Good Laboratory Practice (GLP) System Support and Maintenance

Trade Agreement: WTO-AGP/NAFTA/AIT/Canada FTAs with Peru/Colombia/Panama 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: Brendan Hyland 204 11th Street SW Medicine Hat Alberta Canada T1A4S4 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: PSPC FILE # W7702-165800

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 Services and Procurement Canada (PSPC).

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/PSPC.

2.1.3 Subcontracts which contain security requirements are NOT to be awarded without the prior written permission of CISD/PSPC.

2.1. 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.

This is a direct continuation of a previous contract (W7702-125508/001/EDM) that was sole sourced. The contract has four primary areas where services are required:

A. Acquisition documentation and procedures for Good Laboratory Practice (GLP) systems; B. GLP data analysis tools and procedures; C. GLP electronic laboratory notebook system; and D. GLP Standard Operating Procedures (SOP) maintenance.

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 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 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) (insert the applicable trade agreement(s)): Agreement on Internal Trade (AIT), World Trade Organization - Agreement on Government Procurement (WTO-AGP). North American Free Trade Agreement (NAFTA).

6. Justification for the Pre-Identified Supplier

The proposed contract is a direct continuation of a previous sole source contract (Contract Number: W7702-125508/001/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 contractor.

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); et World Trade Organization - Agreement on Government Procurement (WTO-AGP) - Article XV, 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

It is anticipated that any contract will be effective from date of contract award to 2018-03-31.

11. Name and Address of the Pre-Identified Supplier

Brendan Hyland o/a Hyland Quality Systems 204 11th Street SW Medicine Hat, Alberta 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 are to be directed to

Contracting Authority Lorraine Jenkinson Procurement Specialist Procurement and Compensation Branch, Western Region Public Works and Government Services Canada ATB Place, North Tower, 5th Floor 10025 Jasper Avenue NW Edmonton, AB T5J 1S6

Telephone: (780) 497-3593 Facsimile: (780) 497-3510 E-mail address: Lorraine.Jenkinson@pwgsc-tpsgc.gc.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.