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Pharma

Every check documented as it happens, audit-ready in place.

Quality and facilities engineering teams at pharma and biotech sites keep utilities integrity, cleanroom checks, and equipment history on one attributed record, mapped to FDA cGMP, EU GMP, and PIC/S expectations wherever the site sits.

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Where it runs

Every utility loop and cleanroom keeps its reading, its reviewer, and its approval on one attributed record.

Cleanrooms · WFI loops · clean steam · utility vessels

Part 11attribution on every record
ISO 14644requalification on schedule
ASME BPEhygienic piping history
21 CFR Part 11cGMP 21 CFR 210/211EU GMP Annex 1ASME BPEISO 14644GAMP 5

The value map

Four records an investigator will find waiting.

An investigator asks for the record, not for how hard the team worked. These four exist before the request, each one a module doing one job the quality system already requires.

02 layers · scroll to stack

  1. 011 / 2

    Cleanroom rounds signed in place

    intelliINSPECT schedules ISO 14644 requalification checks, HEPA integrity tests, pressure differentials, and EU GMP Annex 1 environmental rounds by room, captured offline in gowned areas and signed off where the work happens.

    Water and steam loop thickness on record

    intelliNDT holds UT readings, corrosion rates, and remaining life for WFI, purified water, and clean steam piping against ASME BPE, so a thinning tube surfaces on the record while rouge stays invisible on the outside.

  2. 022 / 2

    Utility vessel calls with the basis kept

    intelliINTEGRITY runs API 580/581 risk-based inspection and API 579 fitness-for-service on boilers, ammonia refrigeration, and solvent systems, and keeps the basis behind every run, repair, or replace decision.

    Contractor work attributed to Part 11

    intelliCOMPLY carries permits, LOTO, and JSAs for maintenance inside the envelope on an append-only trail, with the user, timestamp, and signature attribution 21 CFR Part 11 review looks for.

One attributed record

The proof is documented as it happens, ready before the auditor arrives.

Field to audit

A WFI loop survey, gown-up to closeout.

  1. 01

    Capture in the suite

    The inspector gowns in and logs UT readings at each CML on the loop, offline, because signal rarely survives a classified suite. Photos and weld references sync at the airlock with attribution intact.

  2. 02

    The recompute

    On sync, corrosion rate and remaining life update per location. A thinning elbow raises the run, repair, or replace question months before the shutdown, not during it.

  3. 03

    The proof, pre-assembled

    When FDA or EMA arrive, the loop history exports with reading, reviewer, and approval attached. No logbook archaeology, no reconstruction the week before the closing meeting.

How it runs

The modules behind the record.

intelliINSPECT

Holds ISO 14644 requalification and EU GMP Annex 1 rounds to their intervals, room by room, offline in gowned areas.

intelliNDT

Keeps thickness, corrosion rate, and remaining life for hygienic piping against ASME BPE.

intelliINTEGRITY

Runs API 580/581 risk-based inspection and API 579 fitness-for-service on utility vessels with the basis kept.

intelliCOMPLY

Preserves an append-only approval trail with the attribution 21 CFR Part 11 review expects.

Evaluation path

Give every reviewer the right evidence.

Product evidenceImplementationIntegrationsSecurity and trustBuyer resources
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Pharma · next step

Your next audit is already on the calendar.

Bring one water loop or one cleanroom schedule and we will map capture, review, and export against your quality system.

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Answers

Pharma questions

01Does intelliSPEC support 21 CFR Part 11 electronic records and signatures?

intelliSPEC captures every inspection, reading, and approval as an append-only record with user, timestamp, action, and signature attribution, the structure 21 CFR Part 11 review examines. Your quality unit qualifies the system within its own Part 11 program. intelliSPEC organizes the record rather than certifying compliance on your behalf.

02How do WFI and purified water loop inspections work in intelliSPEC?

UT thickness points are set at CMLs along the loop in intelliNDT, and each survey updates corrosion rate and remaining life per location against ASME BPE expectations. A thinning reading surfaces the repair decision before the next shutdown window.

03Can intelliSPEC schedule ISO 14644 cleanroom requalification?

Yes. Classification checks, HEPA leak tests, airflow and pressure differential readings, and requalification intervals are held per room to ISO 14644, with due, overdue, and completed items visible before an inspector asks.

04Does intelliSPEC work offline inside classified cleanrooms?

Yes. Inspection and NDT capture run fully offline, so EU GMP Annex 1 rounds and UT surveys proceed inside gowned suites where devices rarely have signal, then sync with full attribution once back at the airlock.

05Can intelliSPEC track rouge and passivation history on stainless systems?

Yes. Derouging and passivation events, surface finish checks, weld records, and corrective actions are retained per asset against ASME BPE, so the stainless system's history reads as one thread instead of scattered databooks.

06How does intelliSPEC fit a GAMP 5 validation approach?

intelliSPEC is configurable software your team validates under its own GAMP 5 and EU GMP Annex 11 program. Configuration records and the audit trail support that validation effort, and intelliSPEC organizes the evidence rather than certifying compliance for you.

07What software do pharma facilities use for equipment integrity and utilities inspection?

Pharma engineering teams increasingly run visual rounds, UT thickness, and risk-based inspection on one platform instead of paper logbooks and spreadsheets. intelliSPEC maps utility vessels and piping to API 510 and API 570 and hygienic systems to ASME BPE, with the record kept audit-ready across sites.