AT3 Session 6/6/2013 10:15 AM "Agile Development in a Regulated Environment" Presented by: Chris Ampenberger PHT Corporation Brought to you by: 340 Corporate Way, Suite 300, Orange Park, FL 32073 888‐268‐8770 ∙ 904‐278‐0524 ∙ [email protected]∙ www.sqe.com
There is no doubt that agile is an accepted development methodology. However, if you work in a regulated industry like health care where you have to comply with its standard operating procedures, heaps of paperwork, and frequent audits, don’t these conflict with agile’s core tenets? Chris Ampenberger describes his operating environment and the applicable regulations that define the constraints for the software development process he can use. He shares how they overcame the incongruity between agile and regulatory requirements. With real-world examples, Chris demonstrates how you can produce the required documentation as a byproduct of the scrum team’s everyday work and illustrates how his teams succeeded in an agile way, achieving significant increases in productivity. Chris points out common pitfalls, details the hurdles they had to overcome, and discusses how to obtain buy-in from stakeholders at all levels of the organization. If you are working in a regulated environment, this session is for you.
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Transcript
AT3 Session 6/6/2013 10:15 AM
"Agile Development in a Regulated Environment"
Presented by:
Chris Ampenberger PHT Corporation
Brought to you by:
340 Corporate Way, Suite 300, Orange Park, FL 32073 888‐268‐8770 ∙ 904‐278‐0524 ∙ [email protected] ∙ www.sqe.com
Chris Ampenberger PHT Corporation
Chris Ampenberger is a development manager at PHT Corporation, the leading provider of innovative systems used to collect patient-driven eData for clinical research. Chris manages three agile development teams which maintain PHT’s back-end systems that receive and process all acquired data. He has several years of experience managing software development teams in a number of industries. Chris started practicing agile seven years ago and managed its complete implementations in two companies. He has brought PHT’s Scrum implementation to a new level by: shortening sprints; measuring team and stakeholder satisfaction; and focusing on automating unit tests, functional testing, and release documentation.
Agile Development in a Regulated EnvironmentChris Ampenberger,
Directory Engineer, PHT
Trust your Patient-Driven eData with PHT
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June 2013
Discussion Topics
1 Background
22 Say what you do and do as you say!
3 Audit Readiness is a Deliverable
4 Practice, practice, practice
22
5 Contact Info
Background
• About Me
― Chris Ampenberger
― ~27 years in IT
― Working with Agile/Scrum since 2006
― Since 2011 with PHT Corporation
• About PHT
― Develops trials to capture patient reported outcomes (ePRO) through mobile devices
― Class 1 medical device manufacturer
― Over 540 trials in 14 therapeutic areas
3
p
― >70,000 mobile devices
― Fulfillment in 68 countries, supporting 97 languages
Say what you do and do as you say!
44
US Regulations & Guidance
• 21CFR Part11 Electronic Records and Electronic Signatures Rule (Mar 1997)
• FDA Guidance for Industry: General Principles of Software Validation (Jan 2002)2002)
• FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations (May 2007)
• FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (Dec 2009)
• FDA Guidance for Industry: Electronic Source Documentation in Clinical Investigations (Dec 2010)
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Investigations (Dec 2010)
• 21CFR880 Medical Devices; Medical Device Data Systems (Feb 2011)
• FDA Guidance for Industry: Mobile Medical Applications (DRAFT Jul 2011)
European Regulations & Guidance
• DIRECTIVE 1999/93/EC … on a Community framework for electronic signatures (Dec 1999)
• Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (Feb 2011)
• Annex 11: Computerized Systems (June 2011)
• Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials (DRAFT Aug 2011
6
Regulatory Environment
• General distrust of electronic systems
• Regulators lag far behind technology
• US: Field inspectors are not always familiar with software• US: Field inspectors are not always familiar with software
• EU: EC’s and GCP Inspectors may include one or more software experts on the team
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Consequences:
Plan
Our processes and standard operating procedures used to look like the following:
Plan
Execute
D li
=
88
Deliver
Process Evolution
ExecuteDeliver
Now they look more like the following:
Plan
AnalyzeAdjust
― Documented in a framework of policies, standard operating procedures work instructions etc