The policies, procedures and templates are priced at a fraction of the cost to develop such documents. Customization services are also available.
If you are interested in purchasing documents, please contact BPA
| Procedure Title | Purpose | Comments |
| Assessing and Achieving Compliance with 21CFR Part 11 | To
define the process for determining if Part 11 applies, assessing
compliance with the regulation, and creating a remediation plan. |
None. |
| Determining 21 CFR Part 11 Compliance for Existing Systems | To provide checklists to be used to 1) determine if a system needs to comply with Part 11; 2) determine compliance or non conformance of a system with each of the Part 11 regulations. | None. |
| Management of Electronic Records | The purpose of this procedure is to define the process for the creation, management and retention of electronic quality records. | None. |
Creating an Electronic Record |
The purpose of this work instruction is to define acceptable standards for recording data and/or changing electronic quality records. | None. |