Rhumbline Consultancy supports and facilitates in all processes of the supply chain of manufacturers, laboratories, suppliers and service companies operating in the pharmaceutical and medical industry and Life Sciences.
A detailed description of the services can be found below.
Reaching the goal within agreed budgets and timeframes is the basic of good project management.
Project Management can be delivered in all phases of the process. Start-up and initiation of the project, active management of the project and completion of unfinished projects can be performed by Rhumbline Consultancy.
Experience with the maintaining the focus on the main issue in combination with knowledge of current regulations and guidelines makes Rhumbline Consultancy a valuable resource for the execution of project management.
The following examples of project management can be considered:
A combination of knowledge, experience and personal behaviour is required for the coordination and support of production activities, optimisation of business processes and restructuring of departments. This combination is available at Rhumbline Consultancy and is provided to our customers based on the customer-specific request.
Exceptional good results are obtained by the pragmatic and efficient method of Rhumbline Consultancy in the area of improving the quality, increasing the output and making processes more efficient.
Examples of production management are:
We offer services for the establishment, maintenance and improvement of Quality Management Systems according to various guidelines, e.g. GMP, CFR, ISO 9001 and ISO 13485
The patient always plays the main role in all decisions. Absolutely no concession on the quality of the product is allowed when working with patients and products intended for patient use.
Knowledge of current guidelines and the implementation of guidelines can have a huge impact on the efficiency of the organisation. Our practical and effective way of working in combination with the experience of implementation of the guidelines makes us able to establish your systems with the correct level of quality and at the same time improve the efficiency of the organisation.
Examples of Quality management are:
Within the Pharmaceutical, Medical and Life sciences industry it is required to have knowledge of project management, processes and quality standards to be able to coordinate method- and production transfers.
We support in all phases of the site transfer. If requested, Rhumbline Consultancy can coordinate the total site transfer. The network of Rhumbline Consultancy contains fully certified laboratories and suppliers.
Quality Control is directly linked to the production process. What specifications are drafted, what inspections are implemented as part of the incoming inspection, in process inspection and final inspection? What tests are being performed, what analytics? Which critical parameters are evaluated as part of validations and which critical parameters are tested on batch-level? En most important: why? In most organisations, answering al these questions results in a long discussion. Evaluation of the individual risks by means of a Risk analysis is a method often used. Rhumbline Consultancy supports with the implementation of inspections based on the customer request independently. The quality of the product is most important. Implementation of the inspections is performed in such a way that fit’s the company’s methods and culture.
Every organisation should have a critical focus on the business processes to be able to identify potential improvements. In addition to the requirement of performing internal audits, an internal audit is an effective preparation for an external audit performed by the government, a Notified Body or a customer.
Building up required and necessary experience of an internal auditor is mostly a difficult process and might request for conflicting interests. In addition, execution of internal audits and external audits increases the workload of the own personnel.
Rhumbline Consultancy can perform internal and external audits for you. We have wide experience in preparation, execution, reporting and follow-up of internal and external audits.
We have build up our external auditing experience by performing audits at manufacturers of medicinal products, suppliers of raw materials and packaging materials, sterilisation servicing companies and various laboratories.
Quality in Research & Design
When starting up a company or when designing and implementation of a new product or process, the initial focus is not on quality aspects.
We can calculate for you what you might save when implementing quality assurance and quality control in an early stage. Implementation of GMP aspects in an early stage has a lot of benefits. In addition, up scaling from pilot production to regular production can take place without mayor adjustments of the quality implementations.
Every process is unique. Therefore we deliver customer specific quality services.
Services in the field of Safety, Health & Environmental (SHE) are provided by Rhumbline Consultancy as well We can support the role of the Occupational Health and Safety Coordinator by establishing, reviewing and maintaining the RIE. We can play a key role as contact person between your company and the various governmental departments. Rhumbline Consultancy can perform the process of establishing, acquiring and maintaining Environmental Licences. We can play a key role as contact person between your company and the various governmental departments.