Implementing a Calibration Management System Cory Otto Principal Metrology Engineer, Boston Scientific 10 October 2012.

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

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Establishing Need

3


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

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In the end, it was determined that it would be non-value added to bring

CMS to a substantially validated state


Selection Process

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Selection Process

Reviewed CMS options Established initial requirements Weighted options vs. initial requirements

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Option 1 Option 2 Option 3 Old CMS


Selection Process

Meeting #1 with senior management (January 2009) – Explained need– Reviewed alternatives– Proposed Option 1– Response:

• Investigate feasibility

of Option 3

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Option 1 Option 2 Option 3 Old CMS


Lessons Learned

Beware the

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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?

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Lessons Learned

Be prepared! Know what is important to your audience

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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!

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Lessons Learned

You need an advocate

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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


Lessons Learned

Have patience

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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

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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


Lessons Learned

If time allows, have a representative from each role on your core team

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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


Lessons Learned

Plan the work and work the plan

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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


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


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


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)


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


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


Lessons LearnedErr on the side of over communication with your end users

Announcements Seeking input Training Refresher training


Lessons LearnedUse as much time as possible to scrub your data

What good is a shiny new toy with garbage in it?


Lessons LearnedYou need a strong partner


Questions?

Cory Otto

[email protected]

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Implementing a Calibration Management System Cory Otto Principal Metrology Engineer, Boston Scientific 10 October 2012.

Documents

boston scientific confidential

internal use

old cms slide

state slide

selection process meeting

feasibility of option

cms options

validated cms