A New (Science-Led) Approach to IT and Technical Support for the Pharmaceutical Industry

Digital transformation concepts and new technologies are changing the pharmaceutical industry, from individual processes in labs and on production lines to the way businesses operate. With technologies being at the center of these transformational changes, it is essential that IT and technical support also evolve. The traditional ways of doing things are not enough in pharmaceutical facilities that are increasingly digitalized and data-driven.

It’s also not enough to evolve IT and technical support along standard lines with the introduction of features like AI, self-service tools, and automation. Those things are, of course, essential.

In the pharmaceutical industry, however, we need to go further: IT and technical support must be science-led.

Modernizing IT and Technical Support with a Scientific and Compliance Focus

What does science-led IT and technical support mean in practice? You still need all the traditional essentials. Here are some examples:

You also need skills and capabilities within your IT and technical support team that cross deeply into the scientific and compliance arenas.

This means your IT and technical team should have expertise in:

• Compliance
• Validation
• Laboratory applications
• Lab equipment monitoring and maintenance
• Operational technologies on production lines
• Quality processes and quality management systems (QMS)
• Data management and optimization
• Laboratory process optimization and automation

With the above skills and capabilities in addition to traditional IT expertise, your facility will benefit from technical support that is fit for purpose and science led.

Science-Led IT and Technical Support in Practice

Compliance

The engineers providing IT and technical support to your pharmaceutical facility should have comprehensive knowledge and experience in:

• FDA regulations, including 21 CFR Part 11
• GLP, GMP, and quality system requirements
• EU regulations, including Annex 11 covering computerized systems
• GAMP5
• Service delivery in compliance with ISO 9001 and ISO 13485

Validation

The validation and verification expertise and capabilities of your IT and technical support team should include:

• CSV (computer system validation) and CSA (computer software assurance)
• Creating and updating validation master plans and validation templates
• Equipment validation – IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification)
• Validating IT infrastructure

Laboratory Applications

Laboratory software applications are complex and highly specific. Support from application vendors is important, but you will optimize processes and your use of laboratory applications if your IT and technical support team also have skills in commonly used laboratory applications.

Vendor selection and license optimization capabilities and experience are also essential to ensure you get the right applications for your requirements with optimized costs.

Equipment Monitoring and Maintenance

Science-led IT and technical support solutions can include lab instrument validation, calibration, and administration, enhancing lab performance, compliance, and efficiency.

Operational Technologies on Production Lines

The operational technologies (OT) and systems crucial to your product lines are likely to be separate from the IT systems and infrastructure of your organization. Therefore, it is highly beneficial if your technical support service has expertise not just with IT systems, but also with OT systems. This is especially important as IT and OT infrastructures continue to converge as part of digital transformation initiatives.

Quality Processes and QMS

An IT and technical support team that takes a science-led approach to service delivery will also offer quality process and QMS capabilities/expertise. This includes:

• CAPA (corrective and preventative action) support and batch record reviews
• Auditing of quality documents, procedures, and processes for efficiency, effectiveness, and compliance

Data Management and Optimization

Data is becoming increasingly important to pharmaceutical facilities as production, laboratory, and business processes are digitalized and automated. The efficient and effective use of data is also essential for compliance and quality management.

As a result, your IT and technical support team should have expertise in data standardization, integration, processing, storing, and reporting.

Lab Process Automation and Optimization

Continuous improvement and digital transformation are core priorities for forward-thinking pharmaceutical operations. Your IT and technical support resources can play a key role in the modernization, automation, and optimization of your laboratory operations. Examples include:

• Testing support, including chromatography systems, test method validations, and performance analysis
• SOP (standard operating procedure) reviews with an emphasis on digitalizing methods

Making Science-Led IT and Technical Support the Norm

There are multiple areas that make pharmaceutical operations unique from operations in other industries, including other manufacturing companies. Compliance and patient safety requirements are high up on that list, in addition to the high-volume nature of production processes, the narrow margins that must be managed within supply chains, and the commercial sensitivities that demand tight risk management.

Pharmaceutical operations are also modernizing, introducing new technologies, increasing automation, and transitioning to data-driven ways of working.

All these factors highlight the importance of evolving IT and technical support, retaining essential core skills and capabilities while adding scientific, OT, and compliance capabilities into the mix.

At Westbourne, this is our unique area of expertise. We are an IT and technical support solution provider that focuses on delivering services to customers in the pharmaceutical sector. For a science-led approach to IT and technical support delivery, get in touch to arrange a consultation.

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