“21 CFR Part 11 is the part of the code of USA’s federal regulation that establishes the US-FDA regulation to ensure electronic records and electronic signatures are trustworthy, reliable and equivalent to paper records”.
“Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system”.
“Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature”.
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Risk & GAP Analysis by reviewing the current computerised system validation SOPs, Policies and Processes
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Identify non-compliant areas
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Corrective and preventive action plan including the preparation of Validation Master Plan, System Requirements and Design Qualification, Qualification Plan, IQ, OQ, PQ and Qualification Report.
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Provide Best Practices Training
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Implementation of SOPs to handle Incident Report , Periodic System Reviews ,Backup and Recovery and Continuity Planning
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Risk & GAP Analysis by reviewing the current computerised system validation SOPs, Policies and Processes