tacitus. charlie gragg ceo software engineering applications solutions, inc
TRANSCRIPT
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“Reason and judgment are the qualities of a leader. “
Tacitus
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Compliance to theLetter or to the Intent?
Charlie GraggCEOSoftware Engineering Applications Solutions, Inc.
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Agenda
What Compliance is Is Compliance working How does your organization view
Compliance Compliance degree examples Moving from “Letter” to “Intent” Thoughts and Questions
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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What is Compliance?
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Compliance Definition (Wikipedia)
Conforming to a specification or policy, standard or law that has been clearly defined.
Describing the goal that corporations aspire to in their efforts to ensure that personnel are aware of and take steps to comply with relevant laws and regulations.
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Compliance Definition (Layman)
Having policies in place to meet regulatory requirements
Having documented procedures describing how to work within those policies
Following the documented procedures that are in place
Documenting that we followed the procedures
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Compliance is the
Basic (Minimum) level of activityStarting point for Customer
SatisfactionBasic Framework for Business Success
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Is Compliance Working?
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Total Product Life Cycle: Infusion Pumps— Premarket Notification
56,000 reports of adverse events related to infusion pumps between January 1, 2005, and December 31, 2009
Many of the pump problems appeared to be linked to faulty design such as: Software error messages Human factors Broken components Battery failure
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Is Compliance Enough?
If you follow all traffic laws you will never have an accident
If you meet all college graduation requirements you will be successful
If code passes Unit Testing, it will work
If you successfully complete V&V, you will never have a product complaint
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Your Organization and Compliance
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ComplianceDoes Your Organization?
Follow itUtilize it for improvementEmbrace or Minimize itRationalize Doing or Not Doing itAdvocate it is needed or too time
consumingTake the Quickest Path to Satisfy or
Gain Value
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Degree of Compliance Examples
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Compliance Experience With
21 CFR §820.20 Management ResponsibilityManagement Review
21 CFR §820 .25 PersonnelTraining
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Management Review 21 CFR §820.20(3(c))
Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of the quality reviews shall be documented.
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Management Review
Activity
Letter IntentReview of effectiveness at defined
intervalsSatisfies requirements of Compliance
Results documented and datedFollow-up of action items documentedDefined relevant agenda
Agenda pre-distributed
Defined and appropriate attendees
Documented feedback and follow-up
Yes Yes
Yes Yes
Yes Yes
Unknown Yes
Unknown Yes
Unknown Yes
Unknown Yes
Unknown Yes
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Training21 CFR §820.25(b)
Each manufacture shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
Training shall be documented. Personnel shall be made aware of device
defects which may occur from the improper performance of their specific jobs.
Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Training
Activity
Letter IntentAligned to job function
Documented
Knowledge of process risks & defects
Level of employee understanding
Updated as necessary
Employees tested for comprehension
Duties restricted if non-compliantCertification required upon compliance
Yes Yes
Yes Yes
Yes Yes
Unknown High
Unknown Yes
Unknown Yes
Unknown Yes
Unknown Yes
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Your Organization’s Audit Preparation
Letter or Intent?
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Your Examples - Good and not so Good
To the Letter To the Intent
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Letter or Intent?
Activity
Letter IntentReserve audit room
Setup back office
Verify and circulate SME list
Update audit procedure as necessaryComplete outstanding M/R action itemsReview and update CAPA’s as necessaryReview and update training as necessaryCheck and update procedure references
Yes Yes
Yes Yes
Yes Yes
Unknown No
Unknown No
Unknown No
Unknown No
Unknown No
Review and update DHF documents
Facility readiness walk through
Unknown No
Unknown NoSoftware Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Moving from the Letter to the Intent
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Moving from the Letter to the Intent
Culture Change from “Me to We” Shared Quality Goals Ownership and Support
Senior ManagementCross-FunctionalLocal
Available Resources Effective Training Realistic Development Cycles Procedures are Living and Progress Focused
Software Engineering Applications Solutions, Inc. 1997. All Rights Reserved
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Thoughts or Questions?