Validation concise summary

All validation activities should be planned. The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP). The VMP should be a summary document which is brief, concise and clear. The plan should contain at least the following validation policy, organizational structure of validation activities, summary of facility systems, equipment and processes to be validated, documentation format, planning and scheduling, change control and reference to existing documents. 

CICADs are concise documents that provide summaries of the relevant scientific information concerning the potential effects of chemicals upon human health and/or the environment. They are usually based on selected national or regional evaluation documents or on existing EHCs. Before acceptance for publication as CICADs by IPCS, these documents undergo extensive peer review by internationally selected experts to ensure their completeness, accuracy in the way in which the original data are represented, and the validity of the conclusions drawn. 

The VMP should be a summary document and should therefore be brief, concise, and clear. It should not repeat information documented elsewhere but should refer to existing documents such as policy documents, standard operating procedures (SOPs), and validation protocols/reports. The documentation format is illustrated in the VMP. 

Large accounts that may encompass entire manufacturing sites or multisite, nationwide businesses are particularly difficult to win. And, even if there are valid reasons to change, the process may take many months, or even years. A further problem is that often the ultimate decision on vendor selection takes place behind closed doors, without the vendor actually being present. Thus sellers have to rely on their primary buyers to conduct the sale on the seller s behalf (third-party selling). If the proposal is not clear and concise, with appropriate cost and benefit summaries, or if the primary buyer has not been properly sold to and does not fully comprehend the key details of the proposal, it is unlikely that the sale will proceed. 

As stated earlier, the conclusions capture the overall results of the activity. The conclusions section should be concise. This section is lifted from the body of validation summary and copied onto the cover page. 

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