OraSure simplementation of Quality Notifications in Compliance with FDA Regulations. Scott Baker, OraSure Technologies, Inc. Earl Haniford, QMS, Inc.

Transcription

1 OraSure simplementation of Quality Notifications in Compliance with FDA Regulations Scott Baker, OraSure Technologies, Inc. Earl Haniford, QMS, Inc.

2 LEARNING POINTS Review OraSure s Project Scope and Timeline Understand business objectives and resources Activating and Leveraging features of the Enhancement Packs Improvements to digital signatures and lot traceability Innovative method to creating Form Content as Master Data Combining Z tables, standard text, and common components of tasks to build and update dynamic form content

3 OraSure : Corporate Overview A leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions Products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse A leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications OraQuick HCV Oragene DNA OraSure QuickFlu 3

4 QMS : Corporate Overview QMS delivers the best management, functional, and technical professionals with the right blend of knowledge, expertise, and qualifications needed to achieve success. We are dedicated to the delivery of quality and value to our customers. Our highly skilled team, coupled with a minimized overhead structure, enables us to efficiently deliver rapid, focused and cost efficient solutions. We are focused on Manufacturing and Quality in the Life Science Industry, Medical Devices and Scientific Instruments, Biotechnology and Biopharmaceuticals and Pharmaceutical, Manufacturing, Equipment Manufacturers, Food, CPG, and Chemical Companies as well as Hi-Tech, Automotive, A&D and Utilities. We believe If you can t Measure it; you can t Manage it! 4

5 OraSure: Recent News 7/3/2012 FDA approves OraQuick, the first at-home HIV test. 5

6 BEST PRACTICES Quality Notifications - Project Scope Consumer Complaints (OTC Business) Customer Complaints (Base Business) Product, Process, or System Nonconformances Planned Deviations CAPA Corrective and Preventive Action

7 BEST PRACTICES PROJECT TIMELINE: Design to System Delivery Blueprint Prior Processes 1 week 4 weeks Development Configuration and Form Creation Test Script Creation Development Testing 2 weeks 2 Weeks Business Process Procedures Quality Testing System Validation

8 Validation Deliverables Validation Master Plan (VMP) User/Functional Requirements (URS/FRS) Installation Qualification Protocol (IQ + Report) Traceability Matrix Operational Qualification/Performance Qualification Protocol (OQ/PQ + Report) Business Process Procedures and Configuration Documents Production Installation and Performance Qualification (IQ/PQ + Report) Computer Validation Summary Report (CVSR) BEST PRACTICE

9 LEARNING POINTS Review OraSure s Project Scope and Timeline Understand business objectives and resources Activating and Leveraging features of the Enhancement Packs Improvements to digital signatures and lot traceability Innovative method to creating Form Content as Master Data Combining Z tables, standard text, and common components of tasks to build and update dynamic form content

10 BEST PRACTICES Enhancement Pack 3 Requirement Digital Signatures at both the Quality Notification Header and Quality Notification Task level Activating EHP3 for ECC6 Unlocks functionality for Quality Notification objects

11 BEST PRACTICES Enhancement Pack 3 Transaction SFW5 SAP s Switch Framework Prerequisites

12 BEST PRACTICES QN Types Screen areas specific to content Configurable objects Connectivity with CAPA s

13 BEST PRACTICES QN Types Reference objects Screen areas (tabs) Priorities Partners Catalogs (subject, defects, task, etc.) Action box

14 BEST PRACTICES Different info collected = different QN types Ability to link issue directly to a CAPA

15 BEST PRACTICES QN Tasks Benefits Predefined list of action items Two forms of free text input Date / Time assignments User assignment Workflow trigger upon release Digital Signature capture upon completion Contains bulk of info required in outputs Utilized for driving actions and collection of detail information

16 BEST PRACTICES 1 Task code description 2 Task code limited free text 3 Task code long text

17 BEST PRACTICES 4 Responsible party 5 Start/Finish dates 6 Task status

18 BEST PRACTICES QN Tasks - continued Defaulted upon QN creation Z* table holding: Tasks Partner type Responsible partner Maintainable through Z* transaction with appropriate authorization Provided a template of action items per QN type Task entry per approval needed

19 Digital Signature Info BEST PRACTICES

20 BEST PRACTICES QN Outputs 15 unique outputs some containing multiple pages 90% of content driven from a Z* table Reduced development time to keep project on schedule Areas of Smart Forms linked to standard text and/or components of defects, root cause and tasks Allowed for maintenance in Production without transports

21 LEARNING POINTS Review OraSure s Project Scope and Timeline Understand business objectives and resources Activating and Leveraging features of the Enhancement Packs Improvements to digital signatures and lot traceability Innovative method to creating Form Content as Master Data Combining Z tables, standard text, and common components of tasks to build and update dynamic form content

22 KEY LEARNINGS Familiarization with the solution can drive faster delivery and better design Leverage different notification types to meet your teams objectives and data collection needs Forms are incredibly important to the end user and leveraging a dynamic design will make the world a better place

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24 THANK YOU FOR PARTICIPATING Please provide feedback on this session by completing a short survey via the event mobile application. SESSION CODE: 2709 For ongoing education on this area of focus, visit