THERMAL PRO CESSING 

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Module 24. Electronic Records 

and Signatures 

Thermal Processing for Meat and Poultry 

Products Training 

1 
 

 

Legal Status of Electronic Records and Signatures 

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 Electronic records and signatures are 

considered the legal equivalents of paper 

records and handwritten signatures executed 

on paper. 

2 
 

 

 

 

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Predicate Rules 

 A predicate rule is any regulation or law that 

includes a requirement to keep a record. 

 Look to predicate rule for 

• what records to keep 

• how long to maintain records 

• what signatures are required 

3 
 

 

 

 

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Electronic Record 

 An electronic record is any combination of 

text, graphics, data, audio, pictorial, or other 

information representation in digital form that 

is created, modified, maintained, archived, 

retrieved, or distributed by a computer 

system. 

4 
 

 

 

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Electronic Signature 

 An electronic signature is a computer data 

compilation of any symbol or series of 

symbols executed, adopted, or authorized by 

an individual to be the legally binding 

equivalent of the individual's handwritten 

signature. 

5 
 

 

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System Requirements: Validation 

 Has the system been validated? 

• Expect to test off-the-shelf systems where 

source code is not available 

• Expect full software validation for systems 

developed in-house or where source code 

is available 

6 
 

 

 

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System Requirements: Validation 

Confirmation and examination of objective 

evidence that systems conform to user needs 

and intended uses and that particular 

requirements implemented by a system can be 

consistently fulfilled. 
 

 

 

 

 

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System Qualifications 

 Installation qualification—meets codes and 

design specifications 

 Operational qualification—operates 

consistently within established limits and 

tolerances 

 Performance qualification—test the system to 

assure that it functions as intended. 

• This can be in the form of a series of 

challenges to make sure what is expected 

occurs. 
 

 

 

 

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Audit Trail 

 Does the system generate a secure, time 

stamped audit trail for each electronic record? 

 Does the audit trail show when a record was 

created, modified and deleted, and by whom 

and without obscuring previously recorded 

information? 

9 
 

 

 

 

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Electronic Signatures 

 Electronic signature mechanisms may be 

based on: 

• biometrics such as scan of retina, face or 

fingerprint, or voice recognition 

• two distinct components such as 

identification code or card and password 

10 
 

 

 

 

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Electronic Signatures 

 If a system employs biometric-based 

electronic signatures, is it designed so the 

signature mechanism cannot be used by 

anyone other than the genuine owner? 

11 
 

 

 

 

 

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Electronic Signatures 

 If system employs non-biometric signature 

mechanism, is the system designed so that 

• electronic signature mechanism can be 

used only by genuine owner? 

• attempted use by anyone other than 

genuine owner requires collaboration by 

two or more individuals (sharing cards)? 

12 
 

 

 

 

 

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Electronic Signatures 

 Is the system designed to: 

• allow the first of a series of signings during 

one continuous period? 

• allow signings during separate periods of 

access? 

• require use of all components of electronic 

signature mechanism? 

13 
 

 

 

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Electronic Signatures 

 Are electronic signature mechanisms: 

• unique to each individual signer? 

• not reusable by or re-assignable to anyone 

else? 

• linked to records, so they cannot be 

removed, copied, or transferred so as to 

falsify the record? 

14 
 

 

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Electronic Signatures 

 Do signed electronic records contain 

• printed name of signer? 

• date and time signature was executed? 

• meaning of signature (e.g., authorship, 

review, or approval)? 

 Is signature information readable in electronic 

display and printout? 

15 
 

 

 

 

 

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System Checks 

 Do operational system checks enforce 

sequencing of steps and events? 

 Do authority checks ensure only authorized 

individuals can use system? 

 Do device (e.g. terminal) checks determine 

validity of source of data input or operational 

instruction? 

16 
 

 

 

 

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Record Availability 

 Can the system generate complete and 

accurate copies in both human readable and 

electronic form? 

 Are records protected to enable accurate and 

ready retrieval throughout record retention 

period? 

17 
 

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Closed System 

 Closed system means an environment in 

which system access is controlled by persons 

who are responsible for the content of 

electronic records that are on the system. 

18 
 

 

 

 

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Open System 

 Open system means an environment in 

which system access is not controlled by 

persons who are responsible for the content 

of electronic records that are on the system. 

 Does the open system employ additional 

measures such as document encryption to 

ensure record authenticity, integrity, and 

confidentiality? 

19 
 

 

 

 

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Assigning Electronic Signatures 

 Is the identity of an individual verified before 

assigning an electronic signature? 

 Does the manufacturer assure the electronic 

signature is unique to the individual and not 

reused or reassigned? 

 Does the manufacturer assure that no two 

individuals have the same identification code 

and password? 

20 
 

 

 

 

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ID Code/Password Control & Maintenance 

 Are identification codes and passwords 

periodically checked, recalled, or revised? 

 Are transaction safeguards in place to prevent 

unauthorized use of passwords and/or 

identification cards? 

 Is system access limited to authorized 

individuals? 

21 
 

 

 

 

 

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ID Code/Password Control & Maintenance 

 For systems employing tokens or cards with 

identification codes or passwords: 

• Are tokens or cards tested initially and 

periodically? 

• Are loss management procedures in place 

and followed for missing or compromised 

cards or tokens? 

22 
 

 

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Training, Policies, & Procedures 

 Do those who develop, maintain, and use the 

system have the necessary education, 

training, and experience? 

 Have policies been established to deter 

record and signature falsification? 

 Have employees been trained in these 

policies? 

23 
 

 

 

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System Documentation 

 Is documentation of system operation and 

maintenance controlled and made accessible 

only to those who “need to know?” 

 Are there revision and change control 

procedures to maintain an audit trail regarding 

systems documentation? 

24 
Event Log Report Header For FMC FoodTech Customer 

Reep # Rectpe Descripti on 

216 Special Drink 

Controller # : 1 

.b.!m...Il£e!! II.in§ eb&u 

14: 11 :20 SensChck 

14:11 :23 SensChck 

14:11 :23 SensChck 

14:11 :23 Greetings 

14:14:01 Oper Entry 

14:14:09 Oper Entry 

14:14:18 Oper Entry 

14:14:18 Oper Entry 

14:14:21 Oper Entry 

14:14:25 HtWI Setup 

1<1:15·:oci · Loading 

14:16:59 Loading 

14:17:00 Loading 

14:17:00 Loading 

14:17:44 Vent 

14:18:52 Vent 

14:18:53 Come Up 

14:22:16 Come Up 

14:23:16 Come Up 

14:23:23 Come Up 

14:23:54 Come Up 

14:24:25 Come Up 

14:24:46 Come Up 

14:25:07 Come Up 

14:25:3B Come Up 

14:26:09 Come Up 

14:26:10 Cook 

14:27:19 Cook 

14:27:37 Cook 

14:28:10 Cook 

14:28:10 Cook 

14:28:39 Cook 

14:30:59 Cook 

14:31 :00 NumCool 

14:31 :52 NumCool 

14:31:53 NumCool 

14:32:00 NumCool 

Foodlcch 

Rec ipeCode 

216 

C ontainer Size 

16 oz Ball 

Process Time 

00:04:49 

Cycle#: 4 Process Date: 4/23/2007 

Log Description 

Begin Sensor Checks 

End Sensor Checks 

File version 0.0.0 .19 • Date 03·06-2007 

Beg.in i:-i"Qt Well Setup 

Begin Operator Entry Phase 

John Smith: Successfully Logged into Security 

Recipe Number Selected : 

lmmer Cook Spray Cool 

Alarm Acknowledged 

Begin Hot Well Setup 

Begin LoSding 

Product Code 

Batch Code 

End Loading 

Begin Vent 

End Vent 

Begin seQment 1 

At Steam O n Till Temp 

PID Switched 

Begin Segment 2 

Begin Segment 3 

Begin Segment 4 

Begin Segment 5 

Begin Segment 6 

Begin Segment 7 

End Come Up -Total C.U.T = 

Begin COok 

Alarm Acknowledged 

John Smith: Successfully Logged into Security 

MIG Entry 

Chart Entry 

Start Heat Recovery 

End Cook Phase 

Begin Segment 1 

End Heat Recovery 

Begin Hot Well Setup 

Begin Segment 2 

1 of 2 

Approved By : Jane Smith On 04/24/2007 16:58:34 PM 

P rocess Temp Initial T emp Start Date & Time En d Date & Time 

251 .0 °F 35.00 04/23/2007 14:11 :20 04/23/2007 15:00:02 

Print Date: 4/15/2008 

E!l!2U5.! Entry 

00:00:00 

00:00:02 

00:00:02 

00:00:00 

00:00:00 

00:00:08 

00:00:16 216 

00:00:17 

00:00:19 

00:00:00 

iio:cici :cio 

00:01 :59 123-456 

00:01 :59 TDFR123 

00:01 :59 

oo":oo,oo 

00:01:07 

00:00:00 

00:03:24 

00:04:24 

00:04:31 

00:05:02 

00:05:33 

00:05:54 

00:06:15 

00:06:45 

00:07:16 00:08:24 

00:00:00 

00:01:09 

00:01 :27 

00:01 :59 253.5 F 

00:02:00 253.0 F 

00:02:29 

00:04:49 

00:00:oci · 

00:00:53 

00:00:53 

00:01 :01 

TEMP 

98.71 

98.65 

98.84 

98.66 

98.72 

98.59 

98.58 

98.61 

98.60 

98.66 

98.44 

98.40 

98.46 

98.46 

97.96 

268.76 

268.78 

240.04 

252.91 

255.43 

254.95 

252.93 

253.03 

252.84 

253.03 

253. 15 

253.19 

253.49 

253.56 

253.30 

253.49 

253.49 

251.51 

251.53 

242.29 

242.29 

238.81 

~ 

0 .0 

0 .0 

0.0 

0.0 

0.0 

0.0 

0.0 

a.a 

0.0 

0.0 

0 .0 

0.0 

a.a 

0.0 

2.8 

28.0 

28.8 

27.2 

29.8 

29.4 

30.6 

31.6 

32,0 

32.0 

32.1 

32.1 

32.1 

32.0 

32.0 

32.0 

32.0 

32.0 

31.9 

31.9 

31 .5 

31.5 

31.9 

Print Time: 

RTD-2 RTD-4 

104.10 98.33 

104.1 l 98.30 

104.07 98.30 

104.09 98.30 

102.79 98.23 

102.79 98.23 

102.75 98.23 

102.73 98.20 

102.69 98.22 

102.69 98.20 

i ci2.52 98.14 

102.02 98.0l 

102.06 97.99 

102.06 97.99 

108:95 97.45 

234.06 ?68.22 

234.73 ?68.20 

243 .62 t39.59 

255.26 t52.40 

254.97 t55.43 

253.21 !54.12 

252.04 !52.29 

251.30 !52.28 

251.03 !52.22 

251.08 !52.33 

251.26 !52.52 

251.28 ?52.51 

251.73 !52.78 

251.79 !52.77 

251.84 !52.75 

251.85 152.72 

25 l. 87 152. 77 

250.50 !50.82 

250.51 !50.80 

229 .88 141.32 

229.88 141.32 

225 .98 137.67 

.ogTcc 

16:38:14 

fils:m: ~ RPM 

0 9 0 .00 

0 9 0.00 

0 9 0 .00 

0 9 0.00 

0 9 0.00 

0 9 6 .00 

0 9 6.00 

0 9 6.00 

0 9 0.00 

0 9 0 .00 

o 9 0 .00 

0 9 0.00 

0 9 0 .00 

0 9 0.00 

0 9 1.60 

1,496 62 18.30 .. 

1,595 63 18.40 

1,542 63 18.40 

1,398 65 18.40 

1,359 65 18.30 

1,429 65 18.40 

1,458 64 18.30 

1,453 62 18.40 

1,368 61 18.40 

1,404 62 18.40 

1,40 0 61 18.30 

1,443 61 18.30 

1,402 62 18.50 

1,417 62 18.40 

1,290 62 18.30 

1,266 62 18.30 

1,400 62 18.30 

1,164 36 18.40 

1,158 36 18.40 

852 22 18.40 

852 22 18.40 

888 21 18.30 

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Example Electronic Retort Log 

25 
 

 

 

 

 

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Paper vs. Electronic Records 

 Question: Can electronic records be archived 

as paper printouts only? 

 Answer: No. Records must be archived in 

electronic form, and the establishment must 

be able to generate electronic copies. 

Electronic records have meta data—date 

stamps, audit trails, and other information— 

not intended to be printed but important to 

audit. 

26 
27

Questions 

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Questions?