Outsourcing companies

What, when and where Almost anything can be outsourced. Companies can get involved with outsourcing at several different levels. 

A. Example I Role and Use of Outsourcing Companies during the Development of a Process... 

Prepare a written statement of requirements for the outsourced company to tender against (make sure there are no misunderstandings before work starts). 

A process of disentanglement usually has to be imdertaken in order to transfer systems to the outsourcing company. Compliance issues can be divided into the following categories ... 

The operation and maintenance of regulated computer systems has already been discussed in Chapter 12. The outsourcing company should effectively manage these requirements ... 

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 ... 

The administration of access controls is usually passed to the outsourcing company. Access must be restricted to authorized users. Users may be from both the pharmaceutical or healthcare company and the outsourcing company. Access controls must protect iirformation from unauthorized modihcation (inadvertent or malicious). Extra controls may be required so that previously closed systems do not unwittingly become open systems. Security in general is discussed in Chapter 12. Open and closed systems are discussed in Chapter 15. 

Approve the outsourcing company s Quality Plans so that compliance requirements are visible and understood from the outset. 

Manage modifications through change control (ensure appropriate level of participation from pharmaceutical, healthcare, and outsourcing companies). 

Ensure outsourcing company completes and properly organizes all validation documentation. 

Keep the outsourcing company np to date with regulatory developments and comphance expectations (possibly condnct tailored training programs). 

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

What will be the impact on client staff Will they transition to the outsource company What might the impact be Will they be reluctant to hand over services ... 

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 outsourcing company should be aware of the potential additional costs to simply paying for a package of work. Someone from the parent company has to manage the process, and this can involve several stages ... 

The longer the supply chain, the greater the need for demandsensing capabilities. With global outsourcing, companies have built long supply chains that translate rather than sense demand. As a result, the use of sensor data, market data, or temporal data (e.g., weather, traffic, etc.) to sense and reduce latency is an opportunity for most companies. 

A contract model between the outsourcer and the outsourced companies can be as follows ... 

I Reporting comments to a representative of the outsourcing company I Imposing financial penalties on the outsourcing company Application of other sanctions (non-financial)... 

Figure 5.5 Methods used by companies to solve problems resulting from cooperation with an outsourcing company providing logistics services Source Own study.

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