For Pharma & Life Sciences Plants

The CMMS Built for Pharma & Life Sciences Plants

An AI-first CMMS for pharmaceutical, biotech and medical device manufacturers, built around your cleanrooms, autoclaves, lyophilizers, isolators and filling lines, with IQ/OQ/PQ and 21 CFR Part 11 records baked in.
Industry leaders we work with
What Changes When You Switch

Equipment qualified. Records signed. One source of truth.

The four outcomes every plant wants — delivered with the cleanroom, qualification and recordkeeping specifics pharma and life sciences manufacturers actually need.

Reduce Unplanned Downtime

Fewer unplanned stops on filling lines, isolators, autoclaves, Iyophilizers and HVAC. Faster mean-time-to-repair when equipment does go down.

MTBF • MTTR
Stay in a Qualified State

Calibration, requalification, environmental monitoring and PMs scheduled to keep IQ/OQ/PQ status current — not in a 2 a.m. Rebuild before an inspection.

IQ/OQ/PQ • Calibration
Records Auditor Can Read

Digital work-order history, e-signatures, photo evidence and sanitation logs — exportable for FDA / USDA inspections and your internal HACCP, SQF or BRCGS programs.

21 CFR Part 11 • Audit Trail
Spreadsheets & Paper Logs

Every work order, PM, calibration, requalification and deviation in one place. Not a shared drive, not a clipboard, not a paper logbook in the gowning room.

One Source of Truth

Pharmaceutical CMMS

Looking to streamline maintenance across pharmaceutical and life sciences facilities? Makula is a CMMS for pharmaceutical manufacturers and GMP plants, built to help cleanrooms, autoclaves, isolators and filling lines manage work orders, preventive maintenance, calibration and assets across sites. You get the CMMS features pharmacy and plant maintenance teams need: less unplanned downtime, higher OEE, and an audit trail that's ready for FDA, EMA and MHRA inspections, without spreadsheets, shared drives or paper logs.

AI Copilot for Pharma

An Al That Knows Your Suites, Qualifications And History.

Makula Al Copilot learns from your own work-order history, asset registry, calibration records and SOPs. Ask a question in plain language and get cited answers — grounded in your data, not the public internet.
Inspection-prep in minutes — Show every PM, calibration and requalification on Filling Line 2 last quarter” returns linked evidence, ready to export for an FDA or EMA inspector
Deviation-pattern detection — the Copilot spots recurring issues (HEPADP drift, isolator glove integrity, autoclave cycle deviations) before they become CAPA findings
Private & secure — your plant data is never used to train third-party models. Every answer is cited. Hosted on ISO 27001 certified infrastructure.
Built To Support Your GMP Program

Designed Around the Records Pharma Auditors and Inspectors Ask For.

Makula isn't certified to GMP — that's a plant-level certification. We provide the validated digital work-order, calibration, requalification and e-signature records your quality team uses to maintain its program.
Supports GMP / GxP
Supports 21 CFR Part 11
Supports EU Annex 11
Supports IQ/OQ/PQ
Supports PIC/S
FDA / EMA Recordkeeping
21 CFR Part 11 e-sigs
Tamper-evident Audit Trail

Makula Itself, Certified.

GMP frameworks certify the plant. Software security frameworks certify Makula. Here's where we stand today, and what's on our roadmap.

Certified
ISO  27001

Information security management. Independently audited annually. Covers data security, access controls, encryption and incident response.

Independently audited annually by TÜV Nord
Compliant
GDPR

EU data-protection compliance for personal data of technicians, operators and contractors stored in Makula.

On Request
21 CFR Part 11

Electronic records & e-signature validation for FDA-regulated environments (pharma, dietary | supplements, infant formula). Validation package available for qualifying customers.

Hosted on EU Data Centers (Germany) Encryption in transit (TLS 1.2+) and at rest (AES-256) - Role-based access -
Full audit log - No customer data used to train third-party Al models.
What Teams Typically See

"Maintenance teams using Makula tell us the same thing — they go from chasing breakdowns to actually preventing them, and inspection prep stops being a three-week scramble.”

What We’ll Measure With You
Downtime
Fewer unplanned stops on filling lines, isolators, autoclaves and HVAC
PM on Time
More preventive, calibration and requalification work completed on schedule
Inspection Prep
FDA / EMA inspection prep stops being a multi-week scramble across QA, maintenance and validation
Go-Live
Single-plant deployment is measured in weeks, not quarters
What Changes When You Switch

Three Numbers Pharma Teams Actually Move

Generic CMMS tools chase dozens of metrics. We focus on the three that matter inside a GMP plant.

MTBF

Mean Time Between Failures — the headline reliability number for fillers, conveyors, mixers and refrigeration units

MTTR

Mean Time To Repair — how fast your team
gets a line back online and running when something does fail

PM
On Time

Preventive maintenance and sanitation completion rate — the leading indicator that keeps the first two numbers moving in the right direction

Other Verticals We Serve

Not a Pharma Plant? Makula Is Also Built for These Plants

Packaging

Converters and co-packers

Learn more
Chemical

OSHA PSM • EPA RMP

Learn more
Industrial

Discrete manufacturing

Learn more
Food & Beverages

Bottling, fillers, refrigeration

Learn more

Frequently Asked Questions

Is Makula a CMMS for pharmaceutical manufacturers specifically?
Yes. Built for pharmaceutical, biotech and medical device plants, designed around cleanrooms, autoclaves, lyophilizers, isolators, filling lines and HVAC, with native support for IQ/OQ/PQ and 21 CFR Part 11.
Does Makula replace separate calibration software?
For most pharma teams, yes. Makula functions as CMMS calibration software alongside preventive maintenance, gauges, sensors and instruments stay on their due dates with certificates attached, in the same system as your work orders and audit trail.
How long does validation take?
We provide an IQ/OQ validation package on request for qualifying customers. Most teams complete user-side validation in weeks. Makula is a configured product, not a custom build.
Where is our data hosted?
EU data centres in Germany. TLS 1.2+ in transit, AES-256 at rest, ISO 27001 certified infrastructure. Your plant data is never used to train third-party AI models.
How does Makula handle change control?
Configuration changes that affect validated workflows are tracked with versioning and e-signed approval, the change control evidence your quality team needs without a parallel spreadsheet. Complements (not replaces) formal change control software for life sciences when one is in place.

Ready to Keep Your Plant in a Qualified State?

Here’s what our customers say about us

Since implementing Makula in June 2023, we've seen a dramatic reduction in errors and a significant boost to our after-sales efficiency. Makula has streamlined our processes, allowing us to provide faster and more accurate service to our customers. This has not only improved customer satisfaction but has also generated additional revenue through monthly sales.

Robert Thornton
Sales Director

The efficiency and clarity that Makula brought to our after-sales operation is unparalleled. Our team is more aligned, our customers are happier, and our revenue is on the rise. Highly recommended!

Norbert Kaiser
Managing Director

The overview of all the latest offers, spare part orders, invoices, and service reports, helps the customer enormously. The software has really developed very well and Makula is doing a great job. The service is great, if I need something, there is always an answer from Karina very quickly.

Michael G.
Chief Executive Officer

We have had a great experience with the Makula team from the sales process to onboarding and then helping with day to day support if needed. The team are always quick to come back to us and provide solutions to requests. The platform is easy to access and navigate and Makula have already incorporated most of the functionality we need. This enables us to support our customers with the tools and resources they need to order spares, access machine information or book service visits.

Lizzie W.
Marketing Executive

The software is very user-friendly and intuitive to use. The team assists very intensively with the transformation process and onboarding. We have managed to integrate the tool into our daily processes, thereby promoting our internal coordination and ultimately our spare parts sales.

Flynn S.
Advisory Board Member

Thanks to the implementation of Makula, we have achieved full traceability of all customer requests. We consolidated all after-sales interactions into a single platform, which has significantly improved our response times and operational efficiency

Fernando Neves
Global Customer Support Manager

Since we started using Makula, we've gained a broader perspective on the evolving world of digital after-sales. The software has seamlessly blended with our processes, enhancing operations and providing fresh insights. It's a gentle reminder of the portential avenues open for SME machine suppliers in this digital era.

Erik Döinghaus
Managing Director

Makula's platform has been a game-changer for us. Onboarding was incredibly smooth, and the system's ease of use has significantly improved our after-sales service efficiency. Our technicians now save several hours each day by reducing the time spent on phone calls and searching through scattered documents.

Edward Herbert
COO & Founder

Being a user of 30+ machine brands, I can firmly state that Makula's after-sales platform is transformative. It doesn't just enhance and streamline communication with OEMs—it revolutionises it, driving unparalleled customer satisfaction in an increasingly complex and dynamic production

Christopher Staub
Chief Executive Officer