FDA 21 CFR Part 11
In the 1990’s, in order to promote a reduction in the quantum of paper used for attestation, the FDA( Food and Drug Administration, USA) established conditions related to the transfer of conventional paper- grounded records to electronic media. These came into effect in 1997. Electronic attestation is easier to falsify than paper- grounded attestation and so these conditions establish criteria for feting electronic records and electronic autographs as believable and of an equal standing to paper- grounded.
Table of Contents
FDA 21 CFR Part 11 Applies To The Following Pots
Pharmaceutical companies conducting business in theU.S. Companies furnishing products and raw accoutrements to these pharmaceutical companies Contract laboratories commissioned by these companies to perform analysis work
FDA 21 CFR Part 11 Applies To Records And Systems In The Following Cases
Cases where a PC is used to produce, correct, save, restore, and transfer data Cases where data is saved in electronic format exemplifications include logical instruments, balances, laboratory information operation systems( LIMS), electronic document operation systems, manufacturing operation systems, outfit control operation systems, manufacturing terrain covering systems, and entrance/ exit operation systems.
FDA 21 CFR Part 11 And Conditions
The particulars needed by FDA 21 CFR Part 11 are organized into sections.
Subpart A General vittles
compass
perpetration
Delineations
Subpart B Electronic Records
Controls for unrestricted systems
Controls for open systems
hand instantiations
hand/ record linking
Subpart C Electronic Autographs
General conditions
Electronic hand factors and controls
Controls for identification canons watchwords
The contents of these sections, still, aren’t veritably specific. Details can be verified by pertaining to other attestation, similar as the GAMP Guide. I’ll leave detailed explanations of each section to be covered in other attestation. Astronomically speaking, the conditions of FDA 21 CFR Part 11 can be distributed as follows Access control Data integrity Data security inspection trail Electronic hand confirmation
Shimadzu Corporation’s Response to FDA 21 CFR Part 11
At Shimadzu Corporation, in order to misbehave with FDA 21 CFR Part 11, we’ve suggested the following way Use Windows 2000 Professional or Windows XP Professional, which offer a high position of security. Increase the security position(e.g., access control and log functions) of customer software(e.g., IRsolution) that performs device control and dimension/ data processing. Use in combination with CLASS- Agent data operation software, which has database- operation and electronic- hand functions.
Store and manage all measured and reused data in the CLASS- Agent database. The following are also carried out confirmation of software and tackle Support and perpetration of installation qualification and functional qualification Support of system construction Taking the field of FTIR as an illustration, let us look at how we can misbehave with FDA 21 CFR Part 11.
Compliance with FDA 21 CFR Part 11 for Shimadzu FTIR Systems
In order to misbehave with FDA 21 CFR Part 11 when using a Shimadzu FTIR system, IRsolution software and IRsolution Agent software are used in combination. Both IRsolution and IRsolution Agent have high- position security- control functions, and measured and reused data is stored and managed in CLASS- Agent, which has high- position security functions.
1) Access Control
FFDA 21 CFR Part 11 demands the following with respect to access control
Access must be confined to authorized druggies.
Available functions must be confined according to the stoner.
It must be possible to change the word regularly.
There must be functions for precluding illegal access.
IRsolution and IRsolution Agent have a software security function that prompts the stoner for a stoner name and word at incipiency. druggies are divided into at least 3 groups( directors, Developers, Operators,etc.) and the functions that can be used by each group are confined. There are also functions for setting the validity period of watchwords, locking accounts, and automatically logging out, which can be used to help illegal access.
2) Data Integrity
FDA 21 CFR Part 11 demands the following with respect to data integrity
FDA 21 CFR Part 11 demands the following with respect to data integrity
With IRsolution, in addition to information on the dimension conditions, times dates, the stoner name, and device names, interferograms, which represent the real” raw data”, are recorded and stored together in data lines( vessel lines). Also, because all data is stored together in vessel lines after data processing, raw data and incompletely reused data can be recovered from reused data. Also, all measured and reused data is automatically stored in the CLASS- Agent database, which has high- position security functions, and is thus reliably defended from falsification and corruption.
3) Data Security
In FDA 21 CFR Part 11 systems, tried raw data must be reliably defended from omission, overwriting, revision, and accidents. With IRsolution, all measured raw data is automatically stored in the hard fragment. omission and overwriting of data is banned and so the loss of data due to processing or accidents is averted.
4) inspection Trail
FDA 21 CFR Part 11 demands the following with respect to inspection trails An operation log for bias that includes information on logon exertion and details of operations must be recorded. With IRsolution and IRsolution Agent, a history of operations, including stoner names and details on measures and data processing, is recorded and displayed in the operation( system) log. The times and dates at which measures are performed and details of the data processing carried out are recorded in the data log.
5) Electronic hand
FDA 21 CFR Part 11 demands the following with respect to electronic autographs
Electronic autographs are unique to individualities and mustn’t be reused by or reassigned to other parties.
There must be at least two identification factors(e.g., an ID and a word).
inked electronic records must contain hand information detailing the full name of the signer, the time and date of the hand, and the reason for signing. Electronic autographs must be linked to the electronic records to which they apply. here must be mechanisms for precluding the use of autographs to disguise electronic records. Electronic autographs are used with IRsolution. Electronic signing requires the input of a stoner name and word.
6) confirmation
FDA 21 CFR Part 11 demands the following with respect to confirmation confirmation is needed for rudiments that may affect the results of trials, similar as tackle and software.
IRsolution and IRsolution Agent are equipped with an revision check program that can be used to check whether or not software has been installed rightly. confirmation of tackle(e.g., IRPrestige- 21 or FTIR- 8400S) is performed with a confirmation program that complies with the Japanese and European Pharmacopoeia and ASTM. There’s also support for the installation qualification and functional qualification that’s carried out at installation and in periodic examinations.
