

SOP-Guard
The Efficiency Booster
SOP-Guard Document Management
Unleash the full potential of your administrative tasks in quality management and optimize your workflows with the innovative support of SOP-Guard. Regardless of your industry, SOP-Guard allows you to effortlessly create, review, approve, distribute, and archive documents. Our success-oriented document training feature provides you with user-based control over your electronic document management for GxP systems. By using SOP-Guard, the path is paved for a future of efficiency, productivity, and success.



Top 5 Advantages
- Validated software for 100% electronic management of documents in regulated companies
- Accurate monitoring of deadlines including timely corrective measures.
- Correct representation of responsibilities and accountabilities.
- Automated assignment of documents to the appropriate user group.
- Automation of previously manual steps in document management.
SOP-Guard is validated according to GAMP 5, GxP, and FDA compliant.
Customer Testimonials
Der geringe Aufwand bei Erstellung, Prüfung, Genehmigung, Verwaltung und Schulung der unterschiedlichsten Vorgabedokumente sowie die Flexibilität von SOP-Guard waren klare Pluspunkte.
Dr. Martina MaritzHead Corporate Quality Assurance Develco Pharma GmbH
A DMS can cover three quarters of our requirements, but the spice lies in the remaining 25 percent that SOP-Guard offers.
Ivica SaricLeiter IT | Validierungskoordinator ITUrsapharm Arzneimittel GmbH
SOP-Guard is easy to use and quick to understand. This significantly simplified the roll-out in six Eastern European countries.
Mag.pharm. Georg E. SchmidtHead of Pharmaceutical AffairsChiesi Pharmaceuticals GmbH
SOP Guard makes life significantly easier for us in a smaller academic GMP facility. Easy to use, logical structure, prompt customer service, and well-prepared documents for the validation and revalidation of the system make it a very helpful program for efficient and GMP-compliant document control.
Dr. Daniela WehlerSachkundige PersonIII. Med. Klinik und Poliklinik, Universitätsmedizin Mainz
Top software! Top product! Top service! Satisfied customer since 2016. SOP-Guard is an indispensable part of our GMP compliance.
The team at Aiti GmbH provides immediate support for all issues and consistently develops the software further!
Johannes SchäferStv. Leiter der QualitätssicherungPaul W. Beyvers GmbH
Quick-Facts
SOP-Guard was specifically developed for GxP environments and offers a central platform for easy management and control of important documents. The specialized and powerful program features, combined with an intuitive user interface, enable a reduction in errors and time loss. SOP-Guard is fully compliant with current regulatory requirements, thereby providing improved efficiency, increased security, and better document control.
SOP-Guard optimizes manual, time-consuming document processes and ensures smooth structuring. Our system enables efficient document management with fast data retrieval, saving valuable time resources. We guarantee rapid and productive implementation, short training periods, and a flat learning curve.
We place great importance on the feedback of our users and customers, which is actively integrated into the development of our software. Our solution has received numerous positive reviews and has successfully passed audits and inspections. Let us help you improve your document management processes for the success of your company.
Our software solution offers installation at a location of your choice (on-premises, private cloud, etc.) ensuring that both the software and data storage take place within your company’s network. Developed with web technology, our software is compatible with common devices such as PCs, laptops, and tablets. The software is delivered to you as a validated virtual machine, and our maintenance contract strictly defines our responsibilities and clarifies the respective roles. Additionally, we offer numerous interfaces that enable seamless connectivity with existing systems (e.g., Active Directory via LDAP).
– SOP-Guard is fully validated as a product according to GAMP 5 (Category 3).
– The software complies with the requirements of, among others, the following regulations: GxP (EU), ICH, and 21 CFR Part 11.
– Traceability through an internal audit trail for detailed recording of actions within the system
– Extensive validation packages (installation documentation, test case documents, risk analysis …)
SOP-Guard schnell erklärt
Downloads
SOP-Guard
| Title | Categories | Download |
|---|---|---|
|
SOP Guard: Vorteile auf einen Blick | Softwarelösungen, SOP-Guard | Download |







