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.
9/8/2019
1
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 1@kauffmj #STARCANADA2019
Agility. Security. Delivered.
Document Generationfor Regulated Industries
Jonathan Miller Kauffman
@kauffmj
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 2@kauffmj #STARCANADA2019
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
1
2
9/8/2019
2
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 3@kauffmj #STARCANADA2019
Client
Class II
Produces medical devices that are heavily regulated and sold internationally.
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 4@kauffmj #STARCANADA2019
Agile Assessment
3
4
9/8/2019
3
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 5@kauffmj #STARCANADA2019
Problem
Extensive regulatory documentation requirements delayed new releases.
Initial State
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 6@kauffmj #STARCANADA2019
Problem
Allocating sprint time to documentation was an improvement, but still not ideal.
Incremental Improvement
5
6
9/8/2019
4
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 7@kauffmj #STARCANADA2019
Solution
Overview
Document Generator
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 8@kauffmj #STARCANADA2019
Solution
Generated Document Format – High-Level View
7
8
9/8/2019
5
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 9@kauffmj #STARCANADA2019
Solution
Generated Document Format – Header and Footer Sections
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 10@kauffmj #STARCANADA2019
Solution
Generated Document Format – Signature Table
9
10
9/8/2019
6
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 11@kauffmj #STARCANADA2019
Solution
Generated Document Format – Revision History and Table of Contents
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 12@kauffmj #STARCANADA2019
Solution
Generated Document Format – Version History Log Table (Core Section)
11
12
9/8/2019
7
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 13@kauffmj #STARCANADA2019
Solution
Generated Document Format – Version History Log Table (Core Section)
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 14@kauffmj #STARCANADA2019
Solution
JIRA as the Source of Truth
Build Type Build Number
implies
13
14
9/8/2019
8
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 15@kauffmj #STARCANADA2019
Solution
Document Generation Capability
Document Generator
TEMPLATE BASE
DRAFT
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 16@kauffmj #STARCANADA2019
Solution
User Interface
Document Generator
Document Storage
Document Creation
15
16
9/8/2019
9
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 17@kauffmj #STARCANADA2019
Solution
Benefits
Days Minutes
TEMPLATE
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 18@kauffmj #STARCANADA2019
Solution
Drawbacks
1
2
17
18
9/8/2019
10
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 19@kauffmj #STARCANADA2019
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.
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 20@kauffmj #STARCANADA2019
#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.
19
20
9/8/2019
11
© COPYRIGHT 2019 COVEROS, INC. ALL RIGHTS RESERVED. 21@kauffmj #STARCANADA2019
‘@JMK’ on the HUB
http://hub.techwell.com
Questions?
21