Wed Sep 15, 2004 09:25 AM ET
WASHINGTON (Reuters) - J.P. Morgan Chase & Co. (JPM.N: Quote, Profile, Research) said on Wednesday it was canceling a $5 billion outsourcing deal with IBM Corp., (IBM.N: Quote, Profile, Research) and planned to rehire about 4,000 workers who had been transferred to IBM under the pact.
IBM said in a U.S. Securities and Exchange Commission filing that the cancellation of its biggest financial services outsourcing deal would help its 2005 earnings per share, and would have no impact on its full-year model.
J.P. Morgan, the No. 2 U.S. bank, said following its recent merger with Bank One, it could better manage its own technology and infrastructure. It also said there will be no material impact from the cancellation.
IBM said the cancellation would improve earnings because it was still in the early stages of deployment on the contract. It also said its backlog of services will be revised when it announces its third-quarter earnings. IBM estimated a $118 billion services backlog at the end of the second quarter.
Under the seven-year deal announced in December 2002, IBM was to take over the global computing operations for J.P Morgan in a wide range of areas including retail banking, trading and securities processing, offering the bank an opportunity to cut its own spending on technology.
The 4,000 workers transferred to IBM from J.P. Morgan in early 2003.
J.P. Morgan said IBM would remain one of the largest technology partners for J.P Morgan, but the companies did not elaborate on their relationship going forward. (With additional reporting by Chris Sanders)
© Reuters 2004. All Rights Reserved.
Tuesday, March 15, 2005
FDA Watch : Commissioning - A Risk-based Approach
An excerpt from Institute of Validation Technology.
The Institute of Validation Technology indicates that the Commissioning of systems and equipment within the pharmaceutical industry is quickly becoming a stable endeavor. While the intent of the practice was to cut the cost associated with validation, it has quickly become entangled in the web of Risk Assessment and Management.
Every system and piece of equipment utilized in the pharmaceutical and medical device industries is subject to a commissioning exercise. Commissioning using a risk assessment approach is best applied to new equipment and system installations.
Commissioning is now being viewed as an active part of the qualification process. It is imperative that it be performed in a structured, analytical and compliant way. Current FDA regulations do not mandate that commissioning or risk assessments be performed, but it is the trend and the latter may be the justification for the prior.
Many questions arise when one considers the application of risk assessment when conducting Commissioning. Among these are:
• When do we apply risk assessment?
• What thinking and planning are involved?
• What tools might be available to conduct this activity?
• Will the FDA care?
• What does it do for me or my project?
• How are risk assessment and commissioning related?
• What is the current thinking of the FDA regarding Commissioning and Risk Assessment?
• Where do we start with risk assessment?
• How do these concepts affect the final outcome of qualification and validation?
The Institute of Validation Technology indicates that the Commissioning of systems and equipment within the pharmaceutical industry is quickly becoming a stable endeavor. While the intent of the practice was to cut the cost associated with validation, it has quickly become entangled in the web of Risk Assessment and Management.
Every system and piece of equipment utilized in the pharmaceutical and medical device industries is subject to a commissioning exercise. Commissioning using a risk assessment approach is best applied to new equipment and system installations.
Commissioning is now being viewed as an active part of the qualification process. It is imperative that it be performed in a structured, analytical and compliant way. Current FDA regulations do not mandate that commissioning or risk assessments be performed, but it is the trend and the latter may be the justification for the prior.
Many questions arise when one considers the application of risk assessment when conducting Commissioning. Among these are:
• When do we apply risk assessment?
• What thinking and planning are involved?
• What tools might be available to conduct this activity?
• Will the FDA care?
• What does it do for me or my project?
• How are risk assessment and commissioning related?
• What is the current thinking of the FDA regarding Commissioning and Risk Assessment?
• Where do we start with risk assessment?
• How do these concepts affect the final outcome of qualification and validation?
Let’s Begin with the Basics . . .
By Mark Gunn
The inherent philosophy of Quality Assurance for software systems development projects is to ensure that the system meets or exceeds the agreed upon requirements of the end-users; thus creating a high-quality, fully functional and user-friendly application. This philosophy applies to all system development projects and includes mainframe, client server, and web based applications.
“Quality Assurance is more than just testing”
Quality Assurance is more than just testing. Quality Assurance is involved throughout a project’s lifecycle.
• The Quality Assurance effort begins with the analysis phase of the project, continues through the design and execution phases and proceeds until the application is in production and beyond.
• Introducing solid quality assurance concepts and methods into the system development life cycle early on and maintaining them throughout the Software Development Life cycle (SDLC) is the key to the overall success and total quality of the project.
Quality Assurance is a commitment to the Total Quality of the Project
• This commitment to the philosophy of Total Quality requires all team members to adhere to the guidelines and methods that will ensure the excellence of the system being developed.
This philosophy is the backbone for the Software Development Life cycle. As our IT industry matures we find that having sound development and quality assurance methodologies ensures that applications or application enhancements are delivered to our customers on time and with no production problems. When this process breaks down, and this can be for many, many reasons, we find that the product we deliver can be less than what was agreed upon.
The inherent philosophy of Quality Assurance for software systems development projects is to ensure that the system meets or exceeds the agreed upon requirements of the end-users; thus creating a high-quality, fully functional and user-friendly application. This philosophy applies to all system development projects and includes mainframe, client server, and web based applications.
Quality Assurance is more than just testing. Quality Assurance is involved throughout a project’s lifecycle.
• The Quality Assurance effort begins with the analysis phase of the project, continues through the design and execution phases and proceeds until the application is in production and beyond.
• Introducing solid quality assurance concepts and methods into the system development life cycle early on and maintaining them throughout the Software Development Life cycle (SDLC) is the key to the overall success and total quality of the project.
Quality Assurance is a commitment to the Total Quality of the Project
• This commitment to the philosophy of Total Quality requires all team members to adhere to the guidelines and methods that will ensure the excellence of the system being developed.
This philosophy is the backbone for the Software Development Life cycle. As our IT industry matures we find that having sound development and quality assurance methodologies ensures that applications or application enhancements are delivered to our customers on time and with no production problems. When this process breaks down, and this can be for many, many reasons, we find that the product we deliver can be less than what was agreed upon.
Welcome to the MGDServices Quality Assurance Newsletter
Welcome to the first issue of the MGDServices Quality Assurance Methods and Practices Newsletter. Periodically we will be providing you with industry trends, developments and news that affect Quality Assurance, FDA Validation, and our IT family of professionals.
We are confident you will find this information a valuable resource for your day to day activities.
MGDServices Has a New LocationMGDServices has relocated to a new location in Hunterdon County, NJ. Gretchen Gunn states “Our new location keeps us close to our clients while adding the additional office space needed for our staff.” The new address and phone numbers are:
143 Rosemont-Ringoes Road
Stockton, NJ 08859
877-MGD-TEST
Fax 609-397-3967
We are confident you will find this information a valuable resource for your day to day activities.
MGDServices Has a New LocationMGDServices has relocated to a new location in Hunterdon County, NJ. Gretchen Gunn states “Our new location keeps us close to our clients while adding the additional office space needed for our staff.” The new address and phone numbers are:
143 Rosemont-Ringoes Road
Stockton, NJ 08859
877-MGD-TEST
Fax 609-397-3967
About MGD Services
Product / Service Information
MGD Services, Inc. is a woman owned business that supplies consulting professionals to corporate IS departments in support of computer systems development projects. We supply well-trained, seasoned personnel to perform all tasks involved in the entire project life cycle for computer systems development.
MGD Services provides our clients with candidates that have been carefully screened, interviewed, references checked, and matched to our clients needs for their projects. MGD has many years of experience in IT systems development and we know how to separate the good candidates from the poor candidates.
We at MGD Services pride ourselves on the consistent quality of the candidates we present to our clients. We provide qualified candidates that do not waste our client’s time on unwarranted interviews. When we send a candidate to a client, they can be confident that the candidate meets or exceeds their project needs.
We supply our clients with candidates for all phases of the project life cycle development process.
Our personnel include:
§ Project Managers § Application Developers
§ FDA CSV Auditors § Testers
§ Business Analysts § Database Architects
§ QA Managers § Automation Test Specialists
§ System Designers § FDA Validation Analysts
§ QA Analysts § DBA’s
§ Network Specialists § Technical Writers
These personnel are involved in computer systems development projects from inception through the project lifecycle into production and on into system maintenance and enhancements. They work closely with both the system development staff and the end user community to provide a system that meets the client needs and the project requirements.
MGD Services understands the benefit of having the best in testing technology for today's enterprise needs. MGD Services partners with Mercury Interactive and Compuware. MGD Services has both Mercury and Compuware Certified QA analysts and test specialists who can provide quality assurance automated testing expertise for our client’s software development projects. We can support our clients in reviewing and understanding all automated testing products.
MGD Services, Inc. is a woman owned business that supplies consulting professionals to corporate IS departments in support of computer systems development projects. We supply well-trained, seasoned personnel to perform all tasks involved in the entire project life cycle for computer systems development.
MGD Services provides our clients with candidates that have been carefully screened, interviewed, references checked, and matched to our clients needs for their projects. MGD has many years of experience in IT systems development and we know how to separate the good candidates from the poor candidates.
We at MGD Services pride ourselves on the consistent quality of the candidates we present to our clients. We provide qualified candidates that do not waste our client’s time on unwarranted interviews. When we send a candidate to a client, they can be confident that the candidate meets or exceeds their project needs.
We supply our clients with candidates for all phases of the project life cycle development process.
Our personnel include:
§ Project Managers § Application Developers
§ FDA CSV Auditors § Testers
§ Business Analysts § Database Architects
§ QA Managers § Automation Test Specialists
§ System Designers § FDA Validation Analysts
§ QA Analysts § DBA’s
§ Network Specialists § Technical Writers
These personnel are involved in computer systems development projects from inception through the project lifecycle into production and on into system maintenance and enhancements. They work closely with both the system development staff and the end user community to provide a system that meets the client needs and the project requirements.
MGD Services understands the benefit of having the best in testing technology for today's enterprise needs. MGD Services partners with Mercury Interactive and Compuware. MGD Services has both Mercury and Compuware Certified QA analysts and test specialists who can provide quality assurance automated testing expertise for our client’s software development projects. We can support our clients in reviewing and understanding all automated testing products.
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