SAP FOR THE PHARMACEUTICAL INDUSTRY

DIGITIZATION OF VALIDATION PROCEDURES AND BATCH RECORDS

As a sensitive industry with a direct impact on human health, the pharmaceutical industry is one of the most strictly regulated industries in Germany and worldwide. Due to complex validation processes and strict approval guidelines, the data load is very high. Manual processing involves many sources of error and is very time-consuming. For this reason, it makes sense to transform and digitize the validation process.

With fkon, pharmaceutical companies have an experienced consulting firm at their side that makes validation measures practicable and digitizes them within the framework of a previously created risk matrix. With our expertise in the pharmaceutical industry, we have developed best-practice solutions to digitalize complete processes and, in doing so, to carry out the migration of master data from the old data system to SAP within the framework of the validation guidelines in a resource-saving manner.

With SAP, entire processes of pharmaceutical companies can be digitalized. This includes, for example, approval management for different markets, stability tests, batch protocols, or validation processes.

DIGITALIZATION OF VALIDATION PROCESSES

We support pharmaceutical companies in the complete digitalization of validation procedures. SAP enables all processes to be digitally stored with individually selectable test criteria and validation levels. Thanks to a digital signature, the new system is tamper-proof.

DIGITIZATION OF BATCH RECORDS

The digital batch record in the SAP system makes the complete production and origin process of individual components transparent and shows exactly who, what, when and which process parameter was used. It covers the Good Manufacturing Practice (GMP) requirements for a processing log for each batch produced and contains all quality-relevant planned and actual data for the batch production.

The digital batch record consists of several documents that can contain the relevant data of certain ERP objects as well as data from external systems. The structure and contents of the batch record comply with international standards that are defined in the GMP guidelines. Digital batch records are stored in an optical archive to protect them against forgery and can then be approved using a digital signature.

A version of a batch record contains the following parts at maximum scope:

1. One document each for the table of contents and version data of the batch record (ensure that the scope and status of the batch records are documented and can thus be verified);
2. Document, with deviations from the batch;

3. Documents for the following ERP objects:
   • all process orders to which the batch has been assigned;
   • material lists of these process orders;
   • PI sheets for process orders;
   • process messages for the process orders;
   • all inspection lots for a batch;

4. Document for company-specific ERP user data;

5. Installation with archive files from external systems (e.g. raw data from process control systems or labels);

6. All comments entered for the version;

7. All electronic signatures provided during the approval process;

The digital batch record is redundant because the data records stored in the SAP database, including the application logic, are additionally stored as PDF in the document management system. This ensures that the data remains available and interpretable even after a system change.

DIGITIZATION, ADMISSIONS MANAGEMENT & STABILITY TESTING

Especially when it comes to managing complex regulatory standards, SAP can dramatically increase the efficiency of a pharmaceutical company. Since each market has different approval guidelines for drugs and their components, it is much easier to make the characteristics of the individual components digitally available and multiply applicable.

This also applies to the management of stability testing. All test series that are relevant for the initial approval or revalidation of a drug can be digitally stored and made available in SAP. Our team will be happy to advise and support you in tailoring SAP to the individual structural needs of your company.