Expertise for hospitals, labs and pharmacies
As a trusted partner, we support hospitals, laboratories, and pharmacies elevating their quality standards.
With extensive expertise in PIC/S guidelines, current Good Manufacturing Practices, operational procedures, risk assessments, validations, quality systems, audit preparation, and tailored training programmes, we support hospitals, laboratories, and pharmacies in meeting the highest quality standards.
We have assisted numerous hospitals, laboratories, and pharmacies in various projects, from advising on new cleanroom construction to performing detailed particle counting in existing facilities. By conducting thorough analyses of design, documentation, measurements, and user information, we consistently enhance the quality of both employees and the services/products delivered.
Our approach within hospitals, laboratories, and pharmacies
As a staff member, it's sometimes easy to lose sight of the bigger picture when implementing new technologies, guidelines, or best practices. To maintain competitiveness and uphold standards equal to or better than other hospitals, laboratories, or pharmacies, it's crucial to anticipate innovation and support continuous improvement. Working in an innovative and validated production environment requires ensuring quality throughout the implementation of improvements. Every decision made can impact the final deployment.
We provide support throughout the entire process.
Improving Service and Product Quality
Our experts stay updated on the latest developments in the pharmaceutical and healthcare sectors, including regulations, quality systems, design, and technology. They are trained to implement this knowledge in hospitals, pharmacies, laboratories, and other settings, helping each organisation strive for a culture of improvement and innovation. Ensuring optimal quality often benefits from an external partner who can offer a fresh perspective on current operations. Through robust monitoring, method development, and validation, you can trust that delivered products and services maintain the highest standards of quality. By evaluating and optimising a client's current processes, this approach eliminates ambiguities, fosters future readiness, and improves cost-efficiency.
Efficiency Improvements
We have years of experience in the pharmaceutical and life sciences industries, where strict regulations and large, complex projects are commonplace. This foundation positions our team well to translate pharmaceutical sector principles and established methods to the hospital sector, which faces similar problems and uncertainties but with distinct regulatory and operational needs.
We provide consultancy for optimising the efficient flow of people and goods within cleanrooms, ensuring high standards of air purification, interpreting regulations, developing cleaning methods, and more. These efforts save time, reduce contamination risks, and support informed decision-making. We also develop quality documents such as user requirements and procedures, and implement training programs to enable client staff to perform tasks efficiently and safely.
An essential aspect of pharmaceutical production and operation involves ensuring reproducibility through documented processes. This necessitates meticulous management of information and documents, including certificates, user manuals, test results, work procedures, risk analyses, change management, qualification and validation reports, and more.
We excel in keeping information up to date, well-organised, and audit-ready, ensuring operational efficiency and compliance.
Implementation of Technological Processes
The rapidly evolving technologies related to production in cleanrooms continually offer opportunities for improvement, but also necessitate staying updated with sector changes. Our experts play a crucial role in advising on and implementing various systems essential for managing a cleanroom environment: environmental monitoring, HVAC, isolators, biosafety cabinets, automatic decontamination, and more. We provide support for procurement, commissioning, and validation processes.
Sector-Specific Knowledge of PIC/S Standards
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) sets international regulations for inspection procedures in the pharmaceutical industry. Implementing PIC/S standards in hospitals and healthcare facilities positively impacts quality maintenance and safety in pharmaceutical activities within the healthcare sector.
While the implementation of PIC/S standards can have a significant impact, the process itself is relatively new and challenging for many stakeholders. Therefore, our experts assist hospitals in preparing for and implementing PIC/S standards, as well as provide training and education for hospital staff. We help hospitals review existing processes to ensure compliance with international PIC/S standards, contributing to continuous improvement in quality and safety.
Collaborating with Stakeholders in Healthcare
Depending on the projects our experts engage in, we collaborate with various contacts within hospitals, laboratories, or pharmacies.
Pharmacists in Hospitals or Pharmacies
Often, it's the chief or industry pharmacists who appreciate our added value. They understand the quality requirements certain processes demand, but often find it challenging to stay updated on all required innovations and industry advancements. An independent expert can provide them with high-quality advice.
Laboratory staff
Quality control and management often begin in the laboratory. We provide support in Quality Control and Quality Assurance to deliver the highest product quality. Our experts are well-versed in laboratory environments, fostering successful collaborations with hospital laboratory managers.
Department heads and operational managers
Validating processes, equipment, and optimising projects are daily concerns for operational managers and department heads in hospitals. They frequently recognise the value of an independent partner for additional expertise.