VaLogic

Our VaLogic Doggie plushies have been exploring Annapolis to prepare for the upcoming Maryland Tech Council's CRC BBQ on the Bay event, held at the beautiful Chesapeake Bay Foundation Headquarters, the Philip Merrill Environmental Center.

Visit our table from 5:30 PM to 7:30 PM to meet Laura Guida, our Director of Business Development, and learn how VaLogic Bio can streamline your GMP compliance needs. Don’t miss out on taking home one of the VaLogic stuffed animals, because science and smiles go hand in hand!

See you by the Bay!

Is your facility monitoring system audit-ready 24/7?

With growing scrutiny on data integrity (ALCOA+) and Annex 1, manual checks and disjointed sensors just don't cut it anymore.

LogiPoint® is a GMP cloud-based SaaS for monitoring critical lab equipment and production environments, built for life sciences, ready for the strictest regulators.

Why LogiPoint®?

✅ 21 CFR Part 11 compliance out of the box (audit trails, e-signatures, role-based access)
✅ Real-time alerts for freezers, incubators, and production suites
✅ Cloud-native = no on-site servers, faster validation
✅ Scales from one lab to global manufacturing

Stop chasing data. Start trusting it.

👉 Set up a LogiPoint® consultation today: https://hubs.li/Q04jmLNk0

MYTH: If it passed validation, it doesn't need to be validated again.

REALITY: Validation is a lifecycle commitment, not a one-time event.

Equipment ages. Processes drift. Software gets updated. Facilities change.

Any of these can invalidate your original qualification, even if nothing was formally changed.

Revalidation triggers your team should be tracking:
● Equipment moves or modifications
● Significant process changes
● Repeated failures or unexplained deviations
● Extended periods of non-use
● Changes to regulatory requirements

A passing validation report from five years ago is not proof of current compliance. It's a historical record.

How often does your team formally reassess validation status?

Most validation programs fail before the first protocol is written.

Here's what IQ, OQ, and PQ actually require - and where teams go wrong at each stage.

IQ (Installation Qualification) Confirms that equipment is installed correctly and matches design specifications. Common gap: Assuming vendor documentation is sufficient. It's a starting point, not a substitute for your own verification.

OQ (Operational Qualification) Verifies that equipment operates as intended across its defined range. Common gap: Testing only the "expected" operating parameters. Challenge the edges.

PQ (Performance Qualification) Demonstrates consistent performance under actual production conditions. Common gap: Treating PQ as a one-time event. Performance must be monitored over time.

The biggest validation mistake? Rushing through IQ to get to PQ. Each phase builds on the last. Skip steps, and you're not validated - you're just documented.

What phase causes the most rework in your validation programs?