Spreadsheet


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Warning Letter: Computer systems not validated (s6381c)

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"Software used as part of the production quality system
was not validated
for its intended use according to an established protocol [21 C.F.R. 820.70(i)]. Specifically,
 
(a)
Spreadsheets
intended to check for outliers and calculate mean, SC, % CV, value assignments for finished devices.
(b) Complaint handling software
(c) Quantrol database program"

 

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Warning Letter: Failure to Validate MS Excel Spreadsheets (s6366c)

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Failure to adequately validate the intended use of this PC and its software, as required by 21 CFR 820.70(i). “For example: the dedicated PC [redacted] attached to the [redacted] was not secure in that access to the data on [redacted] was not granted by a unique username and password or equivalent method; there as no documentation associated with the electronic data for whom was responsible for collection of the analytical results as several quality control personnel have access to the [redacted] no software changes in the study data could be detected as there was no audit trail capability ; and finally, the electronic data did not correlate with the paper records.”

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Warning Letter: Failure to Create Validation and CAPA Procedures (g4452d)

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Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) and (b). For-example:

a. The procedure titled corrective Action Handling [redacted] was not approved and implemented to address corrective and preventive action and no established procedure was found to have been in place.

b. Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program.

A report dated November 11, 2002 on non-conforming material on [redacted] was filed and a possible cause for the [redacted] was given; however no documentation was provided to verify or validate the adequacy of the corrective and preventive actions.

Problems were recorded relating to the use of the new dosing/dispensing machine [redacted]; however no documentation/evidence was provided
to verify or validate the adequacy of the corrective and preventive actions.”

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Warning Letter: Spreadsheets not Validated (g5699d)

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There are no data to demonstrate that the quality control/quality assurance spreadsheets used for tracking and trending various quality metrics have been properly validated (installation qualification, operational qualification, and performance qualification) and are performing as intended.

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