Sector focus pharmaceutical industry

In the pharmaceutical environment, legal regulations are particularly strict; the regulatory requirements for IT systems are extraordinarily high. Especially in this area, the implementation of a new ERP system presents companies with great challenges.

The focus is on clearly defining processes and mapping them in the new ERP system. What is more, the pharmaceutical industry must take into account regulations to ensure safety, seamless batch traceability, and consistent compliance. At the same time, the business goals of a new ERP system should not be ignored: increased profitability, maximum flexibility, automation of business processes, improved data and decision-making quality, scalability, depending on company growth, and sustainability due to suitable digitalization.

Validation

In the implementation of a new ERP system, validation is particularly significant. In the context of “Good Manufacturing Practice” (GMP), there must be documentary evidence that IT systems are suitable for the intended purpose, for example electronic batch traceability or batch release. “Good Manufacturing Practice” involves international and national provisions and guidelines that ensure that pharmaceutical products are consistently produced in accordance with defined quality standards. If it does not adhere to GMP provisions, a business does not receive a manufacturing permit.

Every IT system used in planning, production, quality control, and quality assurance is therefore relevant to validation, so it can be ensured that within the company no risk arises for people, product quality or data integrity. A new ERP system must therefore function as previously described. This corresponds to the goals of GAMP® 5, “A Risk-Based Approach to Compliant GxP Computerized Systems”. System usage is validated by an independent body.

Detailed regulation with the V-model

GAMP® 5 (Good Automated Manufacturing Practice Forum) is a recognized standard guideline in the pharmaceutical sector for the validation of computer-supported systems with the V model. In this process model for the planning and execution of projects, activities and results are defined. On the left are planning and requirements, on the right are actions and results. In addition, the V model defines the responsibilities of each participant. In other words, the V model stipulates in detail WHO has to do WHAT and WHEN. 

To put it in very clear terms: It is not the ERP system itself that is validated, but rather the IT-supported processes – in other words the way in which the ERP system is used. In the end it is the pharmaceutical company that takes responsibility for the use of an ERP system that meets the requirements of a norm or a statutory provision. But the ERP provider, too, contributes to successful validation, as it must provide sufficient and individually adaptable ERP functions that are required for correct usage.

Detailed regulation with the V-model

expertplace has comprehensive and demonstrable sector experience in industrial and retail pharmaceuticals. Typical ERP sector topics and processes that we implement:

  • Mapping of process manufacturing with multi-stage productionElectronic PI sheet and batch traceability
  • Recipe management and optimized master data maintenance
  • Inventory management and materials planning at the packaging level
  • Integrated document management for recipe and specification management
  • Integrated quality management with LIMS functionality
  • Dangerous goods and environment management as well as implementation of the REACH regulation
  • Automated creation of safety data sheets as part of the Ordinance on Hazardous Substances
  • Fulfillment of statutory and regulatory requirements or guidelines such as GxP, GMP and GAMP®

Project-accompanying validation from implementation to customizing Our consultants and project methodology have already won several awards.

As IT and management consultants, we create targeted IT planning, design optimum processes and implement them successfully with the appropriate IT system. That includes:

  • Process analysis, modeling and optimization
  • Evaluation of the software and IT infrastructure
  • Determination of future IT requirements
  • Creation of GxP-compliant specifications
  • Market and product analysis of IT systems
  • Comparison and selection of ERM, CRM, MES, and LIMS systems
  • Contract negotiations and creation of a decision template
  • GMP-compliant ERP implementation based on valid project methodology
  • Handling of project management and controlling
  • Project management taking into account the V model
  • Computer validation with GxP-compliant documentation
  • Support for change management
  • Quality management during the implementation