Inadequate Storage and Back-up and no Correlation Between Electronic and Paper Records
Deviations are
Failure to store records so as to minimize deterioration, prevent loss and back up of automated data processing systems
The electronic data did not correlate with the paper records
You had not established an electronic data back-up procedure; and finally
Data was copied onto the server from one system to the next via floppy: therefore, no limited access or data protection had been established
There is no documentation associated with the electronic data, there was no audit trail capability; and finally, the electronic data did not correlate with the paper records.
Accuracy of Inputs to and Outputs from HPLC Instruments not Checked
The letter states:
“There was a failure to check for accuracy the inputs to and outputs from the Total Chrom Data Acquisition System, which is used to run your firm’s HPLC instruments during analysis of drug products.
“The chromatographic test data reflecting the out-of-specification test results were not recorded in laboratory notebooks. Instead, a new sample preparation was injected within the same chromatographic run without supervisory approval, as required by your firm’s SOP”.
Databases for Data Analysis and Other Tracking and Trending Functions not Validated
The Warning Letter stated:
Failure to have production and process controls for automated processes, when computers or automated data processing systems are used as part of production or the quality system.
A manufacturer is required to validate computer software for its intended use according to an established protocol. For example, databases that are maintained for data analysis and other tracking and trending functions, including complaint and services access databases, have not been validated for their intended use”.
Electronic Raw Data not Saved
The letter lists as primary deviations:
Operating parameters were maintained with the relevant xxx. However, electronic raw data was not saved.
Your firm failed to establish and follow an adequate written stability testing program design to assess the stability characteristics of drug products.
Storage condition for samples retained for stability testing are not adequately documented
The Quality Control Unit lacks adequate laboratory resources (personnel equipment) for conducting stability testing of drug products.
No Revalidation after Software Changes
According to the warning letter, the company failed to validate software for a device. The change in the software allowed for adjustment in the speed of the water pump, and inverse pulsing from the A valve to the B valve when the speculum was clogged. Your firm did not have any documentation showing that the current software version was validated”.
All Analysts and Supervisors have System Privileges
Deviations are.
The firm has failed to establish controls and procedures to assure authenticity, integrity and security of all electronic records including data generated in the QC laboratory.
No Backup Procedures and No Validation of Computer Systems deviations
The software programs do not secure files from accidental alteration or losses of data. The functions that modify and delete partial or whole data files are available for use by all analysts
There are no procedures for backing-up data files and no levels of security access established”,