Pharma Digitalization Landscape Survey

Your input is essential to support PDA's understanding of current digitalization efforts.

The following survey from the Drug Manufacturing Digitalization Roadmap Committee will assist PDA's efforts to recognize areas of opportunity and prioritize efforts promoting digitalization to drive innovation, efficiency, and competitiveness in the pharmaceutical industry.

Question Title

* Current Digitalization Practices: Please assess the current level of digitalization in your pharmaceutical operations using a scale from 1 to 5:
1 = minimal digitalization (e.g., predominantly paper-based processes)
2 = some digital implementation
3 = moderate digital integration
4 = high degree of digital maturity
5 = advanced digital integration with optimized processes and advanced data utilization

Question Title

* Challenges in Digitalization Adoption: What is the primary challenge your organization faces in adopting digital technologies within the pharmaceutical manufacturing process?

Lack of awareness about available digital solutions

Budget constraints for implementing digital initiatives

Concerns about data security and compliance

Resistance to change among employees

Digital and data science literacy of the organization; Lack of strong data culture

Other (please specify)

Question Title

* Digitalization Impact on Process Efficiency and Product Quality: To what extent do you believe digitalization has positively impacted both the efficiency of your pharmaceutical manufacturing processes (e.g., robustness, deviations, turnaround times, reworks) and the overall quality of your parenteral drug products?

Not at all

Slightly

Moderately

Significantly

Question Title

* Areas for Improvement: In which specific areas of pharmaceutical operations do you identify the greatest need for improvement through increased digitalization? (Select up to three)

	Area 1	Area 2	Area 3
Research and Development	Research and Development Area 1	Research and Development Area 2	Research and Development Area 3
Production (Upstream / Downstream Processing, Drug Substance / Drug Product Manufacturing, Primary Packaging, ATMPs)	Production (Upstream / Downstream Processing, Drug Substance / Drug Product Manufacturing, Primary Packaging, ATMPs) Area 1	Production (Upstream / Downstream Processing, Drug Substance / Drug Product Manufacturing, Primary Packaging, ATMPs) Area 2	Production (Upstream / Downstream Processing, Drug Substance / Drug Product Manufacturing, Primary Packaging, ATMPs) Area 3
Quality Control and Assurance	Quality Control and Assurance Area 1	Quality Control and Assurance Area 2	Quality Control and Assurance Area 3
Supply Chain Management, Transport, Distribution, and Recalls	Supply Chain Management, Transport, Distribution, and Recalls Area 1	Supply Chain Management, Transport, Distribution, and Recalls Area 2	Supply Chain Management, Transport, Distribution, and Recalls Area 3
Regulatory Compliance	Regulatory Compliance Area 1	Regulatory Compliance Area 2	Regulatory Compliance Area 3
Quality Systems (Record management, audits, change management, etc.)	Quality Systems (Record management, audits, change management, etc.) Area 1	Quality Systems (Record management, audits, change management, etc.) Area 2	Quality Systems (Record management, audits, change management, etc.) Area 3
Data Governance and Integrity	Data Governance and Integrity Area 1	Data Governance and Integrity Area 2	Data Governance and Integrity Area 3

Other (please specify)

The following demographic information will ensure PDA gains insight from all relevant stakeholders.

Question Title

* Which type of organization do you belong to?

Innovator

Generic/Biosimilar

CDMO

Component/raw materials Supplier

Consulting

Laboratory services

Other (please specify)

Question Title

* What is your job position/function?

Technician/Operator

Scientist/Engineer

Supervisor/Team Leader

Manager/Director/Executive

Question Title

* In the field of parenteral drug manufacturing, please specify the specific area in which you primarily work. Select the most relevant option:

Formulation and Development

Production

Aseptic Processing

Sterilization Processes

Fill and Finish Operations

Quality Control and Assurance

Regulatory Affairs

Equipment and Facility Engineering

Process Validation

Other (please specify)

Question Title

* Where is your primary location?

N. America

S. America

Europe

Asia

Africa

Australia

Question Title

* What size is your organization?

1-50

51-100

101-500

501-1000

>1000