00encompass360
Six independent sources on one time axis. Nothing is copied, nothing is transformed, and every source record stays exactly where it is.
Two decades in the field: PharmEng OPEX 360° → JCA enCompass360° with BatchSAFE™ → Synerlytics encompass360.
Live · 1,005 real batches · open it
01Batch at a Glance
A production record review starts with one question: does this batch need my attention? Batch at a Glance answers it before anything else loads: disposition, the critical quality attribute against its specification, whether theoretical yield tripped its §211.192 trigger, and which critical process parameters departed from the golden master.
Everything else is one click away and stays out of the way until asked for. This is review by exception: the point is not to read two hundred pages faster, it is not to read them.
The regulator has a name for this screen. MHRA calls it an exception report: “a validated search tool that identifies and documents predetermined ‘abnormal’ data or actions, that require further attention or investigation by the data reviewer.” The live demo builds Batch at a Glance as that tool: a defined rule set, versioned, with the version that fired stored on every exception. What the reviewer does with an exception is recorded in §211.192’s own words, flagged, in review, explained, unexplained, investigation opened, and explained requires a note. The disposition stays with the quality control unit.
Batch against batch, or batch against a golden master computed from the distribution of released batches, not one hand-picked reference run. Batches align with time zero at each ISA-88 phase boundary taken from the recipe system. The public demo cannot show this: its dataset has no phase column, so it aligns by percent of run and says so on the axis.
The trend shown against what the batch actually produced: dissolution, weight variation, yield, impurities. Cause and consequence on one screen.
“The investigation shall extend to other batches of the same drug product.” The sentence is a control: the same rule, the same band and the same CPP run across every other batch of the product, listing where the departure recurs, with the batch under review kept as the comparison overlay.
Drag on the trend to make a window, a bounded stretch of the axis read across every CPP at once; click a sample to see every layer at that moment. A note is attributable and time-stamped: who, what, when and why. Pinning a review captures it exactly as displayed, rule version, band, windows, exceptions, states and notes, hashed, so it reads the same in five years as it did on the day.
“A written record of the investigation shall be made and shall include the conclusions and followup.” In the live demo, setting a discrepancy to investigation opened creates that record: the trigger, the related batches, the notes, conclusions and follow-up, exportable as a document. The demo shows the hand-off to a QMS or ticketing system as a design; which systems a production deployment connects to is agreed per site. An investigation is never closed here; the QMS closes it.
The sources keep their audit trails and encompass360 reads them in place. It keeps its own for the review layer, with who and when; the demo records every state change, note, pin, export and investigation action, and the production scope is settled in validation. Every control and every figure on the demo screen explains itself on hover, in the regulation’s words where it has them.
Words we use, and why: exception report, discrepancy, window, note, pin, seal →
02Interfaces
The integration list is the product. A contextualised view is only possible if every source is reachable, and these are the ones already in production.
The review layer is read-only. Batch at a Glance, BatchSAFE and reporting read every source in place and write nothing back, so adding them does not change the validated state of the historian, the MES or the LIMS, and removing them leaves every source record where it was. Connection topology and direction for a given site are answered in the deployment conversation, not asserted here.
| Layer | Systems | What encompass360 reads |
|---|---|---|
| Historians | OSI / AVEVA PI, Proficy | Analog process data and PI Asset Framework, read in place. |
| SCADA / HMI | FactoryTalk View SE, Ignition | Alarms and events, inline against the trend that caused them. |
| Operations | MES / EBR, recipe management | Phase boundaries and alarm limits from the recipe system, not hand-drawn. |
| Quality & lab | LIMS, QMS | The result that decides whether the batch ships. |
| Facility | BMS / EMS, serialisation | Room conditions for the same window as the batch. |
| Connectivity | OPC DA/UA, MQTT, MS SQL | Everything else, including the relational stores that hold the text a historian cannot. |
03What it does
Batch-to-batch and golden master, side by side. Alarms, audit trail and plotted values aligned in one grid. Multi-source layering with full export. 200-plus page batch reports collapsed into one view.
Process and product trending with early-warning icons. Event tri-panel investigation relating events to process shifts. Out-of-trend alerts, for stability among others. Statistical process control monitoring and alerts.
Univariate and multivariate statistical analysis. PCA, regression, correlation matrices and Cp/Cpk. Multi-phase analysis for chromatography data. Stability and expiration dating, linear and non-linear models.
Browser and PDF, automatically emailed on schedule. Pulls from historians, SQL, MES and more at once. Dramatically less report-development time. Read-only output that keeps source data untouched.
Compare revisions and roll back in a click. Domain-secured authoring; only approved recipes reach production. S88 batch and recipe management, downloaded per batch. Work instructions on the HMI with a full audit trail.
IP cameras triggered by any OPC or digital event. Batch number, CPP and operator ID overlaid into the clip. Process-and-store keeps only the events that matter. Frame-by-frame playback tied to line running or stopped.
Also in the box: self-service, role-based dashboards · ad hoc investigational analysis · cloud data exchange with partners · graphical lot genealogy · Part 11-compliant capture of paper records.
04Connects to what you run
encompass360 reads your existing systems where they sit. No rip-and-replace, and no copying data into yet another silo. Sixteen systems across eight families, grouped by the one you already have.
The analog and digital process data itself, plus the asset model that gives a tag its place in the plant. Read in place: the historian stays the system of record.
Alarms and events, with the operator actions around them, put inline against the trend that caused them rather than in a separate alarm report.
The relational stores that hold what a historian handles badly: audit trails, batch information, user records. This is the other half of the layered architecture.
Phase boundaries and alarm limits taken from the recipe system, not hand-drawn on the chart. ISA-88 procedure, unit procedure, operation and phase.
The result that decides whether the batch ships, and the deviation and CAPA records that decide whether it ships on time.
Release status and the material master, so a documented disposition and a physical stock status can be reconciled.
Room conditions for the same window as the batch: temperature, humidity, differential pressure, particle counts.
Everything else. OPC for classic and modern automation stacks; MQTT into a unified namespace for plants that have already made that move.
05A report for every question
Twelve families of reports spanning production, quality, validation, performance and compliance, each built once from data that stays where it lives.
Electronic Batch Record · Genealogy · Release · Campaign throughput
Deviation / NCR · CAPA · OOS / OOT · Change control
IQ / OQ / PQ · CSV · Process validation · Cleaning validation
CPP trending · Cp / Cpk · Yield · Golden-master comparison
OEE · Downtime analysis · Maintenance · Calibration
Temp & humidity · Particle counts · Differential pressure · Microbial
Certificate of Analysis · In-process testing · Finished product · Stability
Lot genealogy · Supplier batch trace · Recall readiness
Work-in-progress · Finished goods · Expiration tracking
ALCOA+ checks · Audit-trail review · E-signature · Changed since original entry (Annex 11 §8.2)
KPI dashboards · Cost per batch · Right First Time
APQR / APR / PQR · Continued Process Verification · FDA inspection support
06Proven on the line
On a consumer-pharma line in Guayama, Puerto Rico, a data-centric encompass360 deployment replaced a fully manual process in 2005, then ran for the next fifteen years. In 2023 the same site brought the team back to modernise the line for its next era: virtualisation, thin clients and Part 11 upgrades. No data-integrity findings in fifteen-plus years of continuous operation.
The figures are the client’s own, from the Guayama line, 2005–2023. They are one site’s numbers, stated as such, and available with their basis under NDA.
07Verification engine
A built-in engine continuously checks your records for missing data, broken links and gaps, then alerts your team, in a fraction of the time a manual review takes and without the human error. Source data is read where it lives, never copied, so there is nothing to corrupt.
Built to ALCOA+ and 21 CFR Part 11: why that decides the batch →
08Deploy anywhere
Built on industry-standard components, it keeps a small footprint and deploys stand-alone or across the enterprise, on the floor or over the network. Machine builders and systems integrators embed the same engine directly into their own equipment and SCADA/HMI solutions.
For the OT review: the review layer is read-only and writes nothing to any source. On-prem, private cloud or hybrid; SSO / SAML and role-based access on the Enterprise tier.
09Video investigation
IP cameras along the line, recorded to a dedicated store and indexed to the same time axis as the process data. Drag the cursor across a temperature excursion and see, from several angles, what the line was doing at that moment.
Other platforms sync video to a downtime event for OEE. This ties it to a batch record, alongside alarms, recipe steps and the audit trail, for a regulated deviation investigation. That is the distinction, and it is the one worth making.
10Where it runs
A quality reviewer investigating a batch that ran three weeks ago sits at a workstation with a large screen and compares batches side by side. Maintenance carries a tablet onto the floor. Both are looking at the same record, and neither should be handed the other one’s tool.
11See encompass360 on a
A live walkthrough on a process like the one you run, plus a Q&A with the team that builds it. Those numbers started with one line and a first project; see what the first ninety days look like on yours.