When dealing with Title 21 CFR Part 11 there are three primary areas a research site, sponsor, or CRO must think about. Florence works with all of our clients to map out each of these core areas and how they apply to their unique circumstances.
Features of Your System – Assurances for audit trail functionality, electronic signatures, security and data integrity, records retention and file formats are a few of the features that must be in place for an electronic system and/or process.
Standard Operating Procedures – Standard Operating Procedures (SOP’s) are required to be established and maintained to govern and describe exactly how things are done at that research site, sponsor, and/or CRO.
System Validation – Controls must be in place that allow research sites, sponsors and CROs to identify when the system doesn’t function as per its intended use. Here you should be utilizing your SOP’s and industry best practices to facilitate the validation process.