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 pieces of paper; the search begins before the inspection
Maintenance, inspection, and calibration have their own schedules for each system
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 approaching, and documentation is generated automatically.
Every action is documented with a timestamp and approval note and can be retrieved
Maintenance, inspection, and calibration deadlines for each system 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 piece of equipment with a complete history spanning its entire 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
It is clear who carried out which action and when
„We now track customer inquiries and orders, including all relevant service reports and maintenance logs—centrally in a single solution.“
Maintenance, Testing, and Calibration Schedules
Deadlines That Notify 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 is ready
Every change traceable, every approval time-stamped. No searching through folders when the 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 on site, with time stamp and approval
Your maintenance technician works through the checklist on site and reports back directly, with 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 faults are piling up
Which assets fail repeatedly, which deadlines are slipping away. Documentation becomes management insight.
Make recurring faults visible per asset
Identify overdue actions early
Metrics for quality management and plant management
Why SIMPL in pharmaceutical production
Structure that fits regulated environments
Your processes need to stay traceable. SIMPL is quick to roll out and keeps every action easy to find.
Personal support that understands regulated production
Role-based permissions and traceable changes
Made & hosted in Germany, for high compliance requirements
„In the past you had to go through everything manually – now everything is much easier. SIMPL takes so much work off our hands."
Make your maintenance inspection-ready
Try SIMPL and bring deadlines, feedback and evidence into one system.
Non-binding call with our experts
Concretely, using the example of your assets and maintenance plans
Personal contact person
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?
For each asset, SIMPL brings together maintenance history, deadlines, checklists and feedback in one place. Due actions come up automatically, documentation is created directly on site, and the records are easy to find when quality management or an inspection asks for them.
How do I manage maintenance, inspection and calibration deadlines per asset?
Each asset gets its own intervals, including recurring inspections and calibrations, with responsibilities and checklists. Overdue actions become visible early, instead of only coming to light at 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 site and reports back directly, with measurements, photos, time stamp, signature and approval note. This makes it traceable who carried out 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 your specific use of it. You define what the system is supposed to do, assess the risks, and demonstrate during qualification that it is installed correctly and works as intended. The result is your validation report. The advantage: SIMPL is configurable off-the-shelf software and therefore falls into GAMP 5 category 4. There, the effort depends on the risk and is significantly lower than for an in-house development. We provide the documents for your supplier qualification and support you through the qualification. Get in touch and we will go through the process together.
How does SIMPL help when an auditor or inspector comes?
Every action is stored with a time stamp, responsible person and approval note, and remains findable with version control. Instead of gathering documents from folders, you call up the status per asset directly. This takes the pressure out of preparation and also makes it visible between inspections where something is still open.
Can SIMPL be integrated with our ERP or MES?
Yes. Your ERP remains the leading system for master data and procurement, SIMPL becomes the operational maintenance layer and can be integrated. Starting via Excel import is also possible if you first want to pilot one area.
Intuitive operation that works right away
SIMPL is built so that technicians, service managers and workshop teams can start working with it right away – without lengthy training and without being overwhelmed.
Offline capability for your technicians
Technicians can capture orders, forms and photos completely offline – everything is synchronised automatically as soon as a connection is available again.
Made & Hosted in Germany
Your data is stored in certified German data centres. Perfect for machine builders and industrial companies with high compliance requirements.
