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Outsourcing in the pharmaceutical industry - Oqotech

We talk about outsourcing in the pharmaceutical industry in services such as process engineering consulting and validation of computerized systems.

Outsourcing en la industria farmacéutica

Outsourcing is a resource employed by a company by which it hires a second company to develop a specific part of its business. By establishing this strategic alliance of collaboration in processes for which you have not developed special capabilities, you can keep your resources focused on the most strategic part of your industry. This translates into cost savings and improved quality, since the company provides specialization and flexibility to adapt to different workflows, in addition to having optimized techniques and highly developed proprietary systems. The result is a transformation of the business processes that favors the integration in the environment through productive synergies between both parts.

Why is outsourcing used in the pharmaceutical industry and what challenges does it pose?

Outsourcing has become a key component in the business strategies of pharmaceutical companies. On the one hand, it allows for considerable cost savings and, therefore, better ability to withstand the financial pressures to which they are subjected. This is because, in large part, relying on an expert partner specialized in different areas is more cost-effective than training and employing staff members. On the other hand, it allows companies to diversify their actions and to focus on responding to different demands, such as research and carrying out a growing number of clinical trials that guarantee the safety of medicines, as well as obtaining authorizations for the production of drugs.

What services are outsourced in the pharmaceutical industry?

The pharmaceutical industry, like companies in the health sector and the chemical industry, invests in technology to meet the requirements of auditors and regulations, both national and international. Now it finds in the outsourcing of services, which provides it with a specialized supplier, the answer to those needs in services such as process engineering consulting and validation of computerized systems.

Process engineering consulting and validation of computerized systems

OQOTECH is a consulting company specialized in computerizing critical business processes and validating computerized systems in regulated environments with the guarantee of the best service, with a highly qualified team and the experience of more than 10 years in the pharmaceutical industry sector.

Process engineering consulting, also known as process computerization or process automation, ensures the integration of computerized systems into the process in order to secure and optimize it. For this purpose, it is crucial to establish a methodology to implement digitalization based on the experience and knowledge of the members of the organization in the process, having clear the critical points of the process to be ensured and the information that must be recorded as evidence of the process for its traceability. With the knowledge and experience of a specialized company, the pharmaceutical industry is able to manage the change of model based on reliable and effective technology.

Benefits of process computerization

Thanks to the computerization of processes, companies in the sector can ensure and optimize processes and base their decision making on reliable data and indicators in real time, allocating resources efficiently and establishing the necessary controls. The result is greater quality and robustness of both the processes and the products they lead to. In the last decade, OQOTECH has implemented enterprise resource planning (ERP) systems, warehouse management systems (WMS), laboratory systems management (LIMS), document management (DMS), production control systems (MES), monitoring systems, control and data acquisition (SCADA), laboratory database systems, clinical or manufacturing, and Business Intelligence (BI).

Validation of computerized systems

The validation of computerized systems guarantees the operation of the system for its intended use in a documented and justified manner. Validation should be carried out by focusing on the process to be ensured, identifying all variables that may affect it as a risk. The main critical points to standardize and verify in the validation process are: the adherence of the application to the organization’s process, the operation of the application itself, the computer infrastructure that supports it to provide the system with computer resources, the service of external suppliers, the domain of the users who make use of the system and the integrity of the information processed and registered by the system. It must be taken into account that validation is not a finite process, it starts with the need to computerize a process, going through its implementation, use and later storage of the information (once the system is no longer in use).

Optimal validation is that which makes the new technology part of the daily lives of all users involved in its use by adopting new skills and tools, but also that which guarantees the integrity, throughout its life cycle, of the data generated in the system. In addition to this, the management of service providers is supervised and good maintenance and safety practices are verified. In the long term, the validation of computerized systems is very useful for planning the replacement of a specific technology by a new one.

System validation covers reviews of the operation of technological tools, user support and evaluation and control of tool providers and their services. An outsourced service provider in this area takes care of data integrity to ensure product security and quality, checks the entire IT infrastructure, and ultimately enables optimal maintenance and system continuity. All this, with a consideration of the computerized systems in an integral way.

How to choose an outsourcing service provider?

The importance of process engineering consulting and computerized system validation makes choosing the right outsourcing service provider a critical task. A mistake to be avoided is to trust a company that demands a lower economic outlay; looking at this criterion alone can translate into deficits that can lead to undesired consequences and much more expensive than the initial savings.

On the contrary, when making a decision, factors such as the fact that the supplier has a solid quality management system and that its technicians and engineers are qualified and have the necessary experience to carry out their functions should be given priority.

The future of outsourcing in the pharmaceutical industry

Today, outsourcing in the pharmaceutical industry already develops key services for companies that decide to rely on specialized external partners. From commercial, sales and marketing activities, it has evolved into areas such as information technology or process engineering consultancy, as well as the validation of computerized systems. The fact that the pharmaceutical industry has adapted less immediately than other sectors to the outsourcing of services does not mean that it cannot even lead the use of outsourcing in different areas.

The outlook for this is more optimistic than ever; pharmaceutical companies are expected to rely increasingly on external service providers for R&D and drug manufacturing. Also, that in the next few years investment in spending on specialized outsourced services will increase, a path to which biotechnology companies will also be added.

The use of the Big Data and the adoption of the cloud implies new challenges in a very fragmented environment, where the requirements of security in the use of data and the optimization of processes require integral solutions. Outsourcing will allow the application of disruptive methodologies and the adoption of new models, which will represent a competitive advantage over more traditional and inefficient uses.

Article originally published in PMFarma.

At Oqotech we help companies, mainly in the pharmaceutical, cosmetic and medical devices sectors, to implement and validate computerized systems for the control and optimization of their processes. Contact our team.

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