The challenges that the industry faced in 2020 related to the pandemic impacted all functional areas including validation. Challenges discussed in this paper related to the pandemic can be managed and the risk significantly reduced by implementing strategies that enable the continuity of validation activities. Partnership with the quality organization is critical to ensure that needed changes to processes and procedures are adopted to enable simplicity and continuity of validation activities during a pandemic. Processes and procedures related to electronic document management systems should be revised and simplified as needed to eliminate unnecessary bureaucracy which can have a negative impact on keeping validation activities on schedule. Finally, it is critical that validation challenges are managed with a well-defined strategy that enables continuity of validation activities. Failure to implement an adequate strategy can have a negative impact on the validation team’s ability to deliver for the business.
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