An effective Clinical Quality Management System (QMS)
It'sQA can help manage your company's QMS by preparation of Standard Operating Procedures (SOPs) to assure compliance with GCP requirements.
A QMS is necessary in order to comply with GCP, pharmacovigilance regulations, GLP and GMP and for validating computer systems. An effective quality management system is also essential for your business.
It'sQA has many services, which can be tailored to the specific requirements of your company, and will act as your own independent QA department perfectly integrated with you, your clients and inspectors.
Working in partnership with It'sQA, your company will be ready for audits and inspections at any time. We work with you to determine the most cost-effective solutions and can provide a variety of QMS services, such as:
- Management of the Corrective and Preventative Actions (CAPA) system
- Categorisation and metrics of issues
- Audit follow-up (responses from auditees)
- Optimisation of existing QMSs
- Gap Analysis and preparation for regulatory inspection
- Advice and preparation of SOPs to assure compliance with GCP requirements
- Additional support for QA units to meet short-term needs at times of overloading
- Advice on general issues relating to GCP, risk management and so on.
Confidentiality is assured at all times and you will appreciate that we offer a highly competitive cost/value packages.
Talk to us, to discover our range of services and let us manage your QMS requirements for you.