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Topic: Will evolving beyond our paper-based record keeping systems lead to large expenses and fresh exposure to regulatory scrutiny?

posed by  Last edited: 21 April 2014 At 3:50pm
Our company fears that evolving beyond our paper-based record keeping systems will lead to large expenses associated with process revalidation and fresh exposure to regulatory scrutiny. Are these fears justified?
  • Avatar pharmamanufacturing Manufacturing Community Member 151 Posts

    Re: Will evolving beyond our paper-based record keeping systems lead to large expenses and fresh exposure to regulatory scrutiny?

    Trish Meek, product strategist, Informatics Business, Thermo Fisher Scientific:

    No, those fears are not justified. I think these fears are born out of experiences that happened in the past, but the technology has improved greatly over the past five years. The reality is that the cost of maintaining paper processes far exceeds the cost of integrating systems. The other fact to consider is the potential cost to quality [that stems from] not removing manual, paper based processes. The best a human being can achieve is four sigma for transcription activities. That means that for every 1000 results someone transcribes from an instrument they will make 3-6 mistakes. This error increases drastically to 3 per 100 if there is math or stress involved. If just one of these mistakes results in a batch being approved and then later recalled, or a failed FDA audit, the cost of this one mistake would far exceed the cost of the IT system that would have prevented it.

     

  • Avatar pharmamanufacturing Manufacturing Community Member 151 Posts

    Re: Will evolving beyond our paper-based record keeping systems lead to large expenses and fresh exposure to regulatory scrutiny?

    Last edited: 27 January 2014 at 4:52pm


    Lane Hirning, Product Manager MasterControl:

    Are the fears justified - yes and no. The expense of moving to an electronic system is reality but the benefits are also well known. There are expenses around the purchase, configuration, validation, and training of users on a new system. There is also the fear that the company will need to keep both the legacy and electronic systems active for some period of time with no clear ‘cut-off’ due to lack of confidence in the new system.

    I believe that this fear is based on the long deployment timelines for customized solutions of the past. The newer, truly ‘off-the-shelf’ software offerings and newer software validation strategies should overcome those fears. Software that is configured to the needs of the customer instead of customized is easier to implement, test, and validate. Configuration vs. customization decreases time to ‘go live’ and much of the ‘overlap’ of legacy and new electronic systems. Vendor executed Operational Qualification (OQ) and automated OQ testing decrease the time required for validation and allow managers to use risk-based decision making to only test the higher risk components and not waste time in lengthy validation efforts. I also believe that the current trends in IT virtualization will lead to easier, faster, and more trusted disaster recovery (DR) solutions which also bring about confidence in the new systems.

    Cloud offerings are beginning to be considered and, even with Pharma’s overwhelming intellectual property and security concerns, some applications will be appropriate for the cloud and allow for faster deployment and greater access. Software offerings requiring extensive validation may not yet be ready for cloud deployment but that problem is being working on by a number of vendors. The bottom line is that, both from the vendor side and the greater acceptance of electronic solutions by regulatory agencies, the move to the electronic solutions is not an ‘if’ but a ‘when’ and many of those regulatory bodies will start dictating timelines. The time is now.