Our software solution for your document & quality management
Modular. Holistic. Effective.
Your path to digitalization
Our digitalization solutions primarily address document-based processes in manufacturing, production and quality management.
The basis of the d.3 life sciences system is a holistic ECM/DMS system. All software solutions can be introduced as modular building blocks and can be expanded like a building block model to a complete GxP-compliant eQMS suite. The building blocks highlighted in blue illustrate this aspect.
The ECM/DMS system can also be extended to include non-GxP applications and can be linked to your existing ERP system (e.g. SAP), thus enabling you to implement almost all document-based processes in your company.
Get a compact short overview
Document Control
Whether work / process instructions (SOPs), process descriptions, test specifications or other types of documents — you can create, revise and sign them all digitally with this module.
Training Management
Extend the “Document Control” module to actively plan and record the qualifications of your employees with our training management.
E‑learning
Use the new module “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
Document Control
Whether work / process instructions (SOPs), process descriptions, test specifications or other types of documents — you can create, revise and sign them all digitally with this module.
Training Management
Extend the “Document Control” module to actively plan and record the qualifications of your employees with our training management.
E‑learning
Use the new module “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
QM Workflows (Complaint | DC | CAPA | CC)
Digitalize your ISO processes. Control your production-related QM processes using digital workflows.
QM Workflows (Complaint | DC | CAPA | CC)
Digitalize your ISO processes. Control your production-related QM processes using digital workflows.
Technical Documentation
Create and update your technical documentation, e.g. in accordance with the requirements of the Medical Device Regulation (MDR).
Contract Management
Keep track of your contracts. Let us remind you about key dates such as termination options or renewal options in a multi-stage procedure.
Technical Documentation
Create and update your technical documentation, e.g. in accordance with the requirements of the Medical Device Regulation (MDR).
Contract Management
Keep track of your contracts. Let us remind you about key dates such as termination options or renewal options in a multi-stage procedure.
Frequently asked questions (FAQ’s) about the quality management system
What are the specific requirements that GxP places on quality management?
As an answer, the German GMP regulations, AMWHV, help us: The quality management system (QM system) is a system that includes quality assurance, good manufacturing practice or good work practice, including quality control and periodic product quality review (PQR) (§ 2 Definitions).
§3 Quality management system, good manufacturing practice and good professional practice
Companies and facilities must implement a company quality management system (QM system) that corresponds to the type and scope of the activities performed. The QM system shall include good manufacturing practice in the cases referred to in paragraph 2 and good professional practice in the cases referred to in paragraph 3, and shall provide for the active participation of the management of the establishments and facilities and of the personnel of the various sectors concerned. All areas involved in establishing, maintaining and implementing the quality management system must have competent personnel and suitable and sufficient premises and equipment. The quality management system must be fully documented and its proper functioning demonstrated (§ 1).
For which industries does the introduction of a quality management system make sense?
Certified companies have long been the norm in manufacturing and industries with many production steps. However, it is also a fact that it’s increasingly used in the service sector. Managers have understood that process and “product” quality are also methods in this area to differentiate their own product from that of the competition. Furthermore, process quality is an effective way to avoid the cost of errors. That is why more and more companies in the service sector are relying on the DIN EN ISO 9001 quality management standard. The more specific the industry, the more specific the standard. For example, laboratories have an ISO 17025 system, the automotive industry has the IATF 16949 standard, and medical device manufacturers have the ISO 13485 standard. These exemplary standards are all derived from ISO 9001. However, due to their respective fields, they often have more extensive requirements and more specific bases.
What are the benefits of a quality management system?
A quality management system (QMS) has many advantages. It can lead to cost savings and facilitate market access. A quality management system helps companies in the following essential aspects:
- Improved market access: In a globalized market environment, a company with a certified QMS can demonstrate that quality and process safety are systematically addressed. In some industries, such as the automotive industry, such a certificate is a mandatory requirement for business transactions.
- Better quality at lower cost: Quality management ensures quality as early as possible in the development process. Early detection of defects is much more cost effective compared to detection during final inspection.
- Cost savings: The company saves money by producing less waste. This reduces the cost of purchasing raw materials and disposing of waste.
- Systematic quality thinking among employees: A QMS allows all employees of a company (not only the quality assurance experts) to be involved in quality assurance.
- Transparent business processes: Operational processes are documented and described. This makes them transparent and easier to review for improvement opportunities. It also makes it easier to identify and eliminate problems.
- Sustainable standard: Quality management systems help to secure the achieved optimizations in the long term by making the improved procedures and processes “standard practice” and thus the norm.
- Better know-how transfer: Documented and described workflows and processes enable a more efficient and effective transfer of operational know-how. This makes it easier to train new employees, for example.
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