Workflow · Step 01 · Planning

From approved plans to scheduled activities.

Define your monitoring points, control sampling plan revisions and create sessions that guide operators through the required work.

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01 — SITE STRUCTURE

Define the site and its monitoring points.

Organize plants, departments, areas and rooms, then define the relevant sampling points, methods and acceptance limits. This shared master data provides the context for sampling plans and the activities generated from them.

Facility hierarchy

Plant

Department

Area

Room

Sampling point · class · limits · method

02 — Sampling plan

Define the work. Keep revisions controlled.

A Sampling Plan brings together the points to monitor, culture media, applicable methods and authorized BioSampler users. When changes are needed, BioTrends EM® creates a Draft revision with an automatically incremented version number. Previous revisions remain available in the plan history, preserving the record of how the monitoring program has evolved.

MONITORING SCOPE

Air
Surfaces
Water
Compressed gases
Personnel
Raw materials
Finished products

One planning framework, seven categories.
Create plans for air, surfaces, water, compressed gases, personnel, raw materials and finished products. Each category has dedicated fields and settings within a common revision and approval framework.

03 — Approval

Independent approval. A defined effective date.

An authorized user other than the plan’s author approves it with an electronic signature and defines its effective date. Approval sets the plan to Active, but it becomes available for scheduling only when that date is reached. Until a new revision takes effect, the previous approved revision remains applicable.

When a revised plan is approved, sessions based on the previous revision and scheduled after the new effective date are automatically cancelled.

04 — SESSION CREATION

Four ways to create sampling sessions.

Create sessions through the Scheduler, Plan Groups, directly in Core or from an online PDA, according to your operational needs.

Scheduler

Schedule monitoring activities in advance.

Create sessions from approved and effective Sampling Plans using day, week, month or timeline views. Configure recurring activities at the required frequency and view gowning validation, device calibration and culture media expiry dates to support planning.

Plan groups

Generate related sessions in one operation.

Plan Groups combine active Sampling Plans within the same department, including plans for different monitoring categories. Generate their sessions in a single operation, with timing and repetitions defined for each plan relative to the group’s start time. This simplifies the coordination of controls associated with a production batch, process phase or operational activity.

Directly in Core

Create individual sessions when needed.

Authorized users can create individual sampling sessions directly in BioTrends EM Core from approved and effective Sampling Plans. This supports one-off or unscheduled monitoring activities without using the Scheduler.

PDA (online)

Create sessions directly from the PDA.

When working online, authorized operators can create individual sampling sessions or generate sessions from a Plan Group directly on the PDA. Creation is confirmed with an electronic signature and recorded in the central system.

05 — Audit trail

Each action leaves a name and a time.

Creating a plan, approving it, scheduling a session, signing it — each of these is recorded with the user who did it and when. That audit trail is what supports inspection readiness: not a claim that nothing can go wrong, but a record of who did what, and when, that holds up when someone asks. Planning supports your compliant procedures; it does not replace your own validations or regulatory responsibility.

Plan created author · t+0

Plan approved second user · t+1

Session scheduled Scheduler · t+2

Signature recorded operator · t+3

What happens next

Once a session exists, the work moves into the field.

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The monitoring workflow

Next — Sampling