Master recipes. Versions. Changes. Second lines. Recipe management. Every limit, with its evidence.

The master batch record is executable configuration in Seal: instructions, required fields, calculations and review steps on the same platform as materials, equipment, QC and quality. Seal represents it as reusable stages and steps with explicit behaviour rather than page layout.

The approved workflow checks each prerequisite before a step starts: procedure version, operator qualifications, material and equipment status, and line clearance. Each controlled value has a range and a configured response: continue, require verification, repeat the observation, create a sample, place the batch on hold or open a deviation. The original value and the system’s evaluation stay visible even when the authorised process continues.

Yes. A critical process parameter keeps its justified range, the quality attribute it controls and the studies that established it. Development and manufacturing share linked definitions and evidence in Seal, so a manufacturing recipe can reference the runs behind each parameter. Development results do not by themselves authorise manufacturing execution.

Seal resolves effectivity for the product, site, market and start date when the batch is created, and records the versions selected. A later change does not rewrite work in progress. If an urgent change must apply to live work, authorised users define the transition point and approve the additional instructions, and both the original and changed course remain visible. A revised route, limit or yield rule becomes a new recipe version for the lots that follow; every earlier lot keeps the recipe it was made under.

A finding becomes a new version of the process, carrying its requirements, tests and approval. Selected user acceptance tests (UATs) run in a background simulation when a change is prepared for review. Publication requires current passing results for the required UATs; missing or stale results are not started automatically. Calculations such as yield, potency adjustment or material balance are versioned process logic, so a changed formula is a controlled revision tested against representative cases before it takes effect.

Give Neil a procedure or master batch record. It proposes the steps, fields, calculations, material and equipment requirements, and review gates in Seal. Process experts check the source mapping and resolve assumptions before testing and approval. Nothing Neil produces takes effect until a qualified person has reviewed it, and operators run only the approved version.

No. Every connection Seal Edge makes is read-only, and nothing in Seal can send a value, a setpoint or a command to a machine. Historian and control-system connections read values; they do not change setpoints, acknowledge alarms or operate equipment. DCS, PLC and historian systems remain authoritative for process control.

A permitted copy of the configured process starts the receiving site as a separate draft. It keeps the steps, fields, calculations and references, and none of the sign-offs. A site-specific process binds the platform process to that site’s equipment, scale and facility constraints, so the differences from the source are recorded rather than implied. Copying is not automatic site readiness.

You can start with one process, alongside the MES, LIMS or QMS you already run. Once we agree the process evaluation scope and receive the required inputs, see the first working configuration and supporting validation pack within 48 hours.