Pharma Software Validation

Pharma companies dread computer system validation. It can be the most time-consuming, resource-intensive activity that’s required for regulatory compliance. But now there’s a faster, easier way to get it done.

Regulators like the U.S. Food and Drug Administration (FDA) require computer system validation in the pharmaceutical industry. However, they don’t specify how it should be performed. That makes meeting pharma software validation requirements especially difficult. MasterControl Quality Excellence’s patented tools and proven methodologies enable pharma companies to cut validation times from months to days.

Free Resources

8 Tips for Compliant and Quick Software Validation

Frequently Asked Questions About Pharma Software Validation

What is FDA software validation?

MasterControl’s validation software for pharma

Manufacturers of FDA-regulated pharmaceuticals must validate their electronic systems to comply with 21 CFR Part 11, among other regulations. The FDA requires evidence of validation in the pharmaceutical industry. Companies must first document how they intend to validate and then prove that they've done it in accordance with that documentation.

What are the main types of validation in pharma?

Validation in pharmaceutical industries takes two forms: computer system validation and process validation. The former is defined above. The FDA defines the latter as the collection and evaluation of data, from process design stages through commercial production, which establishes evidence that a process can consistently deliver a quality product.

How do you validate a software program?

Pharma software validation entails six steps:

Evaluate the software vendors’ development and testing practices.

Define your risk framework.

Establish effective change control.

Stay current with vendors’ upgrade releases.

Leverage – but don’t duplicate – the work and documentation the vendor has already generated.

If necessary, perform additional testing.

Free Pharma Software Validation Resources

Select the free pharma validation resources you’re interested in downloading

Industry Brief: 8 Tips for Compliant and Quick Software Validation
e-book: Connecting Quality Data to Overcome Pharma's 3 Toughest Challenges
Ultimate Guide: The Ultimate Guide to Pharmaceutical Quality Management
Trend Brief: 2024 Pharmaceutical Industry Trends

Validation Software for Pharma

Computer system validation doesn’t have to drag on for months. With MasterControl, validation can often be completed in a matter of hours.

The most efficient pharma software validation processes in the industry.

You can save time and effort by taking advantage of the testing and documentation we provide. Our tools and consultants use a risk-based approach to tell you where to focus your computer system validation efforts.
A proven computer system validation approach designed for regulatory compliance.

Our trusted tools and methods have undergone multiple regulatory inspections without a single finding.
Revolutionary risk-based validation software for pharma.

Our patented Validation Excellence Tool (VxT) uses a risk-based approach to tailor validation to your business needs and how you use MasterControl software solutions.
Complete computer system validation documentation.

All the documentation you need to perform a compliant pharma software validation is included with our validation services. This includes your validation plan, transfer operation qualifications (TOQ), transfer performance qualifications (TPQ), installation qualification (IQ) protocols, and the final validation report, among other documents.
Experienced computer system validation consultants.

MasterControl’s seasoned validation experts guide customers through their initial validation effort and prepare them for future computer system validation projects.