Change Control & Enregistrements
Deux mises en demeures récentes de la FDA à l'encontre de deux sociétés réglementées montrent la pertinence et la précision des inspections récentes en matière de systèmes informatisés.
6. Failure to establish and maintain adequate procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example:
a. SOP-(b)(4) “Design and Engineering Changes” Rev (b)(4) states if a “software change affects the safety or effectiveness of the device, it must go through a full Software Verification and Validation prior to release to production. Otherwise, a limited Verification and Validation may be determined by the Engineering Manager and Regulatory Affairs Manager to be adequate.” Engineering Change Order (ECO) (b)(4), dated January 6, 2011, involves a change to the (b)(4) software, but your firm does not have any documentation of any software verification or validation activities associated with the change.
b. SOP-(b)(4) “Design and Engineering Changes” Rev (b)(4) indicates the Production Software List should include the most current version of the software approved for use and the revision date of approval, but the Production Software List does not include the revision dates of approval.
c) Your firm's quality control unit failed to conduct a complete investigation of issues related to the interface between your Regulated Software Collections Application (RSA) and BioMerieux Clinical Diagnostics BAC-T Alert computer systems. You therefore failed to ensure the satisfactory transfer of bacterial testing results of platelet products.
6) Failure to maintain records concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced [21 CFR 606.160 (a)(1)]. Failure of your distribution records to contain information to readily facilitate the identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s) the date of expiration or the date of collection, whichever is applicable, or for crossmatched blood and blood components, the name of the recipient [21 CFR 606.165(b)]...
b) The information in your irradiation logs does not match the processing records in your RAS computer system. For example:
i) The irradiation log shows unit # (b)(6) was irradiated from 13:36 to 3:40 but RAS indicates the unit was labeled as an irradiated product at 13:34....
Ces exemples montrent clairement l'importance que l'agence américaine accorde à l'exactitude, à la précision des enregistrements et au respect des bonnes pratiques applicables aux systèmes informatisés.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm315833.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313460.htm
https://docs.google.com/a/coetic.com/spreadsheet/viewform?fromEmail=true&formkey=dEV6Xy1zaUFOVno2SnJSRzF2Mzd0MEE6MQ
Notre site internet change de look, visitez-le à http://www.coetic.com/
La première porte sur la gestion du changement appliqué à un logiciel utilisé dans un dispositif médical :
6. Failure to establish and maintain adequate procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example:
a. SOP-(b)(4) “Design and Engineering Changes” Rev (b)(4) states if a “software change affects the safety or effectiveness of the device, it must go through a full Software Verification and Validation prior to release to production. Otherwise, a limited Verification and Validation may be determined by the Engineering Manager and Regulatory Affairs Manager to be adequate.” Engineering Change Order (ECO) (b)(4), dated January 6, 2011, involves a change to the (b)(4) software, but your firm does not have any documentation of any software verification or validation activities associated with the change.
b. SOP-(b)(4) “Design and Engineering Changes” Rev (b)(4) indicates the Production Software List should include the most current version of the software approved for use and the revision date of approval, but the Production Software List does not include the revision dates of approval.
La deuxième sur l'absence d'investigation sur des erreurs d'interface logicielle et sur l'horodatage erroné des enregistrements :
c) Your firm's quality control unit failed to conduct a complete investigation of issues related to the interface between your Regulated Software Collections Application (RSA) and BioMerieux Clinical Diagnostics BAC-T Alert computer systems. You therefore failed to ensure the satisfactory transfer of bacterial testing results of platelet products.
6) Failure to maintain records concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced [21 CFR 606.160 (a)(1)]. Failure of your distribution records to contain information to readily facilitate the identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s) the date of expiration or the date of collection, whichever is applicable, or for crossmatched blood and blood components, the name of the recipient [21 CFR 606.165(b)]...
b) The information in your irradiation logs does not match the processing records in your RAS computer system. For example:
i) The irradiation log shows unit # (b)(6) was irradiated from 13:36 to 3:40 but RAS indicates the unit was labeled as an irradiated product at 13:34....
Ces exemples montrent clairement l'importance que l'agence américaine accorde à l'exactitude, à la précision des enregistrements et au respect des bonnes pratiques applicables aux systèmes informatisés.
Pour en savoir plus:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm315833.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313460.htm
Sur nos actions préventives sur ces sujets :
https://docs.google.com/a/coetic.com/spreadsheet/viewform?fromEmail=true&formkey=dEV6Xy1zaUFOVno2SnJSRzF2Mzd0MEE6MQ
Notre site internet change de look, visitez-le à http://www.coetic.com/
