In pharmaceutical manufacturing, maintenance is a quality issue. Three problems make it more time-consuming than necessary.
Pharmaceutical industry
GMP-compliant digitalization of maintenance in the pharmaceutical industry
Every action must be documented, approved, and verifiable. SIMPL helps you reliably meet GMP requirements in maintenance.
Increasing demands, unchanged processes
Maintenance records are scattered across various paper documents; the search begins before the inspection
Maintenance, inspection, and calibration have their own schedules for each facility
Feedback is delayed, and approvals are difficult to track
Meet GMP requirements without mountains of paper
A digital foundation for every piece of equipment in the plant. Deadlines are met, and documentation is generated along the way.
Every action is documented with a timestamp and approval note and can be retrieved
Maintenance, inspection, and calibration deadlines for each piece of equipment are automatically marked as due
Feedback directly at the facility instead of days later at a desk
What SIMPL Can Actually Do in Pharmaceutical Manufacturing
From the equipment file to documentation that stands up to scrutiny by the auditor.
Equipment File
Every asset with a complete history throughout its lifecycle
A QR code on the equipment. Your maintenance technician scans it and sees the history, documents, and pending tasks—instead of flipping through a folder.
Equipment data, location, and criticality stored for each piece of equipment
Maintenance history, calibrations, and documents for the system
Traceable who carried out which measure and when
„Jetzt erfassen wir Kundenanfragen und Aufträge, inklusive aller relevanten Serviceberichte und Wartungsprotokolle, zentral in einer einzigen Lösung.“
Maintenance, Testing, and Calibration Schedules
Deadlines That Remind You Automatically
Maintenance, periodic inspections, and calibration have their own intervals for each system. SIMPL keeps track of them all.
Custom intervals for each system, including calibration schedules
Responsibilities and Checklists for Each Maintenance Schedule
Identifying Overdue Actions Early On
Audit Trail & Evidence
When the auditor arrives, everything will be ready
Every change is traceable, and every approval is time-stamped. No need to search through folders when an inspection is due.
Traceable record of who changed and approved what, and when
Actions stored with version control and easy to retrieve
Provide evidence for internal audits and regulatory inspections
Mobile Feedback
Documentation at the facility, with timestamps and approvals
Your maintenance technician will work through the checklist on the equipment and report back immediately, with a signature and approval note.
Checklist per asset type instead of a generic paper form
Measurements, photos, time stamp and approval note in a single process
Works offline, even in areas without reception
Analysis & Metrics
See where problems tend to occur
Which systems are experiencing repeated outages? Which deadlines are approaching? Documentation becomes operational insight.
Make recurring faults visible per asset
Identify overdue actions early
Metrics for quality management and plant management
Why SIMPL in Pharmaceutical Manufacturing
A structure suited to regulated environments
Your processes must remain traceable. SIMPL is quick to implement and ensures that every action is easy to find.
Personal support that understands regulated production
Role-based permissions and traceable changes
Made and hosted in Germany, designed to meet strict compliance requirements
„Früher musstest du alles manuell durchgehen – jetzt geht alles deutlich einfacher. SIMPL nimmt uns so viel Arbeit ab."
Get Your Maintenance Ready for Inspection
Try SIMPL and consolidate deadlines, feedback, and documentation into a single system.
A no-obligation consultation with our experts
Specifically, using your equipment and maintenance schedules as an example
Personal Contact
No preparation needed—just bring your questions
Frequently Asked Questions: Maintenance Software in the Pharmaceutical Industry
What are the benefits of maintenance software in pharmaceutical production?
SIMPL consolidates maintenance history, deadlines, checklists, and feedback for each piece of equipment in one place. Upcoming tasks are automatically flagged, documentation is created directly at the equipment site, and the records are easily accessible when quality management or inspectors request them.
How do I manage maintenance, inspection and calibration deadlines per asset?
Each piece of equipment is assigned its own schedule, including recurring inspections and calibrations, along with responsibilities and checklists. Overdue tasks become visible early on, rather than only being noticed during the next review of the deadline list.
How are feedback and approvals documented in a traceable way?
The maintenance technician works through the checklist on the equipment and reports back immediately, including measurement values, photos, timestamps, a signature, and an approval note. This makes it possible to track who performed and approved which action and when.
How does the GMP validation of SIMPL work at our site?
It is not the software itself that is validated, but rather your specific use of it. You define what the system is supposed to do, assess the risks, and demonstrate during the qualification process that it is correctly installed and functions as intended. The end result is your validation report. The advantage: SIMPL is configurable off-the-shelf software and therefore falls under GAMP 5 Category 4. The effort required is based on the risk and is significantly lower than that of an in-house development. We provide the documentation for your supplier qualification and guide you through the qualification process. Contact us, and we’ll walk you through the process together.
How does SIMPL help when an auditor or inspector comes?
Every action is logged with a timestamp, the person responsible, and an approval note, and can be easily retrieved with version control. Instead of gathering documents from folders, you can view the current status for each piece of equipment directly. This takes the pressure off the preparation process and makes it clear—even between inspections—what still needs to be addressed.
Can SIMPL be integrated with our ERP or MES?
Yes. Your ERP system will continue to be the primary system for master data and procurement, while SIMPL will handle the operational maintenance level and can be integrated with it. It’s also possible to get started with an Excel import if you want to run a pilot in a specific area first.
Intuitive operation that works right away
SIMPL is designed so that technicians, service managers, and workshop teams can start working with it right away—without lengthy training and without feeling overwhelmed.
Offline Capability for Your Technicians
Technicians can enter jobs, forms, and photos entirely offline—everything syncs automatically as soon as a network connection is available again.
Made & Hosted in Germany
Your data is stored in certified German data centers. Perfect for mechanical engineering firms and industrial companies with strict compliance requirements.
