Part 11 Remediation Plan
To comply with 21 CFR part 11 Electronic Records & Signatures, you will need to ensure that your records and data which holds any quality critical information will require validation and verified.
A preview of the the IOPQ Validation Protocol is available here:
You may purchase the full 10 page document in convenient Microsoft Word format including instructions for use below.
To comply with 21 CFR part 11 Electronic Records & Signatures, you will need to ensure that your records and data which hold any quality-critical information will require validation and verification. This Part 11 Remediation Plan is designed specifically where spreadsheets are in place that requires some kind of Validation, Security, Data traceability, and Formula verification needs to be proven through documented test scripts, this protocol has been tried and tested for this purpose and will help you in completing your Part 11 assessments.
*All prices quoted include a 500 word limit of email support.