GMP & GDP Software

for pharma and biotech

What does our software do?

From operators to QA, our software organizes GMP data and documents so teams know what to do, why it's important, and how to review it.

What makes it different?

Change workflows

We can't stress this enough. You can change your workflows yourself. No outside help needed.

We built it

Built by GMP consultants. We've seen the worst "pharma software". We avoided those mistakes & bad practices.

Operator data entry

Operators use tablets to enter data into digital forms. Ready for QA review in an instant. Straight to PQR & MR.

Stay organized and connected

Bring your team's work together in one shared space. Assign roles, distribute documents, create forms and centralize the data for (batch) review and management reporting.

The software is so flexible that it requires zero coding to amend workflows, forms and procedures when your process changes. It can tie into your email, automatically fill documents with data and alert on overdue CAPA's/deviations/complaints for example.

Is our software compliant?

United States Food and Drug Administration Logo in blue
European Commission EudraLex Logo vertical
World Health Organization WHO logo without text

Validated according to the U.S. FDA 21CFR11

Validated according to the EudraLex Volume 4 Part 1 - Annex 11 and Annex 15

Compliant with WHO TRS 1019 Annnex 3 (Appendix 5)

*PCS Intelligence comes with a validation package. The client is responsible for performing it's computerized systems validation and equipment qualification process. The validation package may aid in this process but may not be interpreted as a substitute.

Automate routine QA work

Leave the recurring tasks to us so you can focus more on what you do best.

Batch Records

Steps, weights, temperatures, etc.

Complaints

Batch number, contents, etc.

SOP's

Revision date, version, distributed to, etc.

collect & process

PCS Intelligence

QA · QC · Supervisors

Data output

Batch information for release, process trending, product quality review, etc.

Pricing

Prices start at € 250.- per concurrent user license per month. Volume discounts apply. We don't restrict access when you need an additional person using the system for a brief period of time.

Can I get a demo?

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We are happy to e-meet you and walk you through a demo! By filling in the form below you can reserve a timeslot in our agenda. We hope to talk to you soon!

Book a demo now, quick and easy!

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