrieval, or transmittal (hardcopy and electronic); 

4. Monitor records control; at a minimum conduct or coordinate annual 

audit of records control processes within the assigned Center/Office and 

document results. Coordinate and/or issue request for corrective action. 

Records/records management audit may be conducted in conjunction 

with system, procedure or process audits. Reference SMG 2020; 

5. Participate and/or conduct local records management training.

D. Staff:

1. Responsible for following record management guidelines.

4. Background

None
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 3 of 11

For the most current and official copy, check QMiS.

5. References

A. ISO/IEC 17025:2017, General requirements for the competence of testing 

and calibration laboratories. Sections 8.4, 7.5, and 7.11

B. AOAC International Guidelines for Laboratories Performing Microbiological 

and Chemical Analysis of Food, Dietary Supplements, and 

Pharmaceuticals; An Aid to Interpretation of ISO/IEC 17025:2017; August 

2018.

C. SOP-000114, Control of Quality Records

D. SOP-000220, ORA Records Management Program

6. Procedure

6.1. Record Identification

A. Records are identifiable to the firm, product, person or event to which they 

pertain. Records are dated and identify the person who established the 

record.

B. Laboratory records contain sufficient information to maintain an audit trail 

(see Attachment B)

6.2. Recording and Error Correction

A. Electronic records within information management systems have audit trails 

to track changes and corrections.

B. All work performed is recorded legibly. Work is recorded in such a manner 

that another individual, competent in the same field, may repeat the work 

described solely from the description written without additional explanation.

C. Entries contain the date and initials or date and signature of the person 

performing each laboratory activity and reviewing data and results . 

Electronic entries in data recording systems such as Field 

Accomplishments and Tracking System (FACTS), Quality Management 

Information System (QMiS) or other electronic tracking system provide an 

audit trail.

D. If entries are not electronic, they are made in ink. No erasures or 

obliterations are made. Space not used are indicated with a line.

E. Corrections are made by drawing a single line through the incorrect entry, 

entering the correct information, and initialing and dating the change. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 4 of 11

For the most current and official copy, check QMiS.

Electronic entries in data recording systems such as an electronic tracking 

system provide an audit trail of changes.

F. Data or information is not discarded without explanation. Both original and 

amended data must be retained. To discard, the data or information is 

crossed out, initialed, dated and the reason for discarding indicated. 

Electronic entries in data recording systems provide an audit trail or require 

comments for data that is not used. 

6.3. Electronic Records

A. Electronic records and data files are backed up on a regular basis to 

safeguard against the loss of information due to equipment malfunctions or 

human error. 

B. Access to backup records are periodically confirmed and a record of the 

periodic confirmation is retained. See local procedures for specific policy, 

procedures, and schedules.

C. External labels of disk and diskettes or CDs are labeled to facilitate 

accurate filing and retrieval of electronic records. Examples of information 

that may be included on the label are:

1. subject or functional title which identifies the information,

2. inclusive dates of information contained on the diskettes or CDs, and

3. identification of the software program used to access the information.

D. Laboratories periodically confirm access to backup records according to 

local procedures.

6.4. Access

Access to records is restricted to prevent unauthorized use and amending of 

information. See local procedures for specific policy and procedures.

6.5. Filing and Storage

A. Records are kept on the premises and secured (e.g. in a cabinet or drawer) 

when not being actively used.

B. Records are stored in dry and clean locations. Storage areas and cabinets 

are labeled. Records may not be stored in obscure locations that are not 

identified. See local procedures for specific policy and procedures for how 

and where records are filed and stored

C. Analytical worksheets are submitted to the collecting program area and not 

stored by the analyzing laboratory in general. Electronic reports and records 

of laboratory data are maintained in the applicable web application, such as 

Field Accomplishments and Compliance Tracking System (FACTS), 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 5 of 11

For the most current and official copy, check QMiS.

electronic tracking system, Scientific Data Management System (SDMS), 

etc.).

D. Backup records are stored in a separate location from the original records.

6.6. Record Retention

A comprehensive description of FDA record retention policy is described in SOP000114 Control of Quality Records and SOP-000220 ORA Records Management 

Program.

A. Attachment A is the general laboratory records schedule.

B. Additional policy and procedure may be found in local procedures.

6.7. Disposal of Records

After the retention period has expired records are destroyed or transferred to an 

agency storage facility, for example, the Federal Records Center (FRC). Disposal 

of documents is in accordance with guidelines described in agency policy 

statements and directives.

6.8. Archival of Documented Procedures

A. Superseded and outdated laboratory operating procedures and work 

instructions (controlled copies), etc. are removed from accessible locations 

and archived. Records may be labeled as “Archived” or “Obsolete.”

B. Master lists are updated. 

6.9. Other Quality Records

Quality records (e.g. audit reports, reviews, function verification and preventive 

maintenance charts, quality control charts, corrective actions) are periodically 

archived. Best practice is to archive per calendar year or fiscal year. Local 

procedures should specify the schedule.

7. Glossary/Definitions 

A. Archive – process of moving records or electronic files that are no longer 

actively used or current to a location for retention for a defined period.

B. Records Cut Off is a file break, or ending of files at regular intervals, usually 

at the close of a fiscal or calendar year or when a case is closed. Records 

Cut Off is used to start the retention period for a record. 

C. Data file – A data file is related numeric, graphic or textual information that 

is organized in a strictly prescribed form and format. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 6 of 11

For the most current and official copy, check QMiS.

D. Electronic record – An electronic record is information recorded in a form 

that only a computer can process. Electronic records include numeric, 

graphic and textual information.

E. Form – A form is a document with a fixed arrangement of captioned spaces 

designed for entering and extracting prescribed information. Forms 

become a record once filled out.

F. Non-record – Non-records are copies of memoranda or letters sent to an 

office or an employee for information only and for whose filing or 

maintenance no one in the office is responsible.

G. Records – Records are materials created or received by an agency and that 

are preserved as evidence of the activities of the agency or for its 

information value.

H. Records Control Schedule - provides mandatory instructions and authority 

on how long to keep records (retention) and when they can be destroyed 

and/or transferred to alternate storage facilities or NARA Archives 

(disposition).

I. Retention time – Period or amount of time records are kept before 

disposal/destroyed or archival. Starts at the time the record cutoff has been 

reached.

J. Technical records – Technical records are accumulations of data and 

information which result from carrying out tests or calibrations and which 

indicate whether specified quality or process parameters are achieved.

K. Controlled copy – A controlled copy is a document that is numbered and 

issued to an individual, the contents of which will be updated after 

distribution.

L. Uncontrolled copy – An uncontrolled document is a document that is current 

at the time of issue but for which no attempt will be made to update it after 

distribution; document is marked “Uncontrolled Copy”. 

8. Records 

A. Field Accomplishments and Tracking System (FACTS)

B. Laboratory Information Management System (LIMS)

C. Quality Management Information System (QMiS)
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 7 of 11

For the most current and official copy, check QMiS.

9. Supporting Documents 

None

10. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.3 R 12/31/07 LMEB LMEB

1.4 R 6/6/08 LMEB LMEB

1.5 R 2/21/12 LMEB LMEB

1.6 R 03/25/13 LMEB LMEB

1.7 R 05/08/14 LMEB LMEB

02 R 05/15/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision 

# Change

02

Referenced ORA-QSM.002 and deleted the redundant statements from old revision. 

Removed staff manual guide reference. Added QMiS. Added reference to see local 

procedures for specifics of filing and storage.

Other revisions made as needed to align this procedure with new ISO/IEC 17025 and 

AOAC requirements. Revision to formatting and policy clarifications were made.

12. Attachments

List of Attachments

Attachment A - Laboratory Record Control Schedule .................................................. 8

Attachment B - Requirement for an audit trail in laboratory records includes the following:

............................................................................................................ 10
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 8 of 11

For the most current and official copy, check QMiS.

Attachment A - Laboratory Record Control Schedule

Laboratory and related records, retention periods, and disposal, are maintained as follows: 

Record Cutoff Retention/Disposal Schedule #

Purchase Records for 

transactions that exceed the 

simplified acquisition 

threshold

Final Payment

Destroy 6 years and 3 

months after cutoff FDA 9521a

Purchase Records for 

transactions at or below the 

simplified acquisition 

threshold

Final Payment

Destroy 3 years after 

cutoff FDA 9521b

(LIMS/FACTS, etc.) Program 

Database Records Include 

sample data, lab results, 

comments

End of Fiscal year after 

final action 10 years after cutoff ORA 3230

System Documentation 

(includes system & user 

manuals, data dictionary, 

requirements for ORA Reg. 

dBase Mgt. & support 

activities)

Temporary When superseded or 

obsolete ORA 3250

Violative Lab worksheets 

(Domestic)

End of fiscal year after 

reg. decision. 5 years after cutoff ORA 6120

Violative Lab worksheets 

(Imports)

End of fiscal year after 

re-exportation 5 years after cutoff ORA 4130

Non-Violative Lab 

worksheets 

(Domestic)

End of FY after 

regulatory decision 2 years after cutoff ORA 6110

Non-Violative Lab 

worksheets

(Imports)

End of FY upon release

2 years after cutoff ORA 4110

Pre-Market/Pre-Approval 

Lab Test Records 

(includes analytical 

worksheets, lab test results 

summary report, attachment 

for lab control documents for 

NDA, ANDA, NADA)

End of fiscal year after 

final action or analysis 10 years after cutoff ORA 6210

Lab test records not related 

to preapproval/premarket 

evaluations. (includes 

analytical worksheets, lab 

test results summary report, 

attachment for lab control 

End of fiscal year after 

final action or analysis. 5 years after cutoff ORA 6220
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 9 of 11

For the most current and official copy, check QMiS.

Record Cutoff Retention/Disposal Schedule #

documents not related to 

NDA, ANDA, NADA)

Shelf Life Extension 

Program (SLEP) raw data

End of calendar year 

when entire lot testing is 

completed.

10 years after cutoff ORA 2423

Lab QA Records (lab 

notebooks, instrument 

calibration, growth media, 

QC chart, Mgt Review, 

CAPA, DCRs, 

Complaints/Feedback, Audit 

Records, transmittal notices, 

etc.)

End of fiscal year after 

final action

3 years after cutoff FDA-4300

Method 

validation/verification 

records

Cutoff at end of FY 

when method is no 

longer used.

Delete/destroy 3 years 

after cutoff FDA-4300

Analytical

Training Records 

Cutoff: end of FY after 

employee leaves.

Delete/Destroy 5 years 

after cutoff FDA 4913

Check Sample Analytical 

Packages (Worksheets, 

printouts from analytical 

instruments, & other related 

records that show analytical 

findings.)

End of the fiscal year 

after the Final Report is 

completed.

Destroy/delete 3 years 

after cutoff ORA 6310

Final Check Sample Reports End of FY after Final 

Report completed

Delete/Destroy 5 years 

after cutoff ORA 6320

National Check Sample 

Program (NCSP) Annual 

Schedule

End of FY after 

completion of check 

sample analysis.

Delete/Destroy 5 years 

after cutoff or when no 

longer needed for 

reference, whichever is 

later

ORA 6330

NDA – New Drug Application

ANDA – Abbreviated New Drug Application

NADA – New Animal Drug application

QA/QC – Quality Assurance / Quality Control
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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 10 of 11

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Attachment B - Requirement for an audit trail in laboratory records includes the 

following:

A. Analyst(s) performing steps in the testing process

B. Analyst training → with traceability to Reference Materials (RMs) and 

proficiency checks

C. Calibration records → with traceability to suitable RMs

D. Column lot number

E. Equipment performance → (e.g., using CRMs, proficiency checks, and daily 

checks)

F. Equipment qualification and maintenance

G. Equipment used (see Note)

H. Media/Reagent identity

I. Media/Reagent open date when open date impacts expiration date

J. Media/Reagent/Reference material expiration date

K. Media/Reagent/Reference material laboratory assigned identification

L. Media/Reagent/Reference material lot number

M. Media/Reagent/Reference material received date

N. Prepared media/reagent preparation date

O. Prepared media/reagent preparer

P. Prepared reagent components

Q. Prepared reagent special instruction, hazards, or use restrictions

R. Reagent concentration/purity

S. Reports (mailed or electronic)

T. Results

U. Review of electronic transmissions [e.g., Laboratory Information 

Management Systems (LIMS) acquisitions)]

V. Reviews

W. Sample analysis (raw data including chromatograms, standard curves, etc.)

X. Sample handling and storage

Y. Sample preparation
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.13

Revision #: 02

Revised:

05/15/2019

Title: 

Record and Data Management Page 11 of 11

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Z. Sample receipt (log-in/check-in)