Overview

Pestle Formulas is designed to function as an Intravenous Workflow Management System (IVWMS) — a technology platform that standardizes, verifies, and documents compounding workflows.

An IVWMS is defined as:

A pharmacy IV workflow system intended to facilitate safe preparation of compounded sterile preparations by standardizing workflow and providing a means to verify and document the compounding steps

In practice, this means:

• Standardized master formulation records

• Barcode or machine-readable verification

• Photo-based documentation

• Time-stamped activity logs

• Clear ownership and traceability

Pestle Formulas brings this structured workflow into your organization with centralized documentation and audit-ready reporting for use in all compounding or repackaging workflows.

Why IVWMS Matters in Compounding

Compounding errors often occur during:

• Manual transcription

• Ingredient selection

• Volume measurement

• Labeling

• Verification handoffs

An IVWMS reduces risk by:

• Guiding staff step-by-step through the formulation

• Verifying ingredients before addition

• Capturing image documentation

• Recording lot numbers and expiration dates

• Logging who performed and verified each step

This transforms compounding from memory-based workflow to documented process control.

Core Components of an IV Workflow Management System

1. Master Formulation Records

A master formulation record defines:

• Ingredients and concentrations

• Step-by-step preparation instructions

• Required supplies and filters

• Beyond-use dating guidance

• Labeling requirements

Pestle Formulas allows you to create, manage, and maintain standardized master formulation records (MFRs) across pharmacies.

Inspection impact: Master formulations are version-controlled and centrally managed, supporting consistency across shifts and locations.

2. Ingredient Verification

IVWMS systems verify source products using:

• Barcode scanning

• Machine-readable coding

• Controlled selection workflows

3. Gravimetric or Volumetric Documentation

Modern IV workflow systems may use:

• Gravimetric verification (weight-based confirmation)

• Volumetric photo capture (image documentation of syringe measurements)

Pestle supports structured documentation of these verification steps within the compounding workflow.

Note: When gravimetric analysis is used, systems should prevent entries outside tolerance limits. Pestle allows the build of custom QA/QC fields to be used to document these standards. Pestle does not interface with gravimetric analysis hardware.

4. Step-Level Documentation and Audit Trail

A compliant IVWMS documents:

• Products used

• Lot numbers and expiration dates

• Date and time of preparation

• Compounding technician

• Verifying pharmacist

• Alerts or overrides

Pestle records are:

• Time-stamped

• Locked after completion

• Searchable and reportable

This supports inspection-ready documentation.

Inventory and Dispense: Extending IVWMS Control

Beyond preparation, Pestle integrates:

Batch & Store Capabilities

You can:

• Produce batch preparations

• Store quantities in inventory

• Track waste and expirations

Patient-Specific Dispense

From stored inventory, you can:

• Dispense patient-specific doses

• Assign final labels

• Track which preparation was dispensed

• Return unused preparations to inventory (when appropriate and compliant)

This creates full traceability from:

Formulation → Preparation → Storage → Dispense → Documentation

Regulatory and Inspection Alignment

IVWMS implementation must align with:

• USP <795>,  USP <797>, USP <800>

• State board of pharmacy requirements

• Organizational SOPs

Pestle supports this by:

• Centralizing master formulation records

• Logging changes and version updates

• Supporting documentation of beyond-use dating

• Recording verification steps

• Generating reports for inspectors

If an inspector asks:

• “Who compounded this preparation?”

• “What lot number was used?”

• “What was the documented verification step?”

• “What was the beyond-use date?”

The record is accessible and defensible.

Operational Benefits for Pharmacy Teams

For Technicians

• Step-by-step structured workflow

• Reduced reliance on memory

• Clear documentation expectations

For Pharmacists

• Verification visibility

• Reduced transcription risk

• Logged override documentation

For Managers and Directors

• Centralized standardization

• Preparation-level reporting

• Exception tracking

• Inspection confidence

What Makes Pestle’s IVWMS Approach Practical

Pestle Formulas is designed for real-world compounding environments:

• Structured but not rigid

• Audit-ready without being burdensome

• Operationally focused

• Clear ownership at every step

It supports:

• Master formulation record control

• Ingredient documentation

• Inventory tracking

• Patient-specific dispensing

• Locked, time-stamped compliance record
  

What does IVWMS stand for?

Is IVWMS required?

Does Pestle replace gravimetric hardware?

Pestle supports documentation of volumetric verification processes and does not interface with gravimetric hardware. Hardware requirements depend on your facility’s configuration and SOPs. Pestle's web based Formulas solution can use any tablet or barcode scanner in or out of a clean room.