Is Handwritten Raw Data required to keep with Electronic Records?

Q

QACen

#1
When documenting test data during any tests in the design controls, is it required to keep the raw data? Currently, engineers would hand write their observations and then transfer to an electronic format for the official, signed report.

From what I read in the medical device related regulations (13485 and 21 CFR 820/11), I don't see that it is a requirement and no one has said anything to us about keeping raw data in the last 10 years.

Reason asked is because we have a new engineer who came from a company who required that all raw data be kept with electronic records.

Thanks!
 
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Mikishots

Trusted Information Resource
#2
When documenting test data during any tests in the design controls, is it required to keep the raw data? Currently, engineers would hand write their observations and then transfer to an electronic format for the official, signed report.

From what I read in the medical device related regulations (13485 and 21 CFR 820/11), I don't see that it is a requirement and no one has said anything to us about keeping raw data in the last 10 years.

Reason asked is because we have a new engineer who came from a company who required that all raw data be kept with electronic records.

Thanks!
That other company may very well have had a requirement to keep raw data with electronic records, but there is no such requirement in the standard.
 

v9991

Trusted Information Resource
#3
When documenting test data during any tests in the design controls, is it required to keep the raw data? Currently, engineers would hand write their observations and then transfer to an electronic format for the official, signed report.
If i understand the logic, since raw data is being transcribed/entered into electronic system, raw data need not be retrained!.
despite making it transcription online&real-time, raw data which is manually recorded constitutes primary source of data)

the hand-written data constitutes the primary data, which records the exact observations as the activities are carried out. Just because, the values are transcribed into electronic system, does not take away the importance of primary&raw data.

part 11 guidance. Definition of E-record accomodating hybrid systems.
Records that are required to be maintained under predicate rules, that are maintained in electronic formatin addition to paper format,
and that are relied on to perform regulated activities

In some cases, actual business practices may dictate whether you are
using electronic records instead of paper records under ? 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record.

ref. definition of hybrid systems and
 

v9991

Trusted Information Resource
#5
I use a "Laboratory Notebook" to record test results and details. I then often refer in the Test Report to a dated entry in the Lab Book.

For control of the Lab Book I try to use the principles laid out in this article:

http://www.mddionline.com/article/good-laboratory-notebook-practice

Test reports are scrutinised by Notified Body and their CB test house and have not been a problem (so far !).
as i understand, OPs query is whether to retain the lab-book, or to discard once the transcription/reference is completed?

unless untill we have validated process of scanning the lab book, and making it part of the electronic note book, ; my recommendation was to retain the lab book, even though details are captured(transcribed, reviewed and approved) in the electronic book.
 

Pads38

Trusted Information Resource
#6
I would agree.
Part of the guidelines article I posted states that the Lab Book must be considered the company's property and be retained.
 
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