CONYU IT&Workspaces
Information Technology, Cloud, And Gxp Compliance Made Easy

As the pharma industry faces numerous emerging challenges today, digitalisation has shown enormous potential in helping companies meet the increasing regulatory requirements. But, digitalisation in the sector is still in the preliminary stages. The current internal IT infrastructures and related processes require optimisation. At the same time, the validation of implemented software and the qualification of the hardware remains a monumental challenge for executives and quality managers. This scenario, coupled with the scarcity of skilled IT professionals, adversely influences the overall productivity of a pharmaceutical brand.

Right in the middle of this predicament stands the calming presence of IT, cloud, and GxP specialist CONYU. CONYU is an innovative IT services provider and consultancy firm that empowers pharmaceutical and life sciences companies to increase the productivity and flexibility of their operations by utilising the latest IT technologies. As an Infrastructure as a Service (IaaS), Software as a Service (SaaS), and Desktop as a Service (DaaS) provider, the company demonstrates the ability to offer managed services and promote environmental sustainability in a compliant manner, which stems from its decades-long experience in IT, quality management, and GxP environments.

“The 25 years of pharmaceutical experience of the CONYU team can meet the quality management requirements of any pharmaceutical and life sciences company,” says Arnim Schmid, CEO of CONYU.

With a widespread and readily available private cloud in northern Germany, CONYU operates servers and systems in qualified IT infrastructures in accordance with GDPR.

Its team takes a cooperative role and the onus of its clients’ security, backup, server maintenance, application management, audit-proof archiving, and validation and integration of various systems. CONYU’s IT experts advise pharma businesses on optimising their IT organisational structure and business processes to create faster and more efficient workflows.

Reliable and 24/7 Accessibility and Availability

CONYU develops effective strategies, reduces IT complexity, and offers tailored solutions for optimal pharma processes and seamless collaboration. The company comprises business experts who consult pharma companies of all sizes regarding digitalisation, large-scale projects, and organisational structures. These experts pool their expertise and know-how to devise IT strategies and solutions optimising related processes.

CONYU’s available and accessible cloud creates a secure and reliable network of IT servers, databases, applications, and infrastructure systems. To enable users to work flexibly and efficiently, the company blends its server infrastructure with its digital workplace technology to create a virtual working environment.

Through its pharmaceutical-oriented data center, CONYU ensures all the critical prerequisites for GxP-compliant operation. The company also conducts system validations for IT compliance, ensures pharmaceutical-compliant documentation, and carries out recovery tests. In addition, CONYU ensures business continuity and devises emergency plans for the customer’s systems and processes, giving users a great experience and incurring minimal downtime.

“With its operational support, CONYU functions as a very close partner to pharmaceutical companies and enables them to add higher value to their offerings,” elaborates Schmid.

IT system validation today is a critical part of pharma compliance that ensures the protection of patients and their data. But the process execution in an error-free, fully traceable, and consistent manner is often arduous and time-consuming.

CONYU simplifies and accelerates IT validation by applying appropriate GxP compliance strategies.

The company employs risk-based validation methodologies for cloud and SaaS systems and executes an integrated and routine follow-up process to check compliance. CONYU conducts installation qualification (IQ ) and verifies that devices and systems to be qualified are installed and configured per its clients’ specifications and installation checklist.

When a pharma company changes or updates existing IT systems, it must conduct change control–as part of quality management–to ensure that changes in any product or process are introduced in a monitored, controlled, and coordinated way. CONYU helps companies in these scenarios by enabling them to define the measures required to assess the changes and successfully implement them. CONYU also assists its clients in generating IT change requests, executing the design qualification process, and meeting design and manufacturing specifications promptly.

“If you value quality, you’ve come to the right place. Our private and specialised data centre ensures compliance with GxP, ICH, BaFin, DSGVO, FDA, 21 CFR Part 11, ITIL and ISO,” states Schmid.

With its operational support, CONYU functions as a very close partner to pharmaceutical companies and enables them to add higher value to their offerings

CONYU conducts risk analysis to identify and analyse potential risks that can adversely impact key business initiatives and ensures product functionality, safety, and reproducibility under various real-time scenarios.

"The 25 years of pharmaceutical experience of the CONYU team can meet the quality management requirements of any pharmaceutical and life sciences company"

As the world becomes increasingly digital, the transition from paper-based to digital recording is ubiquitous, even in the pharmaceutical industry.

CONYU helps businesses comply with FDA electronic documents and signature regulations and define the criteria under which these records and signatures are considered reliable and equivalent to paper records. It prepares the traceability matrix for the qualification of documents and summarises the validation results and procedures, ensuring consistent and compliant documentation.

Bringing Flexibility to Pharma with Virtual Workplaces

In the quagmire of the pandemic, workplaces in the pharma industry have drastically transformed. Businesses now face the unique challenge of infusing flexibility into their routine operations and improving the productivity of their workforce.

CONYU sets the stage for the industry and enables businesses to offer flexible working arrangements to their employees via CONYU’s virtual desktops.

“Characterized by the ability to publish software professionally, CONYU makes it possible for users to access their applications from anywhere and with any device,” states Schmid.

The cloud-based digital workspace is based on the latest technologies and allows users to work from anywhere, regardless of location, time, and end device. CONYU integrates virtual desktops and employs software and hardware to provide users with a seamless digital experience. The systems are hosted on the company’s central data centres in Germany and enable remote working in a pharma-compliant manner. The data centres are synchronically monitored and protected against disaster scenarios and technical failures.

Owing to CONYU’s extensive expertise in pharma compliance, the virtual desktops provide applications to users via secure access zero trust gates. CONYU’s ISO 27001, ISO 9001, and ITIL services, combined with good automated manufacturing practice (GAMP), enable it to identify and eliminate security vulnerabilities.

Helping businesses further enhance their security stature is CONYU’s backup and recovery testing services that prepare its clients for unforeseen events. In addition, CONYU also provides endpoint security services where it protects mobile devices, maintains multifactor authentications, and offers AI-based virus protection.

To enable pharma companies to focus on mission-critical processes, CONYU offers its fully managed services, where it manages all IT affairs and ensures reliability and compliance. CONYU provides a service desk that automates versioning, sorting, and full-text document management search and meets the requirements of modern workplace environments.

“As a provider of fully managed IT services that address all IT requirements, CONYU is a very reliable and competent partner,” adds Schmid. “We are not only the infrastructure team, we have qualified managers who cover the gamut of IT.”

Down-to-earth Approach Towards Complex IT Qualification

“Our strength lies in our down-to-earth approach to complex processes and in using simple and agile methods to bring projects to a successful conclusion,” explains Schmid.

CONYU employs a risk/process-based view and devises valuable and compliance focused strategies. The company carries out IT projects for pharmaceutical systems and integrates eQMS, ERP, clinical, fintech, and other systems. Each client is provided with a contact person who ensures the delivery of tailored IT solutions that offer higher availability, business continuity, and risk management.

Pharma organisations can avail CONYU’s comprehensive IT services on a modular basis and design each service to complement their unique operations. CONYU’s ITIL-based information technology service management (ITSM) fosters uniformity and transparency in all services, giving clients a holistic view of their IT operations and associated compliance.

The down-to-earth approach also includes CONYU’s initiative towards promoting environmental sustainability in IT environments.

CONYU employs green electricity and hosts the system in its cloud environment. This contributes to local communities, nature, and the world. For each server employed, CONYU plants a tree in its owned forest. Its independent and easy to-access cloud ensures higher system availability, reduces electronic scrap, and diminishes the long runtimes of hardware.

With these innovative and environmentally friendly technologies, numerous pharma businesses trust CONYU– medac GmbH, Photonamic GmbH & Co. KG, Oncotec GmbH, Hormosan GmbH–as IT service provider.

Its digital workplace has enabled flexible working models across many companies while its workforce benefits from the modern and seamless virtual workplace experience. Many of its clients can access SAP systems by integrating them into the digital workplace and react swiftly to hardware and software failures without IT support.

By virtue of the CONYU cloud, the company audits its systems for GxP compliance, legal requirements, and system validations.

As a pharmaceutical consulting company, CONYU has met the multitudinous regulatory requirements of its clients, successfully established its eQMS application for testing, and validated IT systems using its cloud. By bringing high levels of accessibility into IT environments, the company is fundamentally transforming how pharma companies employ technologies, enabling them to maintain regulatory approval and develop products more efficiently.