Traceability & Audit Trail Software
Traceability in Production 4.0
The entire production at a glance
Industry and trade are increasingly demanding greater transparency in production and a supply chain that is fully comprehensible. Especially in the automotive and pharmaceutical industries, production processes need to be monitored closely in order to clearly track interventions and changes. But traceability can also help to produce more effectively and in a more optimized manner. Last but not least, traceability or audit trail software ensures greater connectivity and data availability – and paves the way towards Industry 4.0 in your company
What are Traceability & Audit Trail: Definitions of Terms
Traceability is a combination of the English words “trace” and “ability” – it literally means the ability to follow a trace.
In simple terms, traceability in production or the supply chain describes the relationships between artifacts in the development process. It is intended to ensure that critical requirements have been implemented in an appropriate form.
The Audit Trail is a quality assurance tool that ultimately enables traceability. However, Audit Trail is primarily used in a regulated environment, as interventions in the supply and value chains must be comprehensible, controllable, and fully visible.
These are legal requirements that play a major role in the pharmaceutical, food, and automotive industries, for example.
Why do I need traceability or audit trail software?
In both cases, the aim is to make the locations and processes of the entire production and value chain traceable. On the one hand, the geographical aspect is important: it must be possible to see where raw materials or service providers come from.
On the other hand, the processes in production must also be traceable and it must be made clear which steps the product has gone through.
Traceability software primarily aims to make flows of goods visible in order to exploit the economic added value. The knowledge gained from increased transparency is helpful for optimized production control and higher efficiency. Among other things, traceability can be used for “track and trace” use cases; this is important in the tobacco industry, for example.
If traceability is legally required in your own production as part of requirements management, the Audit Trail software is used. The focus here is on meeting requirements in the regulated environment and ensuring traceability and security – or even avoiding penalties.
Traceable to the smallest detail!
- Audit trail can be the basis for guaranteeing the authenticity of products, thus reducing counterfeiting and smuggling.
- In the case of good manufacturing practice requirements, for example in food production and pharmaceutical production, producers must ensure traceability, since the health of consumers is at stake.
- Another aspect is ethically correct production. The Audit Trail software ensures authenticity, origin, or freedom from child labor.
Technical Challenges
on the way to digital traceability in your own Smart Factory
The challenges for companies that want to implement traceability software or legally have to use audit trail software lie to a large extent in digitization. An additional difficulty is that some suppliers bring a very poor level of digitization. In order to map the entire value chain with the audit trail or traceability software, digital retrofitting must take place at all levels
A digital data architecture is also a prerequisite for digital traceability. You have to create a basic technical framework of production to implement this use case. This requires the right technology, an integration platform, and also expert knowledge. All of this is provided by soffico.
Requirements for manufacturing companies: When Traceability & Audit Trail become a Requirement
So far, only about 33% of German SMEs use traceability systems. Because: 60% of German
companies see integrability as the biggest obstacle. But what if transparency in production is required by law?
Many companies now have legal requirements for production that make traceability or audit trail software indispensable:
Documentation and archiving obligation
Reliable documentation must / should be automated
It is often already difficult to fulfill all requirements within the country. It is even more difficult outside national or organizational borders.
Government tasks such as monitoring companies and ensuring compliance with regulations are increasingly being shifted to private companies. This causes costs that can be kept low through traceability / audit trails.
What our customers say
For me, Orchestra is the solution to simplify the integration of equipment into the pharmaceutical store floor and to integrate it in a modular and sustainable way.
Implement Traceability & Audit Trail with soffico
We help your production to implement digital quality assurance with the help of our industrial software, which creates the necessary connectivity for both traceability software and audit trail software requirements and provides data reliably.
Implementation of Traceability Software
We can assign all data to the product and finally create connectivity even in classic production. We transfer all necessary data to the customer or the certification body – all this in automated processes.
Implementation of the Audit Trail Software
We can already offer this option as a product feature. Especially the topic GMP (Good Manufacturing Practice) we cover with Orchestra and also have trained experts in the team, who take care of the concerns and needs of pharmaceutical companies, food manufacturers and Co.
The data availability gained
through our Orchestra middleware is best used in your production for further IoT use cases, such as IT/OT convergence or MES integration.
Advantages of digital quality assurance with Orchestra Industrial Suite
The Industrial Suite Low Code Platform takes care of compliance for your production using traceability or audit trail. This practical outsourcing not only increases efficiency within your own company, but also reduces costs.
Despite the increased transparency along the production and value chain, we reliably protect sensitive data from unauthorized access through special encryption mechanisms.
Choose reliable software – and a reliable partner for your business. The software from soffico offers you and your production a number of additional benefits:
Future proofing
Data security
Transparency & data sovereignty
Investment protection
Stability & Reliability
Edge-Architecture
Sarah Blomeier
