Document!Generation!for!Regulated! Industries! · W13! Compliance’ Wednesday,’October’23rd,’2019’3:00PM’ ’ ’ ’ ’ Document!Generation!for!Regulated! Industries!!

W13 Compliance Wednesday, October 23rd, 2019 3:00 PM

Document Generation for Regulated Industries

Presented by:

Jonathan Kauffman

Coveros, Inc.

Brought to you by:

888-‐-‐-‐268-‐-‐-‐8770 ·∙·∙ 904-‐-‐-‐278-‐-‐-‐0524 -‐ [email protected] -‐ http://www.starcanada.techwell.com/

Jonathan Kauffman Jonathan Kauffman works as an agile software development and test consultant at Coveros, a company that helps organizations develop secure software using agile methods. In this role, Jonathan has helped both government and commercial organizations develop and test high-‐quality applications, and he has gained his experience by working with health care, biomedical device, and research organizations. Jonathan also presents at and attends Meetups to help maintain his connection with the software testing community and to stay abreast of recent industry developments. Before joining Coveros, he earned his B.S. in computer science from Allegheny College, where he published research on techniques for optimizing regression test suites.

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© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 1@kauffmj #STARCANADA2019

Agility. Security. Delivered.

Document Generationfor Regulated Industries

Jonathan Miller Kauffman

@kauffmj


Introduction to Me

• Senior Consultant at Coveros

• 7+ years of agile development and testing experience using techniques such as TDD and BDD

• Experience working with government and commercial clients

• Experience automating testing within regulated industries

• Organizes the NOVA Software Quality Engineering and Automation Meetup

• Enjoys hiking, volunteering, Toastmasters, and playing the piano

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Client

Class II

Produces medical devices that are heavily regulated and sold internationally.


Agile Assessment

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Problem

Extensive regulatory documentation requirements delayed new releases.

Initial State


Problem

Allocating sprint time to documentation was an improvement, but still not ideal.

Incremental Improvement

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Solution

Overview

Document Generator


Solution

Generated Document Format – High-Level View

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Solution

Generated Document Format – Header and Footer Sections


Solution

Generated Document Format – Signature Table

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Solution

Generated Document Format – Revision History and Table of Contents


Solution

Generated Document Format – Version History Log Table (Core Section)

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Solution

Generated Document Format – Version History Log Table (Core Section)


Solution

JIRA as the Source of Truth

Build Type Build Number

implies

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Solution

Document Generation Capability

Document Generator

TEMPLATE BASE

DRAFT


Solution

User Interface

Document Generator

Document Storage

Document Creation

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Solution

Benefits

Days Minutes

TEMPLATE


Solution

Drawbacks

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[email protected]

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Future Work

Generating Additional Documents

BASEDocument Generator

The base document and source of truth for each new document should be chosen before modifying the document generation code and UI.


#Coveros5

1. Automate regulatory documentation generation to allow the team to focus on activities that produce value for the customer.

2. Define a single source of truth for the information used to generate documentation.

3. Define a base document with information that must be filled in by a human being.

4. Team members should be working within the source of truth instead of in the generated documentation.

5. Update legacy data such that all fields required for document generation are populated.

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[email protected]

‘@JMK’ on the HUB

http://hub.techwell.com

Questions?

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mailto:[email protected]