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Your Audit Trail Starts the Moment You Plug It In.

Most vendors treat compliance documentation as a service you schedule and pay for separately. Ours is built into the platform from day one — so your IQ/OQ/PQ validation, audit trail, and FDA 21 CFR Part 11-compliant records are continuous outputs of your monitoring system, not a project you manage on the side.

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Automated Compliance
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No Upfront Costs
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One System. Monitoring, Compliance, Protection.

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IQ/OQ/PQ Included. Not Extra.
Installation Qualification, Operational Qualification, and Performance Qualification documentation is prepared and delivered during your onboarding. Audit-ready before your system goes live — at no additional cost.
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FDA 21 CFR Part 11. From Day One.
Role-based access controls, encrypted data transmission, tamper-evident records, and a complete audit trail that logs every user action, alarm acknowledgment, and system change — built into the platform architecture, not added on later.
A digital presentation of a compliance report, featuring a central document titled 'Compliance Report.' Surrounding it are icons and labels highlighting features like data encryption, audit tracking, data storage, compliance status, and validation.
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Calibration That Manages Itself.
ISO 17025 pre-calibrated probes with a 2-year interval. Replacement probes ship automatically before your current ones expire. Calibration certificates are permanently linked to each device in the portal. Your calibration record never has a gap.
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Why we’re different

Most Vendors Bill You for Compliance. We Build It In.

Q/OQ/PQ is typically a separate engagement — scheduled, billed separately, and completed after your system is running. With PharmaWatch, it's included in every deployment. Your validation package is ready before you go live. No extra invoice. No waiting on a consultant's calendar.

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This is What Compliance on Autopilot Looks Like...

Your Audit Trail Builds Itself
Every reading, alarm, and corrective action logged automatically with timestamps and user IDs. Nothing requires manual entry. Nothing can be altered. Pull a complete inspection-ready report in 3 clicks.
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Validated Platform. Ready for GxP, GLP, and cGMP.
Built on a validated infrastructure that supports FDA 21 CFR Part 11, GxP, GLP, and cGMP. New versions validated before release. Auto-updates when regulations change.
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NIST-Traceable Calibration. Linked to Every Device.
Every probe carries an ISO 17025 certificate permanently linked to its device record in the portal. Replacement probes ship automatically before NIST expiration — no scheduling, no gap.
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It's automated

Always Audit Ready

Regulatory bodies don’t announce their visits. Joint Commission surveyors show up unannounced. FDA investigators arrive with specific requests. The facilities that handle these visits without stress aren’t the ones with the most compliance staff — they’re the ones with systems that document everything automatically.

PharmaWatch was built around that reality. From the moment a sensor is installed, every environmental reading is logged, every alarm is documented, and every user action is timestamped and attributed. Your compliance record is a continuous output of your monitoring system — not a project your team assembles before an inspection.

Compliance Standards We Support:

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FDA GxP, cGMP, and GLP
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FDA 21 CFR Part 11
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FDA HCT/Ps and CGTP
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AABB
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CAP
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JCAHO / Joint Commission
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CLIA
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USP 797/800
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CDC / VFC
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State Board of Pharmacy
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NIST-Traceable Calibration / ISO 17025
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IQ/OQ/PQ Validation Included
What's included

Everything Your Compliance Team Needs. Already Included.

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IQ/OQ/PQ at No Extra Cost
Full validation documentation prepared during onboarding. Not a billable service engagement. Not scheduled after the fact. Included in every deployment from day one.
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Tamper-Evident Audit Trail
Every alarm, acknowledgment, and system change is logged with timestamps and user IDs. Records cannot be altered after ingestion. Designed to satisfy FDA 21 CFR Part 11 requirements.
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Automatic Calibration Management
ISO 17025 probes with a 2-year interval. Replacements ship before expiration. Certificates linked to each device. No scheduling. No gaps. No coordination required on your end.
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Role-Based Access Controls
Administrators, QA leads, shift supervisors — each role gets appropriate access. Every login, every data view, every report export logged automatically for full FDA 21 CFR Part 11 traceability.
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Compliance Reports in 3 Clicks
Pull a complete, inspection-ready compliance report for any environment, any time range, any regulatory body — in under a minute. No manual compilation. No gaps to explain.
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Auto-Updated for Regulatory Changes
When federal or state compliance regulations are amended, PharmaWatch updates automatically. Your compliance posture stays current without any action on your end.
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View Compliance Documentation
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Frequently ask a questions

Find the answers here

Which compliance standards does PharmaWatch support?
PharmaWatch supports FDA 21 CFR Part 11, AABB, CAP, JCAHO, CLIA, USP 797/800, CDC Vaccine Storage Guidelines, and GxP, with built-in documentation and reporting designed for each standard.
Does PharmaWatch include IQ/OQ/PQ validation documentation?
Yes. PharmaWatch provides Installation Qualification, Operational Qualification, and Performance Qualification documentation templates to support your validation program and regulatory submissions.
How does PharmaWatch handle alarm response documentation?
Every alarm is logged with the time of excursion, the time of acknowledgment, the user who acknowledged it, and any resolution notes entered. This creates an automatic corrective action record for every event.
Can I generate custom compliance reports?
Yes. PharmaWatch allows you to generate reports filtered by date range, sensor, location, alarm type, or user, and export them in formats ready for FDA, CAP, AABB, and JCAHO inspections.
How does PharmaWatch manage sensor calibration compliance?
PharmaWatch tracks calibration schedules, alerts you when recalibration is due, and stores calibration certificates and records in your compliance dashboard, maintaining a complete calibration history for every sensor.
Is PharmaWatch a validated system under 21 CFR Part 11?
Yes. PharmaWatch is a validated system with documented qualification protocols. The platform meets electronic record and electronic signature requirements under FDA 21 CFR Part 11.
Is validation documentation really included at no extra cost?
Yes. IQ/OQ/PQ validation documentation is included in every PharmaWatch deployment — not sold as a separate professional services engagement. It’s prepared and delivered during your onboarding so your validation package is complete before your system goes live. No scheduling. No additional invoice.
How are compliance records stored and secured?
All environmental data and compliance records are stored indefinitely in a globally redundant, encrypted cloud infrastructure. Data is transmitted via SSL encryption and stored with encryption keys that prevent any record from being altered after ingestion. Role-based access controls ensure only authorized users can view or export records. The system satisfies FDA 21 CFR Part 11 requirements for electronic records and electronic signatures.

Protect What You Can’t Afford to Lose.

Our team will walk you through a live demo tailored to your facility — your equipment, your compliance requirements, your timeline. No generic slide deck.

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