Life sciences and healthcare

Life sciences and healthcare companies operate in a strictly regulated environment with quality and traceability as the top priority. They need to manage complex product development and supply processes and meet global requirements, while mastering data, processes, and documentation in a consistent way.

Challenges

Life sciences and healthcare companies must efficiently coordinate research, development, production, and market access across multiple areas, locations, and partners.

Strict regulatory requirements and obligation to provide proof

Current Good Manufacturing Practice | cGMP, international standards (e.g., ISO 13485), and FDA regulations demand seamless documentation, audited processes, and audit-acceptable product data.

High complexity in development and documentation

CAD data, technical documents, recipes, and variants need to be managed consistently, with validities and versions – throughout long-term product lifecycles.

Global harmonization of data and processes

International locations need a joint data basis for ensuring standardization, scalability, and high process quality.

Life sciences and healthcare

Solutions

SAP-based PLM solutions support the controlled development, management, and provision of product information – from technical documents and product data to packaging and labeling information.

Seamless integration of CAD, Office, and technical documents

SAP ECTR directly connects authoring tools to the SAP system and allows for consistent product structures without media gaps.

Consistent, regulatory-compliant PLM

In regulated environments, Integrative PLM supports the seamless documentation of product data, changes, and certification processes – in a validated, audit-acceptable, and FDA-compliant manner.

Regulatory-compliant data basis for packaging and artwork

With the central specification management in SAP, all relevant packaging and content data is available in a controlled, audit-acceptable, and globally consistent man-ner, which is ideal for FDA, EU, or market requirements.

Your road map to real growth

In a no-obligation meeting, we will identify your individual challenges together
Experience live in a demo how you can achieve quick wins with SAP-based solutions
With a detailed analysis of your situation and potential, we lay the foundation for long-term success

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