Implement GMP-Compliant SOPs with the Work Instruction App
Last updated:
Operating in a regulated environment? Whether you're in pharmaceuticals, medical devices, or food production, GMP-compliant Standard Operating Procedures (SOPs) are essential for ensuring quality, traceability, and audit readiness.
The Work Instruction App makes it easy to create, maintain, and distribute SOPs that meet Good Manufacturing Practice (GMP) requirements — with full version control, audit trails, and mobile accessibility.
Ensure GMP Compliance with Digital SOPs
Audit-Ready Documentation
Maintain a complete history of SOP updates, approvals, and revisions — with timestamps and user credentials.
Ensure Compliance
Follow GMP guidelines by enforcing version control, approvals, and digital signatures for every SOP.
Real-Time Updates
Operators always access the most up-to-date version of each SOP — reducing deviations and risks.
Role-Based Access
Control who can view, edit, or approve SOPs.
What Makes an SOP GMP-Compliant?
GMP-compliant SOPs must be clear, validated, version-controlled, and traceable. They need to reflect actual practices on the floor, be regularly reviewed, and include documented approvals.
The Work Instruction App simplifies this by offering features designed specifically for regulated industries:
- Document control with approval workflows
- Electronic signatures and validation logs
- Time-stamped audit trails
- Automatic distribution of new versions
- Read & understand confirmations
Whether you're preparing for an FDA inspection or meeting ISO standards, our app supports full GxP compliance.
Industries That Rely on GMP SOPs
SOPs under GMP are critical in regulated sectors where quality, safety, and repeatability must be guaranteed. Our digital SOP system is ideal for:
- Pharmaceutical manufacturing
- Medical device production
- Food and beverage processing
- Cosmetics and personal care
- Biotechnology and laboratory operations
All procedures are stored centrally, with strict access control and instant availability on mobile or desktop — helping you stay inspection-ready at all times.
Digitize and Control Your GMP SOPs Today
Try the Work Instruction App free for 30 days and simplify GMP compliance with controlled, validated digital SOPs. No credit card required.
What GMP requires from work instructions
Good Manufacturing Practice (EU GMP, FDA 21 CFR 210/211, and GMP+ for feed) requires that production and quality-control operations follow approved written procedures, that deviations are recorded and investigated, and that records are contemporaneous, attributable, legible, original and accurate (ALCOA). Paper SOPs can satisfy this, but only with strict discipline around versions, signatures and record retention.
The Work Instruction App turns these requirements into properties of the system: only the published version can be executed, every step is recorded with user and timestamp at the moment it happens, and completed executions keep their original values. Training and qualification are visible in the skills matrix.
How GMP work instructions work in the app
- Draft, review and publish a procedure; only the published version is visible to operators (see version control).
- Operators execute step by step and record values, checks and photos as they go, with the target value shown in the step.
- Deviations are recorded as a remark or a photo in the step and are visible to QA in the execution overview.
- Records are complete and retrievable per batch, instruction, user or period for inspections and batch release (see audit trail).
Use case: line clearance before a packaging run
Before a new packaging batch starts, the line must be cleared of materials from the previous product and checked against the packaging order. A digital line-clearance instruction walks the operator through each zone with a reference photo, asks for a confirmation and a photo of the cleared zone and a scan of the new packaging material. The QA release is a signature step at the end.
The inspector no longer relies on a ticked checklist; the photos and timestamps show that the clearance was actually performed, in the right order, by a qualified person.
Frequently asked questions about GMP and digital SOPs
The app supports GMP working practices: versioned procedures, attributable records and executions that keep their original values. Validation of computerised systems (GAMP 5, EU GMP Annex 11) is the responsibility of the user; we supply documentation and support to help you with it.
Yes. Every execution can be opened in the app with all values, photos, users and timestamps per step, and retrieved through the REST API for your own reports.
A signature step captures a signature with user and timestamp. Whether this meets 21 CFR Part 11 requirements depends on your procedures for user identification and controls; contact us to discuss your case.