Since 2010, FDA has embarked on a special enforcement and training of its investigators on 21 CFR 11.
Increasingly, Part 11 is an easy way for an investigator to cite a firm for failure to comply with the QSRs, GMPs, GLPs or GCPs. So if you don't want to receive a Warning Letter from FDA citing you for data quality issues – or you don't want your submission to FDA to be put on hold due to data integrity questions – then it's time to understand how FDA views Part 11 today, how it enforces Part 11, and why compliance with 21 CFR 11 is an essential part of FDA compliance today.
And yet, if you try to comply with Part 11 using outdated methodologies and "validate everything” interpretations, your costs will skyrocket and your risks will multiply.
Part 11 compliance today requires a cost-effective, risk management mindset.
Increasingly, Part 11 is an easy way for an investigator to cite a firm for failure to comply with the QSRs, GMPs, GLPs or GCPs. So if you don't want to receive a Warning Letter from FDA citing you for data quality issues – or you don't want your submission to FDA to be put on hold due to data integrity questions – then it's time to understand how FDA views Part 11 today, how it enforces Part 11, and why compliance with 21 CFR 11 is an essential part of FDA compliance today.
And yet, if you try to comply with Part 11 using outdated methodologies and "validate everything” interpretations, your costs will skyrocket and your risks will multiply.
Part 11 compliance today requires a cost-effective, risk management mindset.
