QUALITY MANAGEMENT SYSTEMS

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 Ask Solutions provide wide rage of services in Quality Assurance, Quality Control documentation review and provide clients better compliance as per the GXP and regulatory compliance requirements.

 Help in writing all functional departments like Quality Assurance, Quality Control, Facilities & Engineering, safety, Regulatory, warehousing & Material management, DEA standard operating procedures per client requirements. 

Help the clients with all the quality management systems like change controls, deviations, corrective actions and preventive actions, quality metrics by using various QMS tools, conduct risk assessments by using FMEA/FMECA (Failure Mode Effect Analysis & Failure Mode Effect and Criticality analysis).

Help the clients with product quality complaint handling, SOP, complaint investigation writing, complaint closures. 

Help the clients for the preparation of Annual product quality review SOP, report template creation, cover all aspects of the product critical process parameters (CPPs), critical quality attributes (CQAs), quality trend analysis,  sigma CPK statistical evaluation procedures and trend analysis covered as part of APRs.

Help the clients in batch records review and releases, SOP writing, provide end to end services to make sure the each and every product lot have been reviewed and released asper the compliance requirements.

Help the clients quality agreement writing, service agreement writing between the parties for their quality or various services like testing laboratory, CMO, CPO, suppliers and distributor agreements based on the client needs and business scenarios.