Outsourcing defined

Any laboratory processes that are outsowced shall be identified within the QMS and the laboratory shall ensiue control over such processes. Such a control depends on the significance of the outsourced activities to the conformity of the result to defined requirements. The degree and extent of control exerted to outsourced activities is defined and documented to the QMS. 

Facilities and Equipment The technical experts who have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to the product are responsible for defining specific facility and equipment requirements. The equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and product mix-ups. It is important to remember that the GMPs place as much emphasis on process equipment as on testing equipment while most quality systems focus only on testing equipment. Control Outsourced Operations Quality systems call for contracts with outside suppliers that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms. 

Contracts should specify that the outsourcing company will maintain historical records for a retention period defined by the pharmaceutical and healthcare company. Means to ensure timely record retrieval also need to be established. Among other activities, record retrieval will be required to support ... 

It is important to agree at the outset on management and controls concerning security, confidentiality, intellectual property, documentation ownership, and compliance oversight. These topics should be included in legal contracts defining the outsourcing service to be provided. 

Where software development is outsourced, are there procedures in place to ensure that defined contractual agreements and quality of work are met ... 

Which organization is responsible for defining, reviewing, authorizationing, and implementing changes to the outsource organization s processes, procedures, and systems ... 

It is useful to understand the steps of the software development life cycle (SDLC) during a project. In fact, this approach is commonly used for implementation and validation even when commercial off-the-shelf software is involved [104]. It is also important to consider the economic aspects of the automation project [105]. A 10-step guide to success that emphasizes clearly defined project control in outsourced automation/information technology projects has been published [106]. 

We define outsourcing relationships to model cooperation in a customer-... 

The preclinical testing itself is performed by specialists in this field and is often outsourced to Contract Research Organization that should perform the studies conforming to the standards of Good Laboratory Practice (GLP in Europe as defined by the OECD). 

Besides these methods in a distributed, cooperative environment, consequent safety management has to be taken into account. Therefore, a role- and process-related access mechanism must be implemented that allows the administrator to define restrictions of modeling related to roles. The application of such technologies enables a company to manage outsourced development services. 

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