Comprehensive Services for the Pharmaceutical Industry: Cloud Solutions, Validation and Quality Systems
Cloud Services Supporting Compliance with the NIS2 Directive
Specialised cloud services designed to support organisations operating in the pharmaceutical sector in meeting the requirements of the NIS2 Directive, particularly in the areas of cybersecurity risk management, information systems resilience, and the continuity of critical business processes.
The solutions take into account the specific nature of regulated GxP environments and the importance of IT infrastructure in safeguarding public health.
NIS2-Compliant Support Scope:
- Cybersecurity risk management
- Network and information systems security
- Incident management
- Business continuity and operational resilience
- Accountability and auditability
Modern Life Sciences Cloud Platform for the Pharmaceutical and Healthcare Sectors
Key Platform Benefits (as-a-Service Model)
- Rapid Deployment – access to proven, ready-to-use components without the need to build infrastructure from scratch
- Cost Optimisation – the subscription-based model eliminates high capital expenditure (CAPEX) and allows organisations to pay only for the resources they actually use
- Continuous Updates and Compliance – the platform is continuously maintained in line with GxP regulations and industry best practices
- High Level of Security – built-in mechanisms for data protection, auditability, and access control
- Scalability and Flexibility – resources can be easily adjusted to meet changing business requirements
- Integration with Existing Systems – seamless connectivity with systems already in use across the organisation
- Availability and Reliability – guaranteed business continuity and secure access to data from any location
- Reduced Burden on IT Teams – the service provider handles maintenance, monitoring, and updates
This solution lets pharmaceutical and healthcare organisations focus on innovation and core operations, while experts handle the technology.
Through collaboration with our partners, we can offer modern, proven solutions that provide access to the latest AI/ML technologies.
Validation
We have our own team carrying out qualification and validation work for ongoing projects and revalidation of existing systems. Expert staff have over 15 years’ experience working in the EU GMP environment.
In addition, as part of our qualification and validation work, we provide services such as:.
- cleaning validation,
- cross-contamination,
- quality risk management,
- preparing plants for inspections,
- resolution of reported problems – GAP analysis,
- process validation and optimisation of manufacturing processes.
Consulting
We verify, analyse processes, data to meet legal requirements and qualitative acceptance criteria. We verify, analyse and check design solutions for room concepts, HVAC installations and automation guidelines HVAC, RMS, BMS against legal requirements and qualitative customer acceptance criteria. We provide solutions to optimise processes in line with available technology. We perform a gap analysis. We provide solutions to optimise processes in line with available technology. We identify risks and ways to reduce them. We support process managers and process owners by presenting the status quo and the necessary optimal, responsible actions to improve compliance with EU GMP requirements.
…today we plan what tomorrow will look like
- objective process evaluation supports the soundness of the decisions of those in charge,
- we provide evaluation results and solution proposals,
- we help develop and implement optimal improvement and development plans.
Outsourcing
Providing Quality Assurance services – we provide support in process validation, preparation for inspections, periodic reviews, qualification/requalification of buildings, computerised systems, ancillary systems – HVAC, purified water, compressed air and others, metering systems, inspections, change control, CAPA, risk management including cross-contamination risk management, cleaning validation and others.
We provide meritorial support and assistance with stacking work developing documentation. We have experience of improvements and facilitation in maintaining the validated/qualified status of medicinal products and supporting systems. We optimise operations according to the requirements of EU GMP.
- Risk management
- Consulting, advisory and optimisation
- Validation/revalidation
- External audits and inspection support
Inspection and the pharmaceutical quality system
The pharmaceutical Quality System is the backbone of a pharmaceutical company. However, not only specialised knowledge and experience, but also objective assessment of the level of implementation and maintenance is required to improve it and plan directions.
- Determining areas of manufacturing requiring preparation for
Inspection according to customer needs. - Determination of the scope of legal requirements and standards supporting compliance
with the requirements (list of products manufactured , processes carried out,
special conditions, etc.). - Establishment of reference documentation providing evidence of compliance
with the requirements
(procedures, instructions plans , protocols , reports etc.). - Establish a secure way to share documentation.
- Develop a requirements matrix to record the results of the remote audit:
– data entry,
– quantification of meeting requirements in %,
– designation of areas for improvement. - Proposals for CAPA urgent actions and long-term development strategies.
