Pacific Coast Information Systems

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Pacific CoastInformation Systems

• Innovative Solutions.
• Individual Service.

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• Presented by
• Paul King
• Director, Life Sciences
• 604.844.7558
• paulking_at_pcis.com
• www.pcis.com

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Using Technology to Reduce Time-to-Market and
Attract Partners

• The FDA's current approach to 21 CFR Part 11 and
  what companies need to do
• How to reduce time-to-market by implementing an
  electronic submission program
• Selecting the right technology tools for your
  biotech
• Developing an IT strategy to accurately plan for
  upcoming challenges
• How your IT strategy can attract partners and
  increase investment

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The FDA's current approach to 21 CFR Part 11 and
what companies need to do

• Conduct a Risk Assessment
• Internal - conduct inventory of all software
  systems
• External - what software do our contactors use?
• What does the company consider to be source
  documents?
• the paper or electronic version?
• does it directly affect human life?
• does it directly affect the product?
• do we make critical decisions using this
  information?

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The FDA's current approach to 21 CFR Part 11 and
what companies need to do

• Internal Risk Assessment Matrix Example
• Impact of the systemvs.
• Type of system (infrastructure, configured, off
  the shelf, built)
• Programs
• Word, Excel, Oracle
• Applications
• spreadsheets
• databases

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Risk Assessment Types of Systems

• Tier One (IT)
• Hardware, Operating Systems, Infrastructure
• Tier Two (IT, QA)
• General Purpose Off The Shelf Software Packages
  (Excel)
• Tier Three (QA, IT, Dept)
• Commercial Configurable Software Packages / Tools
• Tier Four (IT, Dept, QA)
• Custom Developed Systems and Applications
  (spreadsheets)

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Risk Assessment - Criticality of the system

• High
• Complete validation within 4 months
• Medium
• Complete validation within 12 months
• Low
• Complete validation within 24 months
• Not Applicable

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Risk Assessment Example

• High (33)
• Complete validation within 4 months
• Medium (145)
• Complete validation within 12 months
• Low (235)
• Complete validation within 24 months
• Not Applicable (20)

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Risk Assessment

• Balance between doing too much and not doing
  enough
• Assemble a team (budget commitment, staff,
  training)
• Conduct an assessment
• Document your approach
• Do what you say (or at least document the actual
  timeline)

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The FDA's current approach to 21 CFR Part 11 and
what companies need to do

• External Risk Assessment Matrix Example
• Similar approach as internal
• Our vendors are Part 11 compliant
• Does not matter if the data is down the hallway
  or down the highway
• Audit the vendor / supplier / CRO in the same way
  the FDA will audit you!

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Computer System Validation Documentation
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European Union

• Expanded requirements in some areas
• Implementation of eSignatures
• registry of qualified certificate providers
• legal equivalence of handwritten signatures in
  some E.U. countries
• Physical security considerations
• protect data from accidental or unlawful
  destruction or accidental loss, alteration,
  unauthorized disclosure or access
• Disaster recovery
• conduct and document an analysis that identifies
  the time-critical processes supported by the
  computer system, the maximum response time for
  these processes and the business plans enabling
  all required processes to be completed within
  response times
• Manual system replacement
• system should be run in parallel for one complete
  cycle
• Management of critical data
• When critical data is entered manually, there
  should be an additional check on record accuracy
• FDANews, September 2003

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How to reduce time-to-market by implementing an
electronic submission program

• By the year 2002, the FDA is mandated to
  have the ability to receive fully electronic
  submissions. This is not the date by which the
  industry must make all submissions
  electronically, nor has a date been determined
  yet. Currently, all electronic submissions are
  voluntary.
• http//www.mastercontrol.com

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Electronic Submissions The Agency

• The mandate of the Agency is for faster, more
  efficient submission reviews
• NDA Electronic Submission Training Manual
• http//www.fda.gov/cder/regulatory/ersr/nest.pdf
• "Once the drug application reviewers see what
  they can do with a good electronic submission,
  it's hard to go back to the paper. Randy
  Levin, FDA

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Electronic Submissions - Joint Benefits

• Greatly reduced physical storage requirements
• Enhanced submission quality, organization and
  completeness
• Increased accessibility through creation of a
  long-term, easily accessible archive of all
  submission documents
• More efficient review - transparency
• Centralized processing at the FDA
• Ease with which reviewers can locate and view
  referenced documents, through use of electronic
  bookmarks, hyperlinks and indexing
• No need for traditional reviewer aids because all
  electronic items are provided in
  guidance-compliant form for archiving
• Less time spent in manual processing of data

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Electronic Submissions

• Lets copy everything onto a CD!

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(The Real) Electronic Submission Process
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Are Companies Doing e-Submissions?

• 1999 - 250
• 2000 - 500
• 2001 - 1,400
• 29 paper, 35 hybrid, and 36 fully electronic
• 2002 - Agency must be able to accept and review
  e-subs
• 2003 - electronic plus a paper copy for legal
  purposes
• 75 fully electronic (Randy Levin, FDA)
• 2005? - only electronic version needed/accepted

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Developing an IT strategy to accurately plan for
upcoming challenges
Stage 5 Service Drives the Business Strategy
Stage 4 Service is Integral to the Business
Strategy
Stage 3 Service Supports the Business Strategy
Value
Stage 2 Service Supports the IT Strategy
Stage 1 Service Supports Products
Cost
Cost-Effective
ROI
ROA
Revenue Generation
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Selecting the right technology tools
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Developing an IT strategy to accurately plan for
upcoming challenges

• Data is a valuable corporate asset and should be
  managed as such, like cash, facilities or any
  other corporate asset
• Centralized steward of corporate data and is
  responsible for managing it over its life cycle -
  from its generation to its appropriate
  destruction
• Responsible for controlling access to and use of
  data, as determined by governmental regulation
  and corporate policy
• Responsible for preventing the inappropriate
  destruction of data
• Responsible for bringing technological knowledge
  to the development of data management practices
  and policies
• IT partners with executives to develop and
  execute the organization's data management
  policies
• Not responsible for maintaining the accuracy of
  data

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Selecting the right technology tools

• Trend to move away from in house developed
  applications to Commercial Off The Shelf
• Since data flows between applications there is a
  need for a strong IT Strategic Plan
• IS Steering Committee
• How will your systems communicate?
• Impact on the validated state?
• Records retention plan?
• Contact similar sized companies

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How your IT strategy can attract partners and
increase investment

• Biotech firms value-creating activities are
  based on managing Intellectual Capital
• 1 million a day opportunity cost
• 12 year development cycle
• Create an appropriate strategy for organizing,
  retaining, restoring, and utilizing electronic
  data
• Documented processes instill confidence

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Further Information

• Institute of Validation Technology
• http//www.ivthome.com/
• General information
• www.fdanews.com
• 21 CFR Part 11 Discussion June 11th,
  2004http//www.fda.gov/OHRMS/DOCKETS/98fr/04n-013
  3-nm00001-vol1.pdf

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• Thank-you!