GLP Support/Maintenance

Solicitation number W7702-125508/A

Publication date

Closing date and time 2012/04/05 16:00 EDT

    Trade Agreement: NONE
    Tendering Procedures: Generally only one firm has been invited
    to bid
    Attachment: None
    Non-Competitive Procurement Strategy: Government Objectives
    Representing Best Interests/Value to Govt
    Comprehensive Land Claim Agreement: No
    Vendor Name and Address: 
    Brendan Hyland
    204 11th Street SW
    Medicine Hat Alberta
    Nature of Requirements: 
    Title:	Development of Data Analysis Tools, Acquisition Processes
    and Validation Routines for Good Laboratory Practice Systems and
    Provision of GLP Engineering Support
    1. Advance Contract Award Notice
    An ACAN is a public notice indicating to the supplier community
    that a department or agency intends to award a contract for
    goods, services or construction to a pre-identified supplier,
    thereby allowing other suppliers to signal their interest in
    bidding, by submitting a statement of capabilities. If no
    supplier submits a statement of capabilities that meets the
    requirements set out in the ACAN, on or before the closing date
    stated in the ACAN, the contracting officer may then proceed
    with the award to the pre-identified supplier.
    2. Definition of Requirement
    The Department of National Defence, Defence Research
    Establishment Suffield, Ralston, AB has a requirement for
    engineering support. 
    The Principles of Good Laboratory Practice (GLP) as governed by
    the Organization for Economic Co-operation and Development
    (OECD) and the United States Food and Drug Administration (FDA)
    specify that maintaining the integrity of raw data is a critical
    component to compliance with GLP. Both OECD and FDA provide
    guidance on the validation, maintenance and use of computerized
    systems, laboratory equipment and data analysis tools used in
    GLP studies. In the case of FDA GLP studies, this includes the
    requirements of 21  Code of Federal Regulations (CFR) Part 11
    for electronic data.
    Standard Operating Procedures (SOPs) have been put in place at
    DRDC Suffield to address procedures around setting design
    requirements for, acquiring, setting up and validating GLP
    computer systems, and data analysis tools. These SOPs must meet
    the evolving requirements of the GLPs for modern laboratory
    environments such as auditing e-data and meeting 21 CFR Part 11
    requirements in the networked environment. In addition to these
    general procedures, detailed procedures and validation routines
    for some specific systems must also be established, including a
    protected GLP data network, e-data handling and backup, and the
    upcoming implementation of the eNovator LIMS system for GLP data
    and systems.
    In addition to the hardware used in the GLP environment, the
    data analysis tools used in GLP studies must be developed,
    validated and maintained in a complex software lifecycle
    approach. The procedures for this development and validation
    lifecycle in the DRDC Suffield GLP environment have been
    established during the first GLP study, and now must be applied
    to data analysis tools being developed during the implementation
    phases for upcoming GLP studies.
    The GLP system at DRDC Suffield has been implemented through the
    development of a SOP system that describes all facets required
    for GLP and ongoing maintenance of the system is required. In
    addition, the system will be spread to other parts of the
    Section that have significant technical complexities that must
    be addressed if these facilities are to be made GLP compliant
    (e.g. Surgical Suite, Behavioural Laboratory). Engineering
    support is required for these areas.
    Due to the nature of this work it is expected that there will be
    follow-on contracts.
    3. Criteria for assessment of the Statement of Capabilities
    Any interested supplier must demonstrate by way of a statement
    of capabilities that it meets the following requirements:
    a) Education:  Masters of Science or Engineering
    b) Experience:  Implementation of Organization for Economic
    Co-operation and Development (OECD) & Food and Drug
    Administration Good Laboratory Practice (FDA GLP) compliant
    programs; Writing of SOPs, methodology and user manuals; Project
    management; Computer programming; GLP validation of computerised
    systems and data systems.
    c) The contractor must at all times during the performance of
    the Contract, hold a valid Designated Organization
    Screening(DOS), issued by the Canadian Industrial Security
    Directorate (CISD), Public Works and Government Services Canada
    4. Applicability of Trade Agreements
    This procurement is subject to the following trade agreements:
    Agreement on Internal Trade (AIT), 
    World Trade Organization - Agreement on Government Procurement,
    (WTO-AGP) North American Free Trade Agreement (NAFTA)
    5.  Justification for Pre-Identified Supplier
    The proposed contract is a direct continuation of the previously
    competitively tendered  requirement.  (Contract Number:
    W7702-09P382/001/EDM).  There was no approved strategy so DRDC
    Suffield implemented Good Laboratory Practice (GLP) from 2005 to
    2007 and a contractor is required for the ongoing maintenance of
    the GLP System, whether a study is being run or between studies.
    The personnel that maintain this capability must be fully
    conversant in the Principles of GLP.  The complexity of the GLP
    System and the processes in place to: maintain and validate GLP
    equipment systems; put in place and maintain GLP data analysis
    tools and procedures; sustain the GLP System using an electronic
    notebook system; and keep the GLP Standard Operating Procedure
    (SOP) system compliant would require, at minimum, twelve months
    of full time workup for another professional coming in at ground
    zero.  This would be required to understand the GLP System put
    in place at DRDC Suffield and understand the complexities of the
    data analysis validations required, furthermore this would push
    GLP Studies back by the period spent learning by a new
    6.  Government Contracts Regulations Exception
    The following exception to the Government Contracts Regulations
    is invoked for this procurement under subsection 6(d) - "only
    one person is capable of performing the work".
    7  Exclusions and/or Limited Tendering Reasons
    The following exclusions and/or limited tendering reasons are
    invoked under the section of the trade agreement specified:
    Agreement on Internal Trade (AIT) - Limited Tendering under
    Article 506, #12 b
    North Ameriican Free Trade Agreement (NAFTA) - Limited Tendering
    - Article 1016: b.
    WTO-AGP not applicable, as per Services in Appendix I, Canada -
    Annex 4.
    8.  Ownership of Intellectual Property
    Defence Research and Development Canada (DRDC) has determined
    that any intellectual property arising from the performance of
    the Work under the Contract will vest in Canada. DRDC is
    exempted from the Treasury Board "Policy on Title to
    Intellectual Property Arising Under Crown Procurement Contracts"
    approved 1 June 2000.
    9.  The Period of the Proposed Contract
    The proposed contract is for a period of approximately 2 years,
    from May 1, 2012 to March 31, 2014, with an option to extend for
    an additional two, one year periods ending on March 31, 2016.
    10.  The Estimated Cost of the Proposed Contract
    The estimated value of the contract, including options is
    $470,000.00, GST extra for the 4 year period.
    11.  Name and Address of the Pre-Identified Supplier:
    Brendan Hyland Quality Systems
    221 - 5th Street SE
    Medicine Hat, AB    T1A 0M5
    12.  Suppliers' Right to Submit a Statement of Capabilities
    Suppliers who consider themselves fully qualified and available
    to provide the goods, services or construction services
    described in the ACAN, may submit a statement of capabilities in
    writing to the contact person identified in this notice on or
    before the closing date of this notice. The statement of
    capabilities must clearly demonstrate how the supplier meets the
    13.  The Closing Date and Time for Accepting Statements of
    April 5, 2:00 pm (MDST)
    14.  Inquiries and Submission of Statement of Capabilities
    Inquiries and statements of capabilities are to be directed to:
    Elaine Barton, Supply Specialist
    Public Works and Government Services Canada
    Telus Plaza North
    5th Floor 10025 Jasper Avenue
    Edmonton, AB   T1J 1S5
    Facsimile: 780-497-3510
    Delivery Date: Above-mentioned
    You are hereby notified that the government intends to negotiate
    with one firm only as identified above. Should you have any
    questions concerning this requirement, contact the contracting
    officer identified above.
    An Advance Contract Award Notice (ACAN) allows departments and
    agencies to post a notice, for no less than fifteen (15)
    calendar days, indicating to the supplier community that it
    intends to award a good, service or construction contract to a
    pre-identified contractor. If no other supplier submits, on or
    before the closing date, a Statement of Capabilities that meets
    the requirements set out in the ACAN, the contracting authority
    may then proceed with the award.  However, should a Statement of
    Capabilities be found to meet the requirements set out in the
    ACAN, then the contracting authority will proceed to a full
    tendering process.
    Suppliers who consider themselves fully qualified and available
    to provide the services/goods described herein, may submit a
    statement of capabilities in writing to the contact person
    identified in this Notice on or before the closing date of this
    Notice. The statement of capabilities must clearly demonstrate
    how the supplier meets the advertised requirements.
    The PWGSC file number, the contracting officer's name and the
    closing date of the ACAN must appear on the outside of the
    envelope in block letters or, in the case of a facsimile
    transmission, on the covering page.
    The Crown retains the right to negotiate with suppliers on any
    Documents may be submitted in either official language of Canada.

    Contract duration

    Refer to the description above for full details.

    Trade agreements

    • No trade agreements are applicable to this solicitation process

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    Contact information

    Contracting organization

    Public Works and Government Services Canada
    11 Laurier St, Phase III, Place du Portage
    Gatineau, Quebec, K1A 0S5
    Contracting authority
    Barton, Elaine
    (780) 497-3519 ( )
    (780) 497-3510
    Telus Plaza North/Plaza Telus Nord
    10025 Jasper Ave./10025 ave Jasper
    5th floor/5e étage
    Edmonton, Alberta, T5J 1S6

    Buying organization(s)

    Department of National Defence
    101 Colonel By Dr
    Ottawa, Ontario, K1A0K2
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    Summary information

    Notice type
    Advance Contract Award Notice
    English, French
    Region(s) of delivery
    Commodity - GSIN
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