Harmonic Bionics

The ROI of a collaborative, configurable eQMS

Denis Machoka · Harmonic Bionics

In this story

Harmonic Bionics

Denis Machoka elaborates on the ROI derived from Unifize as a collaborative eQMS. He underlines that true ROI is reflected in compliance, data accessibility, and the defense of information. Denis commends Unifize's capabilities in showcasing regulatory control and its adaptability to adjust control levels based on data sensitivity.

SpeakerDenis Machoka
IndustryMedical Devices
Runtime1:51

Transcript

8 passages · 1:51
  1. 0:00

    On return to investment, Unifize gives you what you need. At the end of the day, the reason why you have a quality system is because you intend to be compliant.

  2. 0:11

    The return of investment is really compliance at the end of it. Are you able to be compliant? Are you able to answer the questions regarding your data? Are you able to access the right records in the right format? Are you able to defend the information that you have?

  3. 0:26

    If you're able to answer those questions to the regulators, that shows that your company is in control and the regulations require that you show control, Unifize provides you with that ability.

  4. 0:37

    It gives you the ability to determine what the level of control that you want to have. If some records and not that level, they don't need that level of control. You don't need to have that level control. You can.

  5. 0:49

    change the configuration to allow for that. Otherwise, if it requires that level of control and those are sensitive files governed by the predicate rules, then you can add more controls that will give you the level information you're looking for.

  6. 1:01

    terms of return to investment, at the end of the day, if you're a manager, you want to get there quickly, safely and compliance wise, you want to be compliant.

  7. 1:12

    Why would you take the longest difficult route to get there? I think if you can get there quickly, safely it’s the best way to go. I'm from a school of Lean Six Sigma. If you want to lean something out, you don't go indirectly. You go directly.

  8. 1:29

    And I think for those small size to medium size companies that are trying to get into this space, this is a no brainer to me. I think you can get there directly, quickly and safely.

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