Skip to content
Work Instruction App Work Instruction App
ENNLDE
Free trial
Free trial

Pharmaceutical SOP Software

Last updated:

In short

SOP software for pharmaceuticals manages GMP procedures as controlled, versioned documents and records every execution with user, timestamp and entered values. Operators always work from the approved version, required steps cannot be skipped, and the run history supports batch documentation, deviations and audits under EU GMP.

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.

Start your free 30-day trial

What it looks like in the app

List of completed runs with date, user and status
Completed runs: who did what and when, ready for an audit.
A work instruction step on a phone: safety checks, order number and machine
On the shop floor: large buttons and fields on a phone or tablet.
Details of a completed run: start and end time, duration, user and the recorded values

Quality in control

Work traceably and in control, as ISO 9001 and GMP expect: every run is recorded with user, time and version, and deviations are flagged on the run.

Details of a work instruction: versions, runs and history

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.

Work Instruction App overview: runs that are not finished, open tasks and the runs to continue

Centralized workflow management

Centralized workflow management ensures that all employees have up-to-date instructions with the latest texts, images and videos, so nobody works from an outdated copy.

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

Older versions stay in the history, and a review shows which steps were added, removed or changed compared with the published version.

Four-eyes review

With Review required, a colleague with Manage who did not author the version approves it with their own password before it is published.

Audit Trail & Inspections

Every run is recorded with user, timestamp and SOP version, and every change to an instruction is kept in its history. Export runs to Excel or CSV or print a run as PDF during an inspection.

Execution logs

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

Export and print

Runs per work instruction and period to Excel or CSV, and a print page per run that you save as PDF.

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 working practices with versioned procedures, an optional review of every new version by a second person, approval of runs by a second signer who confirms with their own password, and a history of every change to an instruction. Validation of the app as a computerised system under EU GMP Annex 11 remains part of your own quality system.

Digital SOPs can reduce paper batch records by capturing operator inputs, timestamps and photo evidence electronically. A completed run is final and can no longer be changed in the app, values outside their limits are flagged, and a second signer can approve the run. That makes batch review faster and removes illegible handwriting and lost sheets.

The app supports the ALCOA+ principles: every record is attributable to a personal account, contemporaneous (saved with server time), original and kept after completion. Changes to instructions and the start, completion and approval of runs are kept in an append-only history, and runs can be exported. We do not claim compliance with FDA 21 CFR Part 11; how the app fits your data integrity requirements is part of your own validation.

Yes. Switch on Approval required for the work instruction. A completed run then waits until a Manage user who did not perform it approves it with their own password, or rejects it with a reason, which sends it back to the performer. Approver, time and status appear in the run details, the export and on the print page. Users who only sign in with single sign-on cannot approve, because they have no app password.

Limits are part of the instruction: a number outside its minimum or maximum or a barcode that is not the expected one blocks Next and Finish until it is corrected, and answers such as No can be marked as a deviation. The server judges every saved run against its version; a run with a deviation gets a label, a filter and a Deviations section at the top of the run details. Investigating the deviation stays in your quality system.
Start your free 30-day trial

Sources

Related pages

Start your free 30-day trial · no credit card