| July 2020
Many large Pharma firms have hundreds of people in their IT department supporting a wide range of processes from the research and development of new products, through to supply chain management and into sales and marketing.
In every part of their organisation they need to ensure compliance and IT is no different. The solution for these firms is to hire dedicated IT Compliance professionals. However that may not be feasible for smaller Pharma businesses – companies who need the same degree of rigour, but lack the resources to manage this function internally. Indeed, many SMEs in the Pharma industry rely heavily on the skills and experience of external suppliers such as their IT Managed Service Provider (MSP).
Smaller companies may still have the unenviable challenge of dealing with nearly as many stakeholders as a large Pharma player with different groups having established policies, procedures, and controls at varying levels of detail and structure based on their definition of risk and their specific regulatory requirements.
Managed Service Providers have the skills and experience of managing both quality and IT to a high standard for SME businesses. Even better when these providers specialise in the Pharma sector itself, as this helps ensure that IT infrastructure and processes will be compliant with Pharma sector best practices.
The whole Pharma industry is on a digital transformation journey which requires new and innovative ways to ensure the required level of security and compliance for a regulated business. To be successful in this journey you need to ensure that you follow standard rules and regulations across GxP as well as non-GxP systems.
In many cases you may have established overlapping and redundant policies, standards, or procedures, and they do not follow a consistent set of documents. Policies, standards, and procedures may have references to inaccurate, missing, or incomplete information. Mergers and acquisitions have often further complicated this issue in the Pharma industry. And as the sharing of data digitally and across organisations increases, many find information security, privacy, and data archiving pose even greater challenges.
A proactive and risk-based technology governance, risk and compliance approach will allow your organisation to better manage the cost of compliance, to streamline compliance and business processes through increased automation and to fuel innovation.
You may well need an “advisor” in order to ensure the right level of quality is delivered and a specialist MSP can offer the services of a Virtual CIO who has specific expertise in IT for Pharma to help you with your responsibility to:
A specialist Managed Service Provider will have in-depth knowledge of the Pharma industry, MHRA standards and the related GxP regulations and will manage the execution and follow up on internal and regulatory inspections. For companies new to the sector, or seeking to gain fresh opportunities, this is particularly invaluable, and can help you to swiftly achieve proven baseline compliance, for example, by gaining Cyber Essentials Plus certification.
If you are looking for advice on how best to prepare for and succeed in today’s the booming Pharma sector, Epoq IT has a proven track record in the industry.
Epoq IT’s new Pharma Digital Toolkit is designed to optimise and accelerate the digital journey you have likely already started – for immediate impact on the bottom line and for longer-term success:
→ Build digital resilience and flexibility into your IT infrastructure to future-proof your business
→ Ensure your IT is set up and managed in a secure and compliant way that supports the standards required of companies operating in the Pharma sector
→ Use tools within your existing platform to develop cost and time-saving solutions and insights, designed around your business processes and goals
Download the e-book to find out how the Pharma Digital Toolkit can transform your ability to compete in today’s fast-moving digital world.
Written by Gary Swanwick
I lead Epoq-IT to deliver strategic IT service management, building strong relationships with SMEs to manage IT systems and services that support growth and align with business objectives.