validation


Warning Letter: Failure to Validate Manufacturing Process (ucm538424)

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1.    Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example:
a.  Your firm did not validate the NeutraSal manufacturing process to ensure [redacted], as required per section 8.3.2 of your Equipment and Utility Validation Master Plan. For example:
i.  No Operational Qualification (OQ) or Performance Qualification (PQ) has been conducted to ensure [redacted].
ii.  The [redacted] processes were not validated.
iii.  Operating parameters have not been established for the [redacted].
b.    A validation summary report was not prepared as required by section 7.1.13 of your firm’s Equipment and Utility Validation Master Plan, after performing [redacted] and [redacted] different production room.
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Warning Letter: Validation not documented (ucm489358)

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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.

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

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“”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.”

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Mi Co User Days 2008

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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

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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

Tags:

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.