Help the client with new facility or existing facility qualifications, writing a protocols, prepare the reports, compressed gas testing, environmental monitoring, temperature mapping per client requirements and current regulatory guidance requirements.
Help the client with new equipment or existing equipment qualification protocols like IQ, OQ & PQ, report generation and evaluate the frequency of calibration and preventive maintenance requirements, cleaning checklist and equipment, room usage, cleaning log books etc. asper the client and regulatory guidance requirements.
Help the client with computer system validations asper applicable CFR, GAMP 4, GAMP 5 requirements.
Help the clients for process validations, cleaning validation SOPs writing, protocols, reports preparation, product risk assessments which useful to the organization and to meet the current regulatory requirements.
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