FDA Warning Letter: You stated to our investigator that your software was not validated and lacked audit trails. (ucm614415)

This software is also used to document the completion of manufacturing steps on batch records, including [redact] amounts, manufacturing activities, and calculations. You stated to our investigator that this [redact] software was not validated and lacked audit trails.

In addition, your firm lacked adequate controls to ensure that actions are attributed to authorized individuals with unique and unshared login credentials. For example, our investigator observed that the login credentials of employee, [redact], were used to document the completion of several manufacturing activities on two drug product batch records dated March 17, 2021, and July 19, 2021. However, you stated to our investigator that [redact] has not been employed at the company since September 2019. Further, it was observed that login credentials including “[redact]” and “[redact]” were used to document the completion of several manufacturing activities. You stated to our investigator that these login credentials were shared by multiple employees. Shared login credentials are unacceptable, as this practice prevents the identification of specific individuals accessing a controlled system.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.

View the original warning letter.

FDA Warning Letter: “System/Administrator” was the only user role for your software.  The firm utilized a non-validated Excel spreadsheet and lacked a master validation plan for software.(ucm624281)

During the inspection, our investigator observed that many of your computerized systems lacked sufficient controls to ensure the integrity of the data being generated. For example:

• Our investigator found “System/Administrator” as the only user role for your [redact] software. There were no restrictions on deleting or modifying data for this user role. [redact] was used for assay and identity testing of finished thyroid, USP API from March 2021 to November 2021.
• Our investigator observed numerous deviations to original peak area results for HPLC assays of finished thyroid, USP API validation lots. There was no documentation of these alterations, but your quality unit personnel stated this may have been due to an unapproved update to the [redact] HPLC equipment. This equipment was never qualified according to your quality unit personnel.
• A non-validated Excel spreadsheet was utilized to calculate finished thyroid, USP API assay results for all validation lot assay calculations. The formulas and outputs of the spreadsheet were printed at the time of the calculation and not saved. You were unable to provide an electronic copy of the original spreadsheet or master spreadsheet during the inspection.
• Manufacturing master batch records held in electronic form on your company’s shared drive do not have restrictions on user access. Your quality unit personnel stated that there are no restrictions for any personnel with login credentials to access new and obsolete master records. Our investigator observed during the inspection multiple versions of batch records were utilized for API lot production.

View the original warning letter.

Warning Letter: Failure to Validate Manufacturing Process (ucm538424)

Warning Letter: Validation not documented (ucm489358)

There is no change control procedure or documentation for moving from Computer Numeric Control process.

Failure to establish and maintain procedures for changes to a specification, process, or procedures, as required by 21 CFR 820.70(b). Specifically,

On or about 5/12/2014, you had your contract manufacturer change from using Computer Numeric Control process to a hydroforming process to manufacture the ONE TRAY. You have not established process change procedures nor has this change been documented and verified/validated.

Your November 10, 2015 response cannot be assessed at this time. Your response states that you will fully document the validation activities performed to support the new manufacturing process; and will update your agreement with the contract manufacturer to address process changes. Please provide an update on the progress of these corrective actions.

View the original warning letter.

FDA Warning Letter: Validations of software processes not completed (ucm458487)

 
“”CAPA QS-13-006 identified corrective actions to your firm’s software validation procedure and identified 50 software processes that were not validated. Your firm closed the CAPA as effective on April 15, 2015; however, the validations for 38 of the identified software processes were not completed [Kurihara-shi, Miyagi].

The adequacy of your firm’s responses cannot be determined at this time. Your firm initiated a CAPA to address the above deficiencies. However, your firm has not completed implementation of its corrective actions and CAPA effectiveness verifications for this observation.”

View the original warning letter.

Mi Co User Days 2008

Validation of Mi-Forms User Forms – Ofni Systems president Ty Mew and Mi-Co CEO Greg Clary gave a presentation on the Validation of Mi Forms user forms on April 23 at Mi-Co User Days. The presentation focused on using Ofni Systems FastVal Document Generator to automate the process of validating Mi Forms user forms. Ofni Systems was a Silver Sponsor of Mi-Co User Days 2008. Ofni Systems is Mi-Co’s preferred vendor for validation services.

Research Triangle Park, NC

Get Started on your 2012 Validation Commitments

It’s a new year! Its time to prepare for regulatory and supplier compliance audits. But everyone in your department is already fully tasked and no one really has the appropriate validation experience. The FDA requires validation to document that GxP processes, computer systems, equipment and cleaning protocols are in compliance with all requirements. Failure to validate systems is one of the leading reasons a business is issued a 483.

Contact Ofni Systems and meet your Commitments

Computer System Validation Ofni Systems will validate all of your software, databases, spreadsheets and computer systems and develop the appropriate documentation for all phases of the software life cycle.
Process and Equipment Validation Ofni Systems will identify and describe your GxP processes and equipment, document and execute superior test protocols designed to demonstrate that your process meets all of your business and compliance requirements
Cleaning Validation Ofni Systems will document and test the most appropriate testing methodology for your business and regulatory needs.

Validation experts working for you

Validation should add value to your computer system or process. Ofni Systems will analyze your systems, identify the highest risk sections and focus testing appropriately. Our specialists are experts in industry standards and practices and will produce validation documents which will meet or exceed your exacting requirements.

Ofni Systems uses FastVal to execute Testing Protocols and focus testing, which allows us to complete higher quality validation projects with in 70% less time and with less cost than traditional validation methods.

Contact Ofni Systems and find out how our validation specialists can validate your computer system, equipment or process within your time and financial requirements.

Get Started on your 2010 Validation Commitments

It’s a new year! Its time to prepare for regulatory and supplier compliance audits. But everyone in your department is already fully tasked and no one really has the appropriate validation experience. The FDA requires validation to document that GxP processes, computer systems, equipment and cleaning protocols are in compliance with all requirements. Failure to validate systems is one of the leading reasons a business is issued a 483.

Contact Ofni Systems and meet your Commitments

• Computer System Validation Ofni Systems will validate all of your software, databases, spreadsheets and computer systems and develop the appropriate documentation for all phases of the software life cycle.
• Process and Equipment Validation Ofni Systems will identify and describe your GxP processes and equipment, document and execute superior test protocols designed to demonstrate that your process meets all of your business and compliance requirements
• Cleaning Validation Ofni Systems will document and test the most appropriate testing methodology for your business and regulatory needs.

Validation experts working for you

Validation should add value to your computer system or process. Ofni Systems will analyze your systems, identify the highest risk sections and focus testing appropriately. Our specialists are experts in industry standards and practices and will produce validation documents which will meet or exceed your exacting requirements.

Ofni Systems uses FastVal to execute Testing Protocols and focus testing, which allows us to complete higher quality validation projects with in 70% less time and with less cost than traditional validation methods.

Contact Ofni Systems and find out how our validation specialists can validate your computer system, equipment or process within your time and financial requirements.