US FDA et "Data integrity"...
La liste ci-dessous résume les récentes injonctions de l'agence américaine en matière de "data integrity":
Hospira, Mar 2013, Data Integrity
Puget Sound Blood Center and Program, April 2013, Lack of I/O Verification (Data Accuracy)
RPG Life Sciences Limited, May 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
Fresenius , Jul 2013, Unacceptable practices in the management of electronic data.
Agila Specialist Private Limited, September 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
Wockhardt Limited, Dec 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
Ranbaxy Laboratories, Inc., Jan 2014, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
USV Limited, Feb 2014, The computer system being used for quality control laboratory did not have adequate controls to prevent unrecorded changes to data.
Hospira, Mar 2013, Data Integrity
Puget Sound Blood Center and Program, April 2013, Lack of I/O Verification (Data Accuracy)
RPG Life Sciences Limited, May 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
Fresenius , Jul 2013, Unacceptable practices in the management of electronic data.
Agila Specialist Private Limited, September 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
Wockhardt Limited, Dec 2013, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
Ranbaxy Laboratories, Inc., Jan 2014, The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data.
USV Limited, Feb 2014, The computer system being used for quality control laboratory did not have adequate controls to prevent unrecorded changes to data.
