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Debra Garls

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Optimisation of document-based processes in a regulated environment

Document control and conversion, document output for SAP and label printing in SAP

Optimisation of document-based processes in a regulated environment
Pharma-Englisch-2-260x300 Regulated EnvironmentCompanies in a regulated environment must observe very special regulations. For example, when it comes to document-based business processes.

One such company from the regulated environment is ACME Pharmaceuticals. The listed pharmaceutical group specializes in the manufacture of prescription drugs, generics, and medical devices. Around 12,000 people are employed there. Headquartered in Los Angeles, the company also has four other production sites located in Germany and abroad.

Pharma-Englisch-4-300x242 Regulated EnvironmentPharmaceuticals repeatedly encounters problems with documents in the SAP system. For example, tracking documents in the SAP DMS has proven to be extremely difficult. Or if approval processes go wrong and unreleased documents end up in production. Currently, ACME Pharmaceuticals is doing this process manually, which ultimately wastes time, money, and resources.

When it comes to finding the right documents in SAP, employees often become extremely frustrated. Finding correct documents and drawings in SAP DMS is an error-prone process and involves a great deal of manual work.

Last but not least, the quality of the printed labels also causes problems from time to time. The labels cannot be traced, the statusPharma-Englisch-1-300x288 Regulated Environmentof the label is not recognizable, and there is no versioning.

But this is about to change. ACME Pharmaceuticals has hired a new employee: Dr. Peter Smith, SAP expert, who will now be responsible for solving problems surrounding document-based processes. In the following White Paper, accompany Dr. Peter Smith during the analysis of the initial situation, discussions with his colleagues, and overcoming of the challenges. As you might suspect: SEAL Systems plays a significant role in this…

Title-white-paper-optimized-processes Regulated EnvironmentIn this white paper you will learn how companies in the regulated environment solve the following challenges:

Document control and conversion

Challenge: Release and traceability in production
The solution: Automatic application of a release stamp, any data from SAP and further control information (e.g. who printed the document and when?)

Document output for SAP

Challenge: Finding the right documents in purchase and production
The solution: Installation of a document deterination solution in SAP that collects the corresponding documents for the respective SAP objects

Label printing for SAP

Challenge: The quality of the printed labels
The solution: Installation of a label creation tool in which the labels are designed and prepared. The design of the labels is fully customizable, and any data from SAP can be used


Icon-PDF-43x58 Regulated EnvironmentRequest our free white paper about the optimisation of document-based processes in a regulated environment now!*

*No newsletter, no forwarding, contact by email only for the purpose mentioned.

Pharma-Englisch-3-166x300 Regulated EnvironmentDocument-related processes as a challenge in the company

Companies from the regulated environment often have problems with documents in the SAP system. This is the case, for example, when documents need to be tracked in the SAP DMS, but this cannot be done automatically, only manually. Or when release processes go wrong and documents that have not been released end up in production. Similarly, finding the right documents often presents such companies with challenges. Finding correct documents and drawings in SAP DMS is then an error-prone process that can involve a lot of manual work. And ensuring the quality of printed labels is also one of the problematic steps in a regulated environment. Either the traceability of the labels is difficult, the status of the label is not recognizable or versioning is missing.

Document control and conversion

The solution here is characterized by the automatic application of release stamps. Originals are automatically converted into a PDF upon release, so that stamps, any data from SAP and other steering information (who printed? When did it print?) can be added very easily and quickly. With PDF, especially the standardized PDF variant PDF/A, it is ensured that the document always looks the same. To ensure that the correct file is always used, the originals are made invisible to all approved documents by means of a filter. This means that from now on only the PDF is visible in the document info record in SAP.

Document Output for SAP

During output of documents via the SEAL Systems solution an additional module in SAP is called, which finds all linked documents and outputs them together with the production documents. Which documents are collected can be determined individually by filter criteria and can be changed easily. Also a different configuration per plant, dispatcher or production control is possible.