Software Validation Packages

Software Validation
If you are regulated by the Food and Drug Administration (FDA) and need to validate our software for 21 CFR Part 11 compliance, then our software validation product is right for you. Each of our products has been validated to assist you in being compliant with all Part 11 rules. By purchasing our validation package, you are helping to ensure you are prepared to pass an audit from the FDA.
Software Validation Includes
Installation Qualification (IQ) The IQ helps you install/configure the software correctly.
Operational Qualification (OQ) The OQ is a document with test scenarios and a signed cover page as proof of validation.
Link to Addendums A permanent link to the documents and particular version/revision of the validated software (including all addendums).
Software Validation Packages
Validation packages are valid at the site level. They are purchased once regardless as to the number of copies of the software you own at the same physical site. Each validation package comes with unlimited updates to the revisions within the current version of the software product you have purchased. Therefore, if you have purchased validation for QC-CALC RT 3.4.10 and Prolink re-validates at revision 3.4.20, you automatically qualify for the latest revision of the validation package without extra cost.

Upgrades to the validation package follow upgrades to the software which is being validated (specifically major or minor version number changes – i.e. 3.3 to 3.4 or 3.3 to 4.0). When you upgrade your software, the validation for that new version must be upgraded also. If your software and validation is covered under a software maintenance plan they will be upgraded at no charge.

Additional Software Validation Services

Also available but not included in the validation price are implementation and training packages. These are typically 2-3 days in length and are charged at the regular daily rate. Please see our onsite training option on the training page for pricing. The daily rate is the same whether we are doing training or validation.

Frequently Asked Questions About Software Validation

What is FDA computer system validation?
FDA (U.S. Food and Drug Administration) computer system validation (CSV) is a set of processes and activities that pharmaceutical, biotechnology, medical device, and other FDA-regulated industries must undertake to ensure that computer systems used in the production, testing, and management of products meet certain regulatory requirements. The primary goal of FDA CSV is to ensure data integrity, accuracy, and reliability within these computer systems to maintain product quality and patient safety.

What is software validation in the pharmaceutical industry?
It's proving your software performs reliably & accurately – crucial for patient safety & compliant products. Prolink streamlines the process, saving you time & headaches.

Who is responsible for software validation?
Ultimately, it's you, but Prolink is your partner! We offer solutions to help you install and configure our software correctly the first time, saving you time.
PlanPriceAdd to Cart
QC-CALC Real-Time 4.0 Validation Package$5,512.00
QC-CALC SPC 4.0 Validation Package$5,512.00
QC-Gage 4.0 Validation Package$2,205.00
SPC Office Buddy 4.0 Validation Package$2,205.00