Paper generation for electronic records

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
#1

Hello everybody¡

We have problems with all the paper generation for our processes, we keep print outs of :

  • the sterililization processes in our plant (autoclaves, and buffer tanks, for examples)
  • all the data records generated by our Validator 2000 (more than five thousands pages a year).

We are attempting diminish or avoid generate all of these prints, we are thinking about doing a Validation of these electronic records.

Mainly I think if you print a summary of a sterilization process it doesn´t matter if you do that at the exact moment of the sterilization or few moments after an enquiry in a Inspection.

All of you, keep all these records?? Anyone of you have validated some print out generation? Anyone of you keep only the pdf´s instead of the print outs?

#2

we are in the process of going for a PDF converted document of all the paper records for the elecronically generated documents. apart from this you can also choose to store these on the server using some of the cots data management softwares.

#3
  1. Per Part 11, a validated computer system need not have paper printed at all.
  2. If you sign the paper after printing then your validated system would also have to have e-signatures.
  3. You can print, sign, scan the paper at low resolution, and then discard the paper.
  4. If you don’t need to sign the paper you can print directly to PDF eliminating the paper.
#4

Thanks all, for the answers,
the main problem we have is the consistency of all the difererent kind of diferent electronic records in the plant.

We have PLC´s, SCADA´s, dataloggers, Validator 2000, continuous records of pH, conductivity, etc. for each method we do the things diferents.

We are starting to believe in no print at all, Validator 2000 records, and burn a CD with the PDF records. Maybe in the future, it will be a problem in an audit, but nowadays we manage these records with Excel, and even sign the data records, we don´t have validated the Excel Spreadsheets for graph the data or for calculate the average, maximum temperature or Mean Kinetic Temperature.

If we break the CFR21 in a lot of points, why no in another one. Personally, I believe 21CFR11 is a imposible law, who only generate profits to IT companies and with a very poor implementation in factories.

#5

Aran,

I think you are right that you will be on shakey ground come audit time - we have just had an FDA audit and they went through MKT with a fine toothed comb to the point of proving the EXP function within Excel for the spreadsheets used to calculate it. It may also be worth considering the degradation of CD-R when opting for a storage medium. I have first hand experience of a CD-R archive becoming totally unusable after less than three years despite being kept in climate controlled conditions. CD-R was never intended as a long term storage medium and the degradation was physical - a strange sort of marbelling effect on the disks.

I agree with the notion that 21CFR is impractical but this doesn’t mean that it should be ignored, especially to the point of not bothering to validate calculation spreadsheets if they are being used in lieu of a 21CFR compliant system.

For a lot of our systems we use printing to paper and wet-signature to avoid Part 11 requirements, but you must remember to validate the print function of the software if this is the route you are taking.

Cheers

Monkey.

#6

I think if you print a summary of a sterilization process it doesn´t matter if you do that at the exact moment of the sterilization or few moments after an enquiry in a Inspection.

#7

You may print out an summary, but you should have the raw data stored in a save place where the data cannot be altered, deleted ore manipulated anyhow. The summary should be signed in respect of e eye peinciple and signed by the responisable persons.

Rgds gtf