Service-level agreements

Service level agreements verified against the contract and approved... 

Change Any variation or alteration in form, state, or quality. It includes additions, deletions, or modifications impacting the hardware or software components used affecting operational integrity, service level agreements, or the validated status of applications on the system. 

Supply management has to ensure a smooth and uninterrupted supply of raw materials by defining dear service level agreements with suppliers, planning raw materials, issuing procurement orders, and tracking and managing supplier performance. 

Formal agreements regarding operational support (e.g., contracts and service level agreements) must be established defining responsibilities and accountabilities. 

Check scope and records of any service level agreements. 

Commercial contracts and service level agreements for operation and support of computer systems should be established prior to their use. 

All documentation furnished by the supplier should be available. User manuals, as-built drawings, instrument calibration records, and procedures for operation and maintenance (including calibration schedules) of the system should all be checked to verify that they are suitable. Supplier documentation should be reviewed for accuracy in its specifications of the various versions of software used and approved as fit for purpose. It is recommended that checks are made to verify that contingency plans, SOPs, and any Service Level Agreements (SLAs) are also in place. Any specific competencies supposed to be acquired before the IQ/OQ/PQ through training should also have been achieved — these records should be checked. 

Service organizations should set up processes to collect and analyze operational performance data. Examples of performance charts are shown in Chapter 12. Performance metrics to be tracked and acceptable service levels to be met should be specified in Service Level Agreements. Performance charts might include monitoring the training and help desk activity as indicted in the bullet points above. 

Contracts should be established with aU suppliers. For standard items of equipment and software this can take the form of a purchase order. For support services it is common practice for users of computer systems to establish a Service Level Agreement (SLA) with their supphers. 

New owner conduct Supplier Audit on divesting organization as external service provider Formal contract of supply required Service Level Agreement established for maintenance and inspection support... 

Contracts and Service Level Agreements (SLAs) User procedures... 

A procedure should be developed describing how to handle requests by regulators for documentation. Where requested, access to master (or copies of) documents (including raw data such as test evidence) should be provided within reasonable time frames, normally 24 to 48 h depending on circumstances. The Canadian Health Products and Food Branch Inspectorate, for instance, requires records to be accessible within 48 h. The FDA has similar requirements for off-site paper-based archives. Service Level Agreements between central support functions and sites should define the service levels for access to documentation. 

In the case of outsourcing the support for the hardware platforms and network that run the chromatography data system software to the internal IT Department, a Service Level Agreement (SLA) has to be written. This SLA should cover procedures such as ... 

Verify Sample Data and System Parameters, i.e., Check against Source Records to Ensure Accuracy of Data within the RDB Involves Checking of Data Loaded Manually or via Automated Upload from Legacy Systems Software Backups and Restoration of Data Training Records of Users Routine Maintenance/Calibration Routines Provision of Service Level Agreements (SLAs)... 

Managing upgrades to the core LIMS, standard software packages, and operating systems Managing Service Level Agreements with the LIMS supplier... 

Alarm Response Procedures Out of Compliance Procedures Service Level Agreements Documentation... 

The support group for the system must ensure that adequate procedural documentation is in place to ensure that system continuity can be restored in the event of a system failure. Business Continuity Plans should be developed in line with relevant Service Level Agreements (SLAs) contracted between the business and the supporting IT organization. 

Backup and archive services are often outsourced to third-party organizations. Where this is the case, the third-party organization should be assessed in order to ensure that they have appropriate facilities and processes in place. Service requirements should be stated in appropriate contract documents or Service Level Agreements (SLAs). 

Process improvement participation Service Level Agreement performance monitoring Internal audit schedule... 

Aside from the contract, every effort should be made to include compliance and security service levels in the overall Service Level Agreement (SLA). Although difficult to quantify, it is important... 

Service Level Agreement A formal agreement, possibly contract, defining the services to be provided by a snpplier to a cnstomer. [Dehned for this book.]... 

Most research on QoS with respect to Web Services (e.g. [523, 625]) makes use of Service Level Agreements (SLA) between the companies involved. This is, however, not always possible, and new Web Services cannot be used immediately. 

Dan, A., Ludwig, H., Pacifici, G. Web services differentiation with service level agreements (2003), http //www-106.ibm.com/developerworks/ webservices/library/ws-slafram... 

Service Level Agreements. Service Level Agreements must be established between the user and supplier to ensure that the appropriate expertise and facilities are available to assess and implement changes, either as a result of defects or a change in business need. 

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