Trade Agreement: CETA / WTO-AGP / NAFTA / CFTA / FTAs with Peru / Colombia / Panama / Korea
Tendering Procedures: Generally only one firm has been invited to bid
Non-Competitive Procurement Strategy: Government Objectives Representing Best Interests/Value to Govt
Comprehensive Land Claim Agreement: No
Vendor Name and Address:
1990760 ALBERTA INC.
24 Rossmere Ave SE
Medicine Hat Alberta
Canada
T1B2P5
Nature of Requirements:
TITLE: Development and Provision of Data Analysis Tools, Acquisition Processes and Validation Routines for Good Laboratory Practice (GLP) Systems and Provision of GLP Engineering Support
1. Advance Contract Award Notice (ACAN)
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. Security:
2.1 The following security requirements apply and form part of the Contract.
SECURITY REQUIREMENT FOR CANADIAN SUPPLIER:
PWGSC FILE # W7714-196744
2.1.1 The Contractor/Offeror must, at all times during the performance of the Contract/Standing Offer, hold a valid Designated Organization Screening (DOS), issued by the Canadian Industrial Security Directorate (CISD), Public Works and Government Services Canada (PWGSC).
2.1.2 The Contractor/Offeror personnel requiring access to sensitive work site(s) must EACH hold a valid RELIABILITY STATUS, granted or approved by CISD/PWGSC.
2.1.3 Subcontracts which contain security requirements are NOT to be awarded without the prior written permission of CISD/PWGSC.
2.1.4 The Contractor/Offeror must comply with the provisions of the:
a) Security Requirements Check List and security guide (if applicable), attached at Annex "C";
b) Industrial Security Manual (Latest Edition).
3. Requirement:
The Defence Research & Development Canada - Suffield Research Centre, Ralston, AB has a requirement for engineering support services.
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 CFR Part 11 for electronic data.
Standard Operating Procedures (SOPs) have been put in place at Defence Research and Development Canada (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 maintenance 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 and now must be maintained and evolve into the next iteration of data analysis tools.
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. The system has started to spread to other parts of the Section that have significant technical complexities. Further work is required if these facilities are to be made GLP compliant (e.g. Surgical Suite, Behavioural Laboratory). Continued engineering support is required for these areas.
Due to the nature of this work it is expected that there may be follow-on contracts.
4. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)
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.
5. Applicability of the trade agreement(s) to the procurement
This procurement is subject to the following trade agreement(s): Agreement on Internal Trade (AIT), World Trade Organization - Agreement on Government Procurement (WTO-AGP). North American Free Trade Agreement (NAFTA) and Canada-European Union Comprehensive Economic and Trade Agreement (CETA).
6. Justification for the Pre-Identified Supplier
This is a direct continuation of a previous contracts, W7702-09P382/001/EDM awarded through a competitive process, and W7702-125508/001/EDM and W7702-165800/001/EDM that were sole sourced using an Advanced Contract award notice.
The proposed contract is a direct continuation of a previous contracts, W7702-09P382/001/EDM awarded through a competitive process, and W7702-125508/001/EDM and W7702-165800/001/EDM that were issued on a sole source basis using an Advanced Contract award notice. 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 Organisation for Economic Cooperation and Development (OECD) Principles of GLP. It is not feasible nor affordable to compete this requirement as the complexity of the GLP System and processes would require, at a minimum, 12 months of full-time work for another Contractor to understand the GLP System, and the complexities of the data analysis validations to be able to provide the required support. 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 contractor.
Several of the key GLP systems, including electronic data integrity programming and validation systems were created by the contractor which meet RQAP-GLP standards and have been accredited by the Standards Council of Canada (SCC), the use of a new contractor will result in a minimum of 12 month delay with no guarantee of required SCC accreditation of these systems. Consequently the DRDC GLP program may fail to be accredited if these systems are now changed.
7. Government Contracts Regulations Exception(s)
The following exception(s) to the Government Contracts Regulations is (are) invoked for this procurement under subsection 6(d) - only one person is capable of performing the work.
8. Exclusions and/or Limited Tendering Reasons
The following exclusion(s) and/or limited tendering reasons are invoked under the: Agreement on Internal Trade (AIT) - Article 506, paragraph 12 (b); North American Free Trade Agreement (NAFTA) - Limited Tendering - Article 1016, paragraph (b); World Trade Organization - Agreement on Government Procurement (WTO-AGP) - Article XV, paragraph (b) and Canada-European Union Comprehensive Economic and Trade Agreement (CETA) - Article 19.12, paragraph (b.)
9. Ownership of Intellectual Property
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 as per DRDC ADM (S&T) IP-02.
10. Period of the proposed contract or delivery date
The contract will be effective from date of contract award to 2021-03-31 with the irrevocable option to extend the term of the Contract by up to THREE (3) additional one (1) year periods.
11. Name and Address of the Pre-Identified Supplier:
1990760 Alberta Inc. o/a Hyland Quality Systems
24 Rossmere Ave SE
Medicine Hat, Alberta
CANADA, T1A 4S4
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 advertised requirements.
13. Closing date for a submission of a statement of capabilities
The closing date and time for accepting statements of capabilities is indicated above.
14. Inquiries and submission of statements of capabilities
Inquiries and statements of capabilities are to be directed to:
Contracting Authority
Lorraine Jenkinson
Procurement Specialist
Procurement Branch, Western Region
Public Services and Procurement Canada
ATB Place, North Tower, 5th Floor
10025 Jasper Avenue NW
Edmonton, AB T5J 1S6
Telephone: 587-337-2458
Facsimile: 780-497-3510
Email: l••••••••@••••••••.••.ca
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 procurement.
Documents may be submitted in either official language of Canada.
