We understand the complexities and constant changes in the pharmaceutical industry. Therefore, we work closely with our customers to provide customized QA solutions.
Our priority is to identify risks and improve processes to ensure product quality and regulatory compliance.
At Farma Consulting & Partners, we can manage the complete organization of your quality processes. We ensure that all regulatory requirements are translated into a lean quality system.
We also offer advice to optimize existing quality processes, or to temporarily take over quality management tasks in your company.
We have a team of experienced Qualified Persons, ready to support you. We offer several options, such as integrally fulfilling the role of QP within your company, or just providing support for release activities. With our experience with inspections and regulatory processes, we can help you maintain the quality oversight appropriately.
Our experienced auditors are ready to support you in conducting objective and independent audits that meet regulatory requirements and industry standards. Whether it concerns internal audits to check your own processes and systems, or audits to qualify suppliers and ensure the reliability of their products and services, we provide the necessary support.
Validation & Qualification
Through our qualification services, you can be confident that your equipment and facilities meet applicable regulations and quality standards. We guide you through every step, as from defining qualification protocols to conducting qualification tests and setting up detailed reports. Whether you need support duirng installation qualification (IQ), operational qualification (OQ) or performance qualification (PQ), our team is ready to deliver accurate and reliable results.
Our computerized system validation (CSV) experts work closely with your organization to determine the appropriate validation strategy based on system complexity and risk. We conduct thorough impact analyses, identify critical system functions, and validate data integrity, accuracy and reliability of the data. We also ensure that your CSV operations comply with applicable regulations, such as FDA 21 CFR Part 11 and EU GMP Annex 11.
With our comprehensive quality assurance and quality management services, we provide valuable support to manufacturers and developers of medical devices. Our experienced team helps you develop and implement effective quality management systems that comply with international standards and regulations, such as ISO 13485:2016 and the Medical Device Regulation (MDR). We understand the complexities of the medical industry and ensure that your organization meets the strictest quality standards.
Are you interested in our services or would you like a customized proposal?
Contact us directly using the form below!