Build robust Quality management systems (QMS) tailored to any regulatory compliance strategy with fast turnaround time.
Analyze procedures based on client and product-specific requirements and develop/ review customized standard operating procedures (SOPs).
Implement virtual document control and record management for effective and traceable deployment of Quality systems
Integrate QMS to incorporate all elements of QC/QA/ manufacturing such as SOPs, policies, deviations, change control, out-of-specifications, CAPA, audits, training etc. in one place for increased productivity and efficiency.
Build a calibration and preventative maintenance program including review of calibration data for all equipment.
Develop validation protocols for qualifying rooms and equipment (IQ, OQ, PQ) used in GMP manufacturing.
21 CFR Part 11 System compliance assessments and training, including electronic signatures and data integrity.
Adherence to 21 CFR 210, 21 CFR 211, 21 CFR Part 820, ICH guidelines, FDA guidelines, GAMP 5, good manufacturing practices (GMP), good laboratory practices (GLP), good documentation practices (GDP) .
Adherence of Quality management systems to ISO 13485 and ISO 9001.
Remediation support in response to FDA 483s and warning letters and develop effective Corrective and preventive action (CAPA).
Develop vendor qualification program and assist in qualifying vendors for use in GMP manufacturing.
Develop and maintain inventory control program and database for raw materials, intermediates and final products used in manufacturing/ testing.
Review documentation related to QC/ QA/ manufacturing like batch records, material specifications, testing, deviations, change control, out-of-specifications etc.
Get in touch with us
At Sasaur Consultancy, we are committed to fostering enduring partnerships with our clients, delivering outstanding service at every stage of our collaboration.
