Production in the pharmaceutical and biotech industries is characterized by the highest standards of product quality, documentation and product safety. In view of global markets and increasing digitalization, life science companies are now required to ensure qualitative product safety, data integrity and traceability.

Due to the increased requirements of the FDA, data integrity & traceability, a high level of automation and digitalization are almost mandatory to ensure operational performance.

Orise is the leading integration partner of the life science industry

 

Our team supports the life science industry worldwide with automation, digitalization, and optimization solutions throughout the production chain. The life science industry encompasses a wide range of organizations, including companies, businesses, and research institutions, all dedicated to improving quality of life.

#pharma

Pharmaceuticals

Orise provides seamless horizontal and vertical integration from the shop floor to ERP systems. These efforts ensure quality control and data integrity across automation and digitalization, including:

– Line monitoring solutions
– SCADA systems
– Recipe control following the ISA S88 and S95 standards

Orise also specializes in digital transformation to enable paperless manufacturing. Solutions include:

 

  • MES (Manufacturing Execution Systems)
  • EBR (Electronic Batch Records)
  • LIMS (Laboratory Information Management Systems)
  • Data historian and manufacturing intelligence systems
  • IT/OT security and reliability methodologies
  • Business process modeling and requirements engineering
  • Qualification and validation in alignment with GAMP5 standards

 

#biotech

Biotechnology

Orise delivers comprehensive upstream and downstream automation, including media preparation and utility integration. Expertise includes:

  • Collaboration with skid suppliers for seamless implementation
  • Experience in single-use equipment integration
  • Execution of large DCS (Distributed Control Systems) and MES projects with batch processing compliant with ISA88 standards

Orise also advances biotechnology operations with digital transformation initiatives, promoting paperless manufacturing through MES, EBR, LIMS, and other intelligence systems.

#formfillfin

Formulation, Fill, and Finishing

Orise offers advanced automation and integration services tailored to formulation, fill, and finishing (FFF) processes in the life sciences industry. By leveraging state-of-the-art solutions, Orise ensures precision, efficiency, and compliance across production. Key services include:

 

  • Automated filling lines with integrated quality control measures
  • Seamless batch management and traceability for formulation processes
  • Scalable solutions to adapt to varying production volumes and product specifications
  • Validation and qualification to meet stringent regulatory standards

 

With Orise’s expertise in FFF operations, companies can improve throughput, minimize operational risks, and maintain the highest quality across finished products.

#cmo

Contract Manufacturing Organizations (CMOs)

Orise collaborates with contract manufacturing organizations to streamline production and ensure compliance with industry regulations. Orise supports CMOs in:

  • Scaling operations to meet increased production demands
  • Implementing robust MES and EBR systems for traceability and reporting
  • Automating quality control processes to reduce manual interventions
  • Integrating supply chain and production for end-to-end visibility
  • Ensuring regulatory compliance through validation services tailored to GAMP5 and FDA regulations

Partnering with Orise enables CMOs to maximize efficiency and gain a competitive edge in contract manufacturing, delivering high-quality products on time and within budget.

PA Solutions is the leading integration partner of the life science industry

PA supports the life science industry worldwide with automation and digitalization solutions along the production chain. The life science industry is a broad term for companies, businesses and research institutions dedicated to improving life.
Pharmaceuticals

We provide horizontal and vertical integration from shop floor to ERP. Quality control and data integrity throughout automation and digitalization. Line monitoring, SCADA. Recipe control according to the ISA s88 and s95 standards.

 

Digital transformation and paperless manufacturing. MES, EBR, LIMS, data historian and manufacturing intelligence systems. IT/OT security and reliability methodology. Business process modeling and requirement engineering. Qualification and validation according to GAMP5.

Biotechnology

PA offers upstream and downstream automation, including media preparation and utilities. Integration and handling of skid suppliers. Experience in single-use equipment. Execution of large DCS and MES projects with batches according to ISA88.

 

Digital transformation and paperless manufacturing. MES, EBR, LIMS, data historian and manufacturing intelligence systems. IT/OT security and reliability methodology. Business process modeling and requirement engineering. Qualification and validation according to GAMP5.

Nutraceuticals

PA is the partner of nutraceutical manufacturers for automation and digitalization – from design and build to maintain. We support our customers with EI&C projects (execution), engineering (EPCM) and turnkey projects (EPC).

Medical devices

PA automates and digitizes the manufacturing processes of medical technology companies. Our offer covers design, build and maintain of automation and digitalization solutions, EI&C projects (execution), engineering (EPCM) and turnkey projects (EPC).

Why PA is the partner of choice for the life science industry

 

PA provides solutions and services across the life cycle of your automation assets, deploying best practices with project management, control strategies and design across multiple automation controller platforms. As a global system integrator in the life science business, we have the ability to scale and standardize our solutions uniformly automation, including media preparation and utilities.

 

We drive operational performance. Proven in practice.

With our automation solutions, we increase operational efficiency and create added value for our customers. Examples from practice include:

Execution of large DCS and MES projects with batches according to ISA88

Data integration and manufacturing intelligence

Electronic batch recording (EBR)

Experience with (m)RNA processes

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