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Early Stage Pharmaceutical Companies Need Tight IT Controls

Is Tight IT Control the Road to Digital Success in Pharma?

The pharmaceutical sector continually strives towards innovative new treatments to help people live healthier and longer lives. With increasing demand for quality medicines and unparalleled services, the scope of start-up biotechnology companies is enormous. However, the cut-throat competition and dynamic environment makes is quite challenging to face the risks.

This article is intended help early phase pharmaceutical companies hold a strong position in the industry by providing a checklist that is imperative for their growth and success. As the industry not only provides medication and treatment to the patients, but also discovers, develops, and markets drugs and services. They also deal with patenting, testing, efficiency, and safety of drugs.

The complexity of Pharma environment makes it essential for companies to pay attention to all the probable issues and their best solution. When we talk about the complexities, they often come from the IT sector as things have gone digital and it has become a necessity to entertain people the way they want. 

What is IT Control?

Before heading further, it is imperative to understand the term ‘IT Control’. An IT control is a procedure or policy that provides a reasonable assurance that the Information Technology (IT) used by a company or organization operated as per the set guidelines. IT controls can either be General Controls (ITGC) or Application Controls (ITAC).                    

Integrating the Latest IT Technologies to Revolutionize Medical Treatments!

Bringing Data, Devices, and Medicines Together!

From storing sensitive data into the cloud to using mobile apps for leveraging the Pharma processes, IT has become an integral part of the industry. Also, the digital transformation of the pharmaceutical industry is being applauded by everyone. The innovation can be seen everywhere right from R&D, manufacturing, distribution, and consumer health. 

Clinical trial development, enterprise application integration, research & development, regulatory compliance, benefit & risk management, and multi-channel marketing are some areas where IT control is imperative with everything going digital. An effective solution will not only speed up drug discovery but also improve the way things work.

The tight IT control can help start-ups and enterprises plan and execute digital strategies along with developing outstanding solutions and experiences with end-to-end services. 

IT Deployments are the New Face of Pharma

An era of integrating powerful cloud-based networks to 3D Printing!

With the increased adoption of IT in pharmaceutical industry applications comes more complexity which demands tight IT controls. Pharma companies need a way to control the new computing and service solutions with IT deployments becoming the new face of Pharma. Also, when technology is constantly evolving, companies need immediate attention.

Immediate support, ongoing assessment, long-term asset management, and expert consultations are key solutions that Pharma companies need today. Prompt and expert support is extremely important to deliver on promises of innovation and evolution and ongoing assessment of what’s happening in the IT environment.

In the race to develop innovative products and solutions, organizations are facing complex challenges that need to be addressed efficiently and with speed.

A Robust IT Control Strategy is Non-Negotiable

The key to successful IT Control is – the Product & Process!

Not only a tight IT control is vital for making products, but it is also a key driver for proper management of such a vast industry. A good strategy is a planned set of controls taken to effectively manage a product and process. It must also comprehensively consider the end customer along with the product while ensuring quality, safety, and efficacy.

An effective control strategy requires a structured process and a team of experts to link everything right from the manufacturing process and drug development to the engineering controls. For an early-stage pharmaceutical company, a robust control strategy can be established by following the best principles. 

Whatever strategy you choose, it must be implemented early on and continuously monitored and updated as needed, at every phase of the development and distribution.

An Interdisciplinary 4-Stage Approach

End Customers, Products, Production, & Process makes an ideal strategy!

To develop a powerful IT control strategy, you need to involve a multi-disciplinary team of experts. And they should be able to handle the 4-stage approach – the end customers, the products, the production, and the process. Both service users and service providers can give their input on how the product and services should ideally be designed.

Once the product is designed, you need to emphasize product quality, safety, and efficacy. It will lead to an evaluation of the proposed manufacturing process to make the process of production. Using scientific and risk-based principles, you can continue with the production. A facility-dependent evaluation and probability of the failure will help determine the risk.

It is imperative that everything can be integrated into the overall control strategy as the process and the solutions overlap.

What’s Trending with IT in Pharmaceutical Companies?

We cannot understand the scope of tight IT controls without knowing what’s trending in Pharma as IT is evolving every single day.

Here is the list of some trending IT trends that are being noticed…

  • Life science companies have high IT intensity and often need a higher portion of their budgets for maintaining a data center and network infrastructure.
  • The pharmaceutical companies are outsourcing their IT risk to technology companies that specialize in this niche – end-to-end design, administration and management of network infrastructure.
  • The flow of process/machine data from the production line to the executive suite is increased as everything is going digital.
  • Pharma companies are using Information technology to integrate more functionality and value into their existing infrastructure.
  • With the increasing use of smart devices and online apps by customers, the Pharma companies are replacing all their processes with digital tools and systems.
  • Customers, manufacturers, vertical partners and distribution channels are looking for customized software these days that they can access from anywhere, leading to the expansion in the IT involvement in Pharma companies.

Today’s modern-in-memory computing platforms has made it almost mandatory for every sector to integrate IT into their functionality. Though the connected informatics infrastructures help organizations achieve higher-level goals, they also demand tight IT controls.

How is it Possible to Enforce Tight IT Controls?

Whether it is an early-stage pharmaceutical company or a well-established one, IT plays a crucial role and has to be dealt with productively. And the most important factor is that the organizations should have proper processes in place to identify, communicate, and rectify discrepancies in the set objectives.

The following points might help you with enforcing tight IT controls…

IT Control activities often refer to the policies and procedures that are used to assure that all systems, digital tools, policies and procedures are adhered to at all times – be in a state of audit-ready at all times. This ensures that everyone is following the guidelines as provided by the management. Though control activities may differ based on the business environment, some basics need to follow.       

  • Communication is the key: No information system can be effective without proper communication between different levels of management. Whether it is internal or external communication, it has to be properly documented and followed.
  • Using Control Software can be the Solution: A control software may refer to a technology that restricts the content a user is authorized to access. Using such software, the Pharma companies can better manage all their digital environments and also ensure that the same level of control can be maintained remotely.
  • Outcome-Based Control System is Moving to Center Stage: IT is reshaping the healthcare industry and also leading to more complex challenges. Generating the data that Parma companies need to reach superior efficacy is all based on the outcomes.
  • Customers, Partners and Vendors are Becoming More Engaged: In a digital age, all business partners are looking for ways like an application to stay updated. A Pharma company has to engage with patients as they make any evaluation and at the same time having control of information is imperative.
  • Continuous Monitoring Serves the Purpose: IT controls should be designed in a way that the activities and processes are monitored regularly. It will not only help the organization manage the effectiveness of the plans but also identify and rectify discrepancies. 
  • Consistency of Execution Makes it Happen: Control is a process that is executed by people and consistency in the execution ensures effective implementation of a control system. Everyone should be aware of the relevant procedures.
  • Change is the Only Stable Thing: With technology evolving with every passing day, everything is dynamic and so should be the control system. Checks and balances have to be updated to keep up with the pace and functioning of the organization.

Why do Early-Stage Pharmaceutical Companies need Tight IT Controls?

It is imperative that Early-stage pharma plans and implements tight IT controls because it gets incrementally harder and more expensive as the organization grows.

The following reasons might help understand the complexity…

  • An ocean of information is available about products and services online that makes it difficult for Pharma companies to remain the main source of authority.
  • Customers, partners, consultants, legal, distributors, manufactures and all business partners are empowered with access to online resources such as apps, smart gadgets, etc.
  • New competitors are moving in and they have an insight into more data than ever before and companies need to deploy next-generation technologies to keep up and ensure that their IP, and inventions are always protected.
  • With a plethora of smart gadgets available on the market, it becomes a vital concern to control the information they receive and share at all times.

How can iSectra help?

At iSectra we have worked with Early-stage Pharmaceutical companies for the last 15+ years. While we have customers in other industries, our focus and specializations are building up infrastructure, systems, IT policies and procedures and end-to-end management of systems for our customers in this industry. We have been on the early founding team of Pharma companies and seen them all the way to growth, maturity and exit to IPOs and mergers. Our team understands the importance of tight IT controls in Pharmaceutical organizations because we have learned from the challenges and successes of our customers over these 15+ years. Please feel free to reach out to us anytime to discuss your company and its needs. There is no obligation to buy any service. We are always looking to learn from this industry and every conversation is a learning experience for us and it adds to our body of knowledge that we are constantly sharing with our customers.

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