Data Integrity – Beyond “Good Documentation Practices” A small company view to creating a culture of compliance-2017-08-23

Event Information
Event Name: 
Data Integrity – Beyond “Good Documentation Practices” A small company view to creating a culture of compliance
Event Date: 
08/23/2017 - 7:00pm
Event Location: 
Stellartech in Milpitas, CA
Event Details
Event Type: 
Event Details: 

August Roundtable - Wed 23rd Data Integrity – Beyond “Good Documentation Practices” A small company view to creating a culture of compliance


George J. Marcel
Director of Quality Assurance at TheraNova LLC

Wednesday, August 23, 2017, 7:00 to 9:00 pm at Stellartech in Milpitas, CA

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21CFR11.3(b5) requires that "the integrity of the data can be verified".

21CFR820 has 10 references to ”data”

21CFR820.180 requires data "made readily available…legible...stored to minimize deterioration and loss…backed up”.

ISO 13485(2016) has new requirements for “data analysis”, to “protect” “confidential…information”

Data, whether captured in paper or electronic format, is the basis for product assumptions and decisions from the manufacturing floor to the boardroom to the offices of regulators and notified bodies. Medical Device companies, especially small start-ups, often limit discussions of data integrity to “Good Documentation Practices”. GDP is a set of widely accepted, unwritten rules, dealing with the collection of data during design and manufacture of a product, mostly focused on paper based systems, where “data integrity” refers to the completeness, consistency, and accuracy of all data. Validations of electronic systems that collect and store data and management of paper-based systems can be daunting to resource-constrained companies. Before the protocols, quality professionals should start with a “culture of compliance” based on ensuring a common understanding of the significance of managing and maintaining product and design data at all stages of the product lifecycle.

Featured Speaker:

Brian McCollum, Vice President, Quality, Apama Medical, BS Aerospace Engineering, MBA, CQA, CQE. Brian has over 20 years experience in Medical Device Quality Management ranging from large multinational commercial organizations to small pre-clinical start-ups. Brian was one of the long-term members of the Northern California Biomedical Discussion Group in the years 1998-2010, and served in various roles, including Communications, and Arrangements.

Payment Dec 12th Evening Event - $20 to TheGeneral Public

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