Software Validation


Page 5 of 1012345678910
  1. Warning Letter: Failure to conduct complete validation (ucm255936)

    Tags: | |

    Failure to check input to and output from the computer or related system of formulas or other records or data for accuracy [21 CFR 211.68(b)]. For example, your firm went live with version 2.0.0 of the Hemocare Lifeline (HCLL) Donor Module on March 2, 2009, however, the validation of Module 15, Product Labeling, was incomplete in that it was not reviewed, accepted, or signed off by a responsible individual.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  2. Warning Letter: Lack of documentation (ucm253235)

    Tags: | |

    You have failed to establish and maintain a design history file (DHF) for each type of device you manufacturer that contains software. Specifically, the self-contained Triton models, the Classic Umbilical models, and the Designer Umbilical models. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements  of 21 CFR 820, (21 CFR 820.30(j)).

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  3. Warning Letter: Failure to validate (ucm257091)

    Tags: | |

    Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, your firm was unable to provide a documented design development timeline or work instruction for IMPAX CV 7.8.SU1 of the IMPAX CV 7.8 software design change that resulted in [redacted], approval for Global Release and Delivery on 7/30/2010.

    View the original warnng letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  4. Warning Letter: Failure to validate a change (ucm252701)

    Tags: | |

    Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation as required by 21 CFR 820.30(i). For example: Your firm issued an ECN (R9180) on July 7, 2009, which changed the revision of the controller software used in the 300B and 700B model scooters from revision #8 to revision #9. This change increased the motor resistance from [redacted]. There is no documentation to indicate that this change was validated/verified .

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  5. Warning Letter: Failure to validate CAPA effectiveness (ucm250065)

    Tags: | |

    Failure to adequately verify or validate that the corrective and preventive action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). …. design changes were approved, but no validation or verification activity evaluating the effectiveness of the corrective action was performed or documented. Failure to validate an automated data processing system used as part of the quality system, as required by 21 CFR 820.70(i). For example: a. The CPRPlus database used from 2006 to the present to track AEDs and conduct audits of tracked AEDs was not validated.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  6. Warning Letter: No documentation of software validation results (ucm247475)

    Tags: | |

    Documentation of all software validation results  for the i.v.STATION was not completed per your firm’s Design Control, (D R&D 33.00) and the Design and Development Planning (P R&D 01.01) procedures. For the [redacted]  software validation test, the output is to verify that the procedure was completed correctly and that the “bag contains the requested volume of the drug.” The test completion date and the volume of the drug were not recorded. Additionally, successful completion of the [redacted]software validation test is to verify “that the syringe contains the required volume of drug.” The completion date and the volume of the drug in the syringe were not recorded, per procedure, for this test as well.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  7. Warning Letter: System not validated (ucm243585)

    Tags: | |

    In addition, we remain concerned that your [redacted] adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation report (IVR) that is still not final. Critical issues (deviations) identified in your interim validation report during the inspection included the following, but is not limited to: lack of training for your [redacted] support team, incomplete SOPs and Work Instructions, and inaccurate data migration of legacy adverse experience cases from your previous adverse drug experience database, [redacted]. Currently, your [redacted] system does not display accurate clock dates on MedWatch forms for cases which were initially entered in [redacted] and later entered into [redacted] due to the receipt of additional information (follow-up) for the same cases. MedWatch forms printed out from [redacted] for these migrated cases are documented as initial 15-day reports, instead of follow-up reports. Also, the report date in Block B5 of the MedWatch form is the print date, not the actual date of submission. Shortcomings such as these affect the accuracy, reliability, consistency of the system and your firm’s ability to discern invalid or altered electronic records or make timely submissions to FDA as required.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  8. Warning Letter: Failure to validate computer software (ucm256890)

    Tags: | |

    Failure to validate computer software for its intended use in production according to established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented as required by 21 C.F.R. § 820.70(i). For example, your firm failed to validate, according to established procedures, the automated mills and lathes that are used in the manufacturing of components for the PL5 2008 medical laser. Your firm installed [redacted]automated mills and one automated lathe during December, 2006 but your firm could not provide an established validation protocol for the validation of the automated systems or provide any documentation that showed the systems and their controlling software that were used in the manufacture of metal and plastic components of the PL5 Medical Laser were validated. 5. Failure to establish and maintain adequate procedures for validating the device design that includes software validation and risk analysis, where appropriate, as required by 21 C.F.R. § 820.30(g).

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  9. Warning Letter: Software not validated (ucm239465)

    Tags: | |

    Failure to validate, for its intended use, computers or automated data processing systems used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm has not validated the software used for generating product labels.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>

  10. Warning Letter: Software has not been validated (ucm227058)

    Tags: | |

    The [redacted] Calibration Management software has not been validated as required by 21 CFR 820.70(i). This software is used to maintain equipment calibration records and calibration procedures. This same observation was made during the previous inspection of July 2006.

    View the original warning letter.


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>


Page 5 of 1012345678910