An effective Quality Management System (QMS) for Drug Development and for Clinical Research
It'sQA can help develop and manage your Company's QMS by preparation of Standard Operating Procedures (SOPs) to assure compliance with GxP requirements including GCP, GMP, GLP and GVP.
A QMS is necessary to comply with GCP, GVP, GLP and GMP regulations and for validating computer systems. An effective QMS 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, suppliers and inspectors.
Working in partnership with It'sQA, your company will be continuously ready for audits and inspections. 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 overload
- Advice on general issues relating to QA GCP, GLP, GMP, GVP, Risk Management and Auditing.
Confidentiality is assured, and you will appreciate that we offer highly competitive and cost-effective packages.
Contact us to discover our range of services, and let us manage your QMS requirements for you.