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Implementing a Calibration Management System
Cory OttoPrincipal Metrology Engineer, Boston Scientific
10 October 2012
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Agenda
Discuss establishing the need for a new calibration management system
Review selection process Provide high level overview of implementation activities Discuss lessons learned Answer questions
2
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Establishing Need
3
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Establishing Need
FDA Corporate Warning Letter Legacy Software Remediation (LSR) efforts
Calibration management system (CMS) determined to be in scope Had not been previously validated
CMS was assessed Issues noted
-Security
-Operations and maintenance
-Producibility
-Audit trails
-Electronic records/electronic signatures
4
In the end, it was determined that it would be non-value added to bring
CMS to a substantially validated state
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Selection Process
5
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Selection Process
Reviewed CMS options Established initial requirements Weighted options vs. initial requirements
6
Option 1 Option 2 Option 3 Old CMS
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Selection Process
Meeting #1 with senior management (January 2009) – Explained need– Reviewed alternatives– Proposed Option 1– Response:
• Investigate feasibility
of Option 3
7
Option 1 Option 2 Option 3 Old CMS
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Lessons Learned
Beware the
8
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Selection Process
Meeting #2 with senior management (April 2009)– Explained why Option 3 would not meet requirements– Proposed Option 1
• Explained how it meets requirements and has exciting Metrology bells and whistles
– Senior management response:• What are the other sites using?
9
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Lessons Learned
Be prepared! Know what is important to your audience
10
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Selection Process
Meeting #3 with senior management (June 2009)– Explained what each site was using as a CMS
• Many sites were using CalMan v4.x (the predecessor to BMRAM)– Proposed Option 2 (BMRAM)
• Explained how it meets requirements – Senior management response:
• Nothing!
11
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Lessons Learned
You need an advocate
12
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Selection Process
Meeting #4 with senior management (August 2009)– Explained need– Reviewed site CMS usage– Discussed financial information– Proposed BMRAM
• Explained how it meets requirements – Requested approval– Senior management response:
• Nothing!
13
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Lessons Learned
Have patience
14
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Selection Process
November 2009– Received senior management permission to move forward with
the purchase and implementation of BMRAM– Added to Corporate Information Systems meeting agenda to
request IS Project Manager
December 2009– Corporate Information Systems meeting delayed multiple times– Maple Grove Metrology management decision made to move
forward without IS Project Manager
15
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Implementation
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Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 17
Establish a TeamCore team
Project lead Metrology management Metrology Engineer Technical Writer Software Quality Engineer Blue Mountain Project Manager
Extended team members Previous CMS Administrators Customers
Focus panel from other BSC sites
Focus Panel
Extended Team Members
Blue Mountain Validation Rep
Maple Grove: Metrology (x2)
&SQA
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Lessons Learned
If time allows, have a representative from each role on your core team
18
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 19
Develop a PlanDeveloped Microsoft Project plan
Feeders Blue Mountain’s input/internal project management process Boston Scientific’s validation requirements Personnel schedules Deliverables LSR timeline
Vetting process Reviewed by
Metrology management Software Quality management Senior management Corporate IS management
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Lessons Learned
Plan the work and work the plan
20
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 21
Learn the LanguageUnderwent validation training
Majority of core team had never validated software before Wanted to select a validation method that would allow other Boston
Scientific sites the opportunity to leverage validation in the future Needed to understand deliverables
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 22
Validation DeliverablesConcept document
–Why are you validating this software?Project assessment
–Series of generic questions – Intended use based rating system to determine the level of
validation requiredHazards and risk analysis
–Early understanding of potential hurdles on the horizon
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 23
Validation DeliverablesRequirements
–What do you require of the software?–Feeders
• End users• Department workflows• Software Quality requirements• FDA/CFR requirements
Testing scripts–Plans–Scripts
• Installation qualifications (hardware and software)• Operational qualifications• Performance qualifications
–ReportsDesign
–Hardware and software
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 24
Validation Deliverables Implementation planBusiness continuity planProduction support plan
In total, there were 50 documents created or updated as part of this project
(totaling 79 revisions)
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Jan-Identified project team (Team Pinnacle)-Developed Project Plan
May-Developed Test Plan-Migrated Data (1 of 3)
June -Conducted IOQ testing
July -Documented testing-Developed validation documents
Dec -Go live!
Feb-Developed BPR-Developed and purchased hardware architecture
Mar-Documented requirements specification-Qualified hardware
Apr-Completed GSM Planning phase-Conducted site assessment-Configured software
Aug -Conducted PQ testing-Migrated data (2 of 3)
Sep -Create WIs
Oct-Train end users-Migrate data (3 of 3)
Nov -Align system data-Complete validation docs
Validation Deliverables
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 26
Lessons LearnedKeep everyone up to date and hold everyone accountable
Core team met weekly Reviewed
Closed action items Open action items Current status Path forward plan
Corporate IS meetings were monthly to quarterly Senior management meetings were quarterly
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 27
Lessons LearnedErr on the side of over communication with your end users
Announcements Seeking input Training Refresher training
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 28
Lessons LearnedUse as much time as possible to scrub your data
What good is a shiny new toy with garbage in it?
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 29
Lessons LearnedYou need a strong partner
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally
Questions?
Cory Otto
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