21 CFR Part 11 Compliant Software

Software Compliance with the Food and Drug Administration
Rules Governing Electronic Signatures & Records (21 CFR Part 11)

Background
In 1991 industry met with the FDA to determine how they could accommodate paperless record systems under the Current Good Manufacturing Practice (CGMP) regulations. This lead to the 21 CFR Part 11 which was published in 1997. The FDA´s intent with the ruling was to permit the widest possible use of electronic technology compatible with the FDA´s responsibility to protect public health.

21 CFR Part 11
21 CFR Part 11 was established by the FDA to define requirements for submitting electronic records and criteria for using electronic signatures. It covers how the records shall be produced to be deemed trustworthy and how electronic signatures shall be applied to make the FDA consider them equivalent to full handwritten signatures. Topics such as controls, security, audit trail and much more are covered.

Note: Software as such will not be approved by the FDA. It is the use of it and the systems supporting proper use that will be approved. It is always the end user's responsibility to use the system in such a way that compliance is not compromised.

FAQ
The new particle sizing software BI-PSD21 for the 90Plus will assist you to become regulatory compliant.

Why?
We have developed the new BI-PSD21 software so that it will meet 21 CFR Part 11 regulations.

How has the software been produced?
Our experts have based the development and documentation of the software on the life-cycle approach found in GAMP4 from ISPE. We have routines for development and review of software and the software has been subject to review and formal testing before release. Version and change control procedures are in place and applied to the ongoing improvements of the software. Please review the FDA compliance matrix to confirm that the BI-PSD21 software is developed to the highest standards.

What documents will support me?
You will get a validation binder. The purpose of the binder's contents is to assist you in validating the software after installation. Information in the binder will also help you to maintain a state of validation for the instrument. This is covered by the qualification documents supplied. In addition to this, design specifications are supplied to enable back-tracking of what tests are made to prove that the software is fit for its intended use. The Installation, Operation, and Performance Qualification documents (IQ, OQ, PQ) will also assist in proving that specified features are tested.

If needed, development documentation, procedures, User Requirement Specification, Design Qualification and test documents are available for audit at our premises in Holtsville, New York USA.

Can you help us to validate the software?
Yes. We offer on-site validation based on our validation package. The completed validation binder will form a powerful tool to achieve compliance.


Glossary

21 CFR Part 11 21 Code of Federal Register Part 11: Electronic records; Electronic Signatures.

FDA Food and Drug Administration of the United States of America

GAMP 4 Good Automated Manufacturing Practices 4

ISPE International Society of Pharmaceutical Engineering

IQ Installation Qualification (Documented verification that a system is installed in accordance with written and pre-approved specifications).

OQ Operational Qualification (Documented verification that a system operates in accordance with a set of written and pre-approved specifications throughout all operating ranges).

PQ Performance Qualification (Documented verification that the system is capable of controlling or performing the activities it is required to perform or control, according to written and pre-approved specifications while operating in its specified operating environment).