Pharmaceutical SOP Software

Last updated: 26 August 2026

Work error-free and comply with the strict laws and regulations in the pharmaceutical industry.

In the pharmaceutical industry, it is necessary to comply with laws and regulations in a traceable manner. Having good standard operating procedures is essential. With the Work Instruction App, you always have the current version of the standard operating procedure available on the work floor. The app offers you the possibility to register all activities so that you can demonstrate that you are in control.

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Quality in control

Comply with strict ISO-9001 and FDA regulations by being traceable in control.

Continuously improve

By having current work instructions directly available on the work floor, errors are quickly identified and the root cause can be resolved to prevent errors in the future.

Centralized workflow management

Centralized workflow management ensures that all employees have up-to-date instructions with the latest texts, images and videos. This means you are compliant at all times.

Support GxP Practices (GMP, GLP, GCP)

Standardize procedures across labs and manufacturing with clear, visual SOPs and checklists. Keep teams aligned on the latest steps, attachments, and references so execution is consistent and traceable.

Controlled updates: publish reviewed SOP versions to the floor.
Traceable execution: user, step, timestamp, and notes per run.
Evidence capture: photos and required confirmations at critical steps.

Quality outcomes

Fewer deviations and rework
Faster onboarding and retraining
Consistent execution across shifts

Change Control & Versioning

Manage updates centrally and release only approved instructions to the work floor. Keep a full history of edits so reviewers and auditors can reconstruct what changed and why.

Controlled updates

Update instructions centrally and publish the latest version to the floor. Previous versions remain in history for traceability.

Version history

Access prior versions and compare changes when needed.

Read & understand

Record that staff have seen updates before they execute work.

Audit Trail & Inspections

Generate an audit-ready trail of activities with user, timestamp, and SOP version. Export records quickly during inspections to demonstrate control and compliance.

Execution logs

Step-by-step results with notes, attachments and required checks.

One-click export

Share selected records and SOP versions with auditors on demand.

Lab & Production Use Cases

Equipment start-up & shutdown procedures
Cleaning & line clearance steps
Sampling and label checks

Deviations & temporary instructions
Calibration and maintenance checklists
Material receipt & status identification

Frequently Asked Questions about Pharmaceutical SOPs

The Work Instruction App supports GMP (Good Manufacturing Practice) compliance by enforcing controlled document workflows with version management, electronic approval, and read-and-understand confirmations. Every SOP change is tracked in a complete audit trail, ensuring your procedures meet the documentation requirements of GMP, GxP, and Annex 11 guidelines.

Digital SOPs can significantly reduce or replace paper batch records by capturing operator inputs, timestamps, and photo evidence electronically. The Work Instruction App provides a tamper-proof digital record of each production step, making batch review faster and eliminating the risk of illegible handwriting, missing signatures, or lost documents.

Data integrity is ensured through ALCOA+ principles: every record is attributable, legible, contemporaneous, original, and accurate. The Work Instruction App maintains a full audit trail of all changes, includes user authentication for each action, and provides exportable reports that satisfy FDA 21 CFR Part 11 and EMA data integrity expectations.