An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM NO. 800.122

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: Electronic Recordkeeping and Compliance with 9 CFR Part 116

I. PURPOSE

This memorandum provides guidance to licensees and permittees that intend to utilize 

electronic records for documenting activities associated with the manufacturing of 

veterinary biological products.

II. BACKGROUND

Title 9, Code of Federal Regulations (CFR), part 116 requires complete accountability 

of all activities within each establishment. The records must be detailed and include, 

but are not limited to, items listed in 9 CFR 116. The regulations in 9 CFR 116 are 

suitable for both written and electronic recordkeeping. Licensees and permittees 

previously adhered to the regulations by printing out an electronic record and 

authenticating the paper document to satisfy the requirements of 9 CFR 116. This 

memorandum is intended for licensees and permittees that desire to utilize an electronic 

record system to document activities as required by 9 CFR 116; electronic 

recordkeeping that demonstrates controlled reliability, authenticity, integrity, security,

and usability are compliant with the requirements of 9 CFR 116. 

III. POLICY

A. Records are maintained on licensed premises unless an alternative location or 

an electronic service provider is authorized by the Center for Veterinary 

Biologics-Inspection and Compliance (CVB-IC).

1. The server used for storing the information, whether partial or complete 

information, must be maintained at the licensed or permitted site, or 

approved foreign manufacturing site in the case of imported products or 

other location(s) authorized by the CVB.

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave, SW

Washington, DC

20250
VETERINARY SERVICES MEMORANDUM NO. 800.122

Page 2

 An Equal Opportunity Provider and Employer

2. Alternatively, requests for utilizing an electronic service provider for 

electronic records may be submitted to the CVB-IC as an addendum to the 

plot plan legend. The request for utilizing an electronic service provider 

should include:

a. the location and identity of the electronic service provider;

b. the proposed process to audit the provider for compliance;

c. the audit of the provider.

B. The following types of record management controls are required to ensure that 

electronic information systems can provide adequate and proper documentation 

of activities for as long as the information is required by the regulations:

1. Reliability controls must be in place to ensure records adequately represent 

activities at the establishment. The electronic record generated represents 

the activity intended and is accurate, complete, and has not been altered 

inappropriately.

2. Authenticity controls must be in place to protect against unauthorized 

additions, deletions, alterations, or concealment. The record shall show the 

creator, the date and time, and alteration.

3. Integrity controls must be in place that allow audit trails providing evidence 

that records are complete and unaltered; access procedures to the system are 

in place and periodically audited.

4. Security controls must be in place to ensure access to the system and servers 

are controlled; access to the system by personnel not employed by the 

licensee or permittee is controlled and auditable.

5. Usability controls must be in place to ensure records can be located, 

retrieved, presented, and interpreted throughout the life cycle according to 

the regulations.

C. The electronic recordkeeping system is the responsibility of the licensee or 

permittee. Failure to comply with 9 CFR 116 may result in regulatory action.

IV. IMPLEMENTATION/APPLICABILITY

This memorandum is effective immediately.