Quality IT services for Life Science

Quality IT solutions for the life science industry.
Insight-driven, GxP-compliant.

We provide quality IT services for the life science industry, combining strategic consulting, custom implementation, and full-scope validation. We’re one step ahead of the competition because we take a step back to analyze processes before taking action. With our over-20-year experience, unique approach, and comprehensive expertise, we’ll help you optimize operations, reduce costs, and minimize time to market with zero compliance risk.

Services and solutions
Find out how we can help you accelerate your business and stay compliant with changing regulations

IT quality consulting

We’ll take you a step back to help you jump forward. Unlike most other contractors, we’ll delve into your organization’s processes, systems, and procedures to make sure we provide solutions that are fully:

  • compatible with your business environment,
  • compliant with regulations,
  • aligned with your needs and goals.

 

We offer business and process consulting spanning:

  • processes, including adjusting processes to support the handling of side effect complaints, post-market surveillance, and more,
  • tools analysis, including a tool audit, gap identification, tool improvement recommendations, adjusting tools and procedures for GxP compliance, and more,
  • GxP-relevant systems, including QMS, LMS, HCM, regulatory, and more, all provided by domain experts, including highly qualified software developers.

 

Leveraging our comprehensive life science expertise, we’ll help you verify your strategy in critical areas, including technology, human capital, DevOps, cloud, and validation, to minimize risk factors, optimize operations, and boost your performance.

Last but not least, we always keep abreast of the latest regulations. We can not only ensure your company’s compliance with laws and GxP at a given time but also help you keep track of legal developments and adapt your environment to changing requirements.

IT staff augmentation with GxP expertise

Human capital is a key driver of growth, innovation, and business success. We have helped a lot of life science companies scale by augmenting their teams with highly skilled professionals and extensive domain expertise. We’ll be happy to support your business with both qualified personnel and custom training.

We provide QA/CSV specialists and teams for individual projects as well as long-term, strategic collaboration. Our experts have vast experience in the field of GxP and stay up-to-date with life science regulations.

If you prefer to rely on your own personnel, we can provide your staff with comprehensive GxP training (including GMP, GLP, and GCP) tailored to your business needs, so that your team can efficiently handle projects in compliance with quality and legal requirements.

Click here for our detailed IT outsourcing offer

Compliance-focused cloud services

Moving your operations from on-premise to the cloud allows you to scale your business efficiently and drive growth for your company. We’ll craft a migration strategy for your IT infrastructure and ensure a smooth transition process.

We know the importance of quality and security in the life science industry. With in-depth domain expertise and an insight-based approach, we can provide you with the best-fitting solutions and hassle-free migration to a fully GxP-compliant environment.

We handle everything from the start, including:

  • data migration process compliance,
  • in-depth needs analysis,
  • data integrity assurance, including data testing,
  • auditing a cloud provider’s performance, security, and compliance (Azure, Kubernetes, etc.),
  • DevOps support, including quality maintenance for your platform, release/change handling, and documentation management,
  • tests covering the order handling process, manufacturing execution systems, and laboratory operations,
  • configuration monitoring at every stage of the implementation,
  • maintaining your cloud platform and quality processes in a validated state, and more.

 

We tailor the scope of the cooperation to your individual needs.

CSV services

Computer System Validation (CSV) plays a crucial role in the life science industry. It confirms the system’s conformity with regulatory guidelines and enables quality control for IT infrastructure, minimizing operational hazards and the risk of technology breakdowns.

We’ve completed hundreds of CSV projects for life science companies and gained unparalleled experience dealing with a range of issues. We understand the criticality of data security and have extensive expertise in handling data integrity within the GxP environment. We stay tuned to the regulatory changes and know how to maintain software in a validated state throughout its lifecycle.

We’re always ready to provide you with in-depth consulting before embarking on the project to analyze your needs and suggest the best approach with full compliance and efficiency in mind.

Our CSV services include:

  • IT infrastructure qualification,
  • data integrity assurance including data testing.
  • software validation (GAMP 5.0, CSA, Agile),
  • software quality assurance.
  • maintenance of the validated state, and more.

DevValOps TOOL – SPEED Up AND AUTOMATE Validation Process

Balancing quality and efficiency is tough. Especially so in a fast-paced software development environment, with GxP requirements only adding to the burden and complexity. We address that challenge with our original DevValOps approach, combining DevOps and validation.

Based on our life science expertise, DevValOps provides validation insights and reports within your existing development tools and CI/CD pipelines. Implementing it will streamline your processes, minimize error risk, and reduce validation documentation overhead.

Key DevValOps benefits include:

  • faster time to market thanks to instantaneous QA feedback,
  • better quality control with repeatable and autonomous tests and reports,
  • cost reduction by eliminating laborious manual work,
  • lowering friction of onboarding new team members with a standardized process.

24/7 support

We understand that businesses operate on different schedules around the world, and we’re committed to being there for our clients whenever they need us. That’s why we provide 24/7 support in all time zones.

Whether you’re in New York or Tokyo, London or Sydney, our consultants are available to assist you with any technical issues or questions you may have. With our global reach and expertise, we can provide fast and effective solutions to any problem. Our priority is to ensure the smooth operation of your business at any time of the day or night, regardless of its geographical location.

eConsulting life science division in numbers

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satisfied clients from life science industry

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onboarded IT specialists

including developers, database engineers, DevOps, UX/UI, test automation engineers

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CSV consultants

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languages

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countries

successfully delivered projects in more than 30 countries

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branches:

in the US, Switzerland, and Poland

24/7 support

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CONTACT

Let us be your success Partner!

Marianna Demczuk-Ignyś Business Development Manager

Michał Mroczkiewicz Business Development Manager

Request a consultation

Do not hesitate to contact us to get the best services! Call us or you can leave your number below and we will contact you.

Marianna Demczuk-Ignys CONTACT FORM

Michał Mroczkiewicz CONTACT FORM

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