Is it mandatory to provide the results of the validation report in handwriting?

[smdjohari]

Hi all,

I just want to know is it mandatory for us to provide the results of the validation report in handwriting? Currently, I join a new company and all results of the validation report is in handwriting. Thanks.

regards, smdjohari

 

[rob73]

Re: Validation report

As far as i know there is no requirements for the format or media of validation reports other than what is covered in ISO 13485 4.2.5
"records shall remain legible, readily available and retrievable. Changes to records shall remain identifiable"

 

[joylc]

At my previous employment any data collection sheets associated with the validation activities were attached to the validation report. The data sheets were filled out by hand as the testing was performed and were treated as records. Depending on the validation activity, the data sheets were sometimes summarized and typed up in the report, but the handwritten sheets were always kept as they were the original source of the data. We considered this a good documentation practice. Having the handwritten sheets attached also meant that the reviewer could ensure there were no transcription errors when the data was entered/analyzed.

In another area (incoming inspection) we had observation by a 13485 auditor who cited poor documentation practices when he observed testing results being recorded on scraps of paper which were discarded once the information was transcribed into an electronic record/computer form. After that we began retaining any handwritten data or directly entering the data into the computer for all areas.

 

[BoardGuy]

Hi all,

I just want to know is it mandatory for us to provide the results of the validation report in handwriting? Currently, I join a new company and all results of the validation report is in handwriting. Thanks.

regards, smdjohari

[FONT=&quot]Our friends in medical device have little different requirements than ISO 9001 and AS9100 in regard to handwritten document retention. Which standard requirements are applicable to your question[FONT=&quot]? [/FONT]Commercial (ISO 9001) and Aero/Defense (AS9100) typically are more interested in the formal reports that is legible.[/FONT]

 

[BradM]

I guess I would answer your question with a question...

What results are you talking about, and where do they come from?

If the results are screenshots, then obviously legible printed copies of the screenshots would be the results.

If the results are a computer printout, then that would be the results.

If it is observed data, then yes, that would be recorded on the appropriate form; reviewed; and submitted along with the results.

There may be a summary report of some kind that is generated from a computer. But typically this document has signatures at the end for approvals.

 

[Ronen E]

At my previous employment any data collection sheets associated with the validation activities were attached to the validation report. The data sheets were filled out by hand as the testing was performed and were treated as records. Depending on the validation activity, the data sheets were sometimes summarized and typed up in the report, but the handwritten sheets were always kept as they were the original source of the data. We considered this a good documentation practice. Having the handwritten sheets attached also meant that the reviewer could ensure there were no transcription errors when the data was entered/analyzed.

In another area (incoming inspection) we had observation by a 13485 auditor who cited poor documentation practices when he observed testing results being recorded on scraps of paper which were discarded once the information was transcribed into an electronic record/computer form. After that we began retaining any handwritten data or directly entering the data into the computer for all areas.

I completely agree on the retention side, however it's not necessarily expected that the raw data records be attached to the validation summary report (and I wouldn't expect an auditor on a routine audit to check the transcription, it's a bad use of their time; for-cause investigation is a different matter). Normally just an abbreviated summary of the results is included in such reports, or even just the outcome (with reference to the data collection methods and maybe location of the raw data records).

Cheers,
Ronen.