Outsourcing procedure

2 Outsourcing Procedure 4.3.2.1 Stage 1 Defining the Core Items 

Of high relevance is the clarification of the strategic importance of the item of interest (component or module), in other words, determining what position it has in 

the identification of core competencies plays an important role. If a firm possesses a unique position compared to its competitors, it is very likely that the firm possesses a core competence in producing particular products or technologies. These competencies are not of a physical nature, but capabilities, knowledge or processes that are inherent in the structure of a firm and thus difficult for competitors to uncover and copy (Mclvor 2000 Prahalad and Hamel 1990). Based on these facts, different items of a firm can be classified into three different groups (Mclvor and Humphreys 1997), as shown in Fig. 4.4. 

However, it is not self-evident that such an extreme position reflects a firm s particular situation, as a part inextricably connected to its environment therefore, aspects such as relations or long-term contracts within the industry might constrain the outsourcing decision (Mclvor 2000) (Fig. 4.5). 

2 Stage 2 Evaluate Relevant Value Chain Items 

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Methods for the Input from other CMs Outsourcing procedure... 

Outsourcing the development, validation, and performance of analytical methods in recent years has become a popular means to facilitate movement of product through the development process. A recent industry survey reported that the vast majority (86%) of the companies responding say they outsource analytical methods development to contract laboratories. Twenty-five percent of the responding firms indicated that they often or always contract out stability testing on development compounds [37]. There are important criteria to follow in working with contract laboratories to ensure that their methods validation procedures yield results that are consistent with those of the client company [38]. This topic will be discussed later in this chapter. 

Use of consultants (if appropriate) and assessment of their credentials—With all the outsourcing of activities and expertise occurring in pharmaceutical and other industries, it is not unreasonable to evaluate and document the qualifications of consultants who are involved in many activities in the pharmaceutical facility that can and will have CGMP impact on facilities, processes, and procedures. This would include but not be limited to some of the following examples ... 

IT-Enabled Services (ITES) The portion of the Information Technology industry focused on providing business services, such as call centers, insurance claims processing and medical records transcription, by utilizing the power of IT, especially the Internet. Most ITES functions are considered to be back-office procedures. Also, see Business Process Outsourcing (BPO). ... 

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

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 ... 

How will client and outsource company s processes, procedures, and systems be interfaced ... 

How will the outsource organization work with different client processes procedures and systems across regions and sites Who is accountable for the outsource organization s service performance, local sites, or contract managers ... 

How will total dependence on outsource company s processes, procedures, and systems be avoided In particular, how will the client company regain control of processes, documentation, and information in the event that a new service provider is selected or services are taken back inhouse ... 

The identification and selection process is only the first step. The second aspect involves monitoring the CSOs to ensure that the research studies are conducted according to the research protocol, that the results are obtained using appropriate techniques and procedures, and that the data generated are correctly recorded and documented in the study report. Many clients hire firms, such as other CSOs or consultants, to monitor outsourced research studies, particularly clinical trials and manufacturing projects. In doing so, the clients should use the same techniques to select and evaluate the monitors as they use to identify a CSO. Monitoring studies at CSOs should include but are not be limited to ... 

It is good business practice and a sign of due diligence to confirm (prior to outsourcing services) that the systems in place at and procedures followed by the external provider are compatible with... 

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