Memo to File - Failure to Validate

kisxena

Starting to get Involved
#1
Hello:

I have a scenario in which I work in a distribution center that houses medical product in ambient, cold and freezing conditions that is shipped in the US and worldwide.

It was discovered that prior to placing product in their designated locations, the empty warehouse, walk-in cold room and walk-in freezers were not validated in an Empty state. However, they have been validated in Full condition prior to use. This applies to various locations throughout the US. As of July 2018, we have been validating Empty state prior to storing product.

It is not possible to remove the product in order to do an Empty state validation at this point. It was suggested that a equipment/location-specific addendum be written up for each one of the executed Full validations. I am suggesting that a Memo to File be generated to address all Affected Units and their locations were not validated in an Empty state prior to product being stored and that moving forward, all units & locations from July 2018 on would be validated properly. Then attach that memo to each validation in our electronic document management system.

Would my suggestion be acceptable by the FDA & ISO?

Please advise.

Thank you
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
Is conducting an empty state validation your requirements or is this driven by something else?

Regardless, I would recommend that any part of your remediation efforts include a risk assessment. What is the risk to the product currently stored (and distributed!) from not validating the empty state? If there's no risk then your approach sounds at least justifiable. If there is risk, it may be more difficult to justify.
 
Thread starter Similar threads Forum Replies Date
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
Z Internal Memo used to document work instruction Document Control Systems, Procedures, Forms and Templates 2
E Measuring Customer Satisfaction - Memo or a survey? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Stijloor Memo to bosses: Leave office, hit the streets World News 6
A Keeping the Usability File up to date IEC 62366 - Medical Device Usability Engineering 2
somashekar Medical device file Vs Role undertaken by the organization ISO 13485:2016 - Medical Device Quality Management Systems 1
A Supplier File info for large (Microsoft) companies. Medical Device and FDA Regulations and Standards News 2
H Regarding Usability Engineering File according to IEC 62366-1 CE Marking (Conformité Européene) / CB Scheme 2
S Risk Management File - Procedure Packs ISO 14971 - Medical Device Risk Management 3
G Similarities between format of technical file for CE and ASEAN common submission dossier template (CSDT) CE Marking (Conformité Européene) / CB Scheme 2
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Structure Technical File for a system EU Medical Device Regulations 0
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 9
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
K Design History File - Looking for Examples of DHF's. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
C European Technical File for registration in Australia CE Marking (Conformité Européene) / CB Scheme 5
V Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other ) Qualification and Validation (including 21 CFR Part 11) 0
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
P Letter to file or special 510k or traditional 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 5
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
Al Rosen Technical File - Updating Applied Standards EU Medical Device Regulations 4
K Identification of hazards and Risk file IEC 62366 - Medical Device Usability Engineering 15
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
G Same intended use devices - Technical file EU Medical Device Regulations 5
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 9
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
A Bookmarking my security protected IEC 60601-1 .pdf file IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
R No design history file or device master record ISO 13485:2016 - Medical Device Quality Management Systems 5
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 3
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14

Similar threads

Top Bottom