Quality Control Laboratory Equipment and Associated Computer Systems
Order ID |
53563633773 |
Type |
Essay |
Writer Level |
Masters |
Style |
APA |
Sources/References |
4 |
Perfect Number of Pages to Order |
5-10 Pages |
Description/Paper Instructions
Quality Control Laboratory Equipment and Associated Computer Systems
|
Proposal for QC Laboratory
Validation Services
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Date: January 23, 2012
To:
Subject: Lonza Hopkinton QC Laboratory Equipment Validation Remediation Proposal
Dear Adam,
Valspec, a partner of New England Controls (NEC), is pleased to present this proposal to partner with your team to continue the ongoing effort of providing validation document development and execution services for the Quality Control Laboratory equipment and associated computer systems at Lonza’s Hopkinton facility.
Valspec will provide a qualified resource to perform full retrospective validation of QC Laboratory equipment and associated computer systems following Lonza Life Cycle approach in order to bring the Lonza Hopkinton site into compliance with the guiding Lonza procedures.
Valspec intends to leverage its knowledge and experience of both the Portsmouth QC Lab and associated procedures along with its experience at the Lonza Hopkinton in order to deliver the most efficient effort possible. We appreciate the opportunity to support the Lonza team.
Scope Description
The scope being proposed is to develop the system lifecycle documentation for instruments and associated computer systems identified by Lonza. The subsequent qualification tasks will be preformed to achieve a validated state of the equipment in accordance with Lonza procedures and compliance best practices.
At the direction of Lonza the Valspec resource will perform the required development and or execution tasks. Below is the list of possible activities, but not limited to, that may be performed for a piece of laboratory equipment for this scope:
- Develop procedure for system date archiving and date retrieval on a Legacy system.
- Develop full User Requirement Specification (URS) and Design Qualification (DQ) for the system.
- Develop and Execute Validation Protocol test plans for the system, which includes IQ/OQ Protocol and Final Reports
- Develop a Trace Matrix
Equipment List
Valspec will complete the ongoing validation activities based on the hours estimate below on the following list of equipment:
- cIEF
- FTIR
- SpectraMax M2
- Raman
- FreezerWorks
- Additional duplicate equipment if time permits: WinKQCL, Threshold, Densitometer, TOCs
Project Labor Estimates
Valspec will provide a qualified validation resource for the development and execution of the identified deliverables based on the direction of Lonza QC management.
Project Execution
Lonza will define the specific laboratory equipment and associated computer system that need the activities describe in the scope above. Lonza will define the requirements and procedures for the gap assessment, development and execution of qualification task. Valspec will become an extension of the customer organization. Procedures for the execution of qualification activities will be reviewed and adhered to. Key to the success of this project is Valspec’s commitment to leverage Lonza’s existing investment in existing documentation and for all relevant templates and procedures.
The Valspec resource is trained on applicable Lonza operating and safety procedures and will execute the project in accordance with those procedures. Additionally, Valspec project personnel abide by our Quality Management System in the delivery of this project for both internal control and to subsidize areas not covered by client procedures. The combination of these systems will ensure the delivery of quality services in a tightly controlled methodology.
Resource Team
Valspec plans to provide a one person technical team to deliver the work scope described herein. One resource will be a site-based resource at Lonza Hopkinton and is presented at an all-inclusive hourly rate. In addition, if additional resources are required with specific expertise or to meet peak schedule demands, Valspec will apply those resources as required.
The resources will be managed by an oversight Project Manager (PM) in order to meet deadlines and schedules agreed to between Lonza and Valspec. Lonza will manage the timing of resource allocation based upon variables such as system availability and protocol approval cycles and protocol readiness.
Resource |
Title |
Labor Rate/hour |
All-inclusive rate* (Y/N) |
Miraz Chowdhury |
Senior Validation Scientist |
|
Y |
Chris Romich |
Project Manager |
|
N |
* All inclusive rate indicates a site-based resource with no additional travel and living
expenses applicable
Chris Romich is proposed as the Project Manager. Chris will serve the project in a part time role to provide commercial and communication project support and facilitation and will act as Lonza’s primary contact for project management concerns.
Project Labor Pricing Estimate
The services for the above scope are proposed on a Time and Expense (T&E) basis. An estimated labor rate, not including project management, of $119/hr is based on a Senior Validation Scientist. The period of performance for the scope as outlined in this proposal is planned as a continuous effort from on or around October 24th to January 31st, 2012.
Scope |
Hours Estimate |
Average Rate |
Total |
Full System Lifecycle Development and Execution Support |
170 |
|
|
Project Management |
8 |
|
|
TOTAL LABOR |
178 |
|
|
The total estimate price inclusive of labor, travel and living is; $21,254.00
Project Assumptions
The following assumptions apply to the services proposed herein:
- Valspec will use associated Lonza Hopkinton and Portsmouth lifecycle documents when leveraged / re-useable.
- Lonza standard document templates are assumed as the starting point for a deliverables.
- A system expert will be available to help in providing information for URS development and operation of the instruments.
- System manuals will be available and onsite for all instruments.
- The estimates in this proposal plan for one review cycle (review and comment of revision A) and one approval cycle (review incorporated comments from Revision A into Revision 0) for each deliverable document.
- The above estimates are based on standard uses of all equipment, systems and associated software.
Commercial Terms
The following commercial terms apply for this effort:
- Any applicable travel and living expenses will be billed at cost.
- Services exceeding 8 hours per day will be billed at standard hourly rates
- Rates are valid for 60 days from date of proposal
- All efforts associated with the above proposal will be provided on a T&E basis.
- Invoices will be issued monthly and will be inclusive of all hours worked and any associated travel and living expenses
- Valspec’s scope of supply is limited to those deliverables and services specifically identified in this proposal. Additional efforts can be quoted as identified.
- The services outlined above are being offered under Lonza’s standard terms and conditions
Thank you for your consideration on this quotation. Please do not hesitate to contact me with any questions at 610.495.2980.
Please send resulting purchase order via fax or to the following address:
VALSPEC, Inc.
Sincerely,
Chris Romich
VALSPEC Account Manager
Cc: VALSPEC – Ruggiero, Braun
VALSPEC 103 Enterprise Drive, Royersford, PA 610-495-0315 office, 610-495-3289 fax
RUBRIC
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