List of QA SOPs


The quality assurance department at DMRI is dedicated in enhancing and ensuring the quality of all systems & procedures in an effective & efficient manner.

An independent QA department monitors and reviews the effectiveness of DMRI’s quality assurance policies & procedures.

The QA department comprise of a team of experts with a high degree of experience, integrity and work ethics.

Responsibilities:
  • Preparation of Quality Manual and Quality Policy.
  • Implementation of systems and procedures as per ICH - GCP and GLP guidelines.
  • Preparation and implementation of SOPs.
  • Training schedules of personnel.
  • Calibration schedule for equipments.
  • Monitoring on-line quality control of systems and procedures.
  • Internal / External audits.
  • Talent search.
  • Environmental protection
  • Archival

DOCUMENTATION, STATISTICS, REPORTING, ARCHIVAL, etc.

D.M.R.I. has separate data-processing sections for clinical documentation, writing protocols and making reports.

D.M.R.I. has an in-house bio-statistician using the latest versions of software (SAS, WinNonlin, etc) which is internationally accepted and enables preparation of flawless, accurate reports.

Archival facility: Complete data management / archival as per sponsors’ / regulatory requirements.

D.M.R.I. has a separate administration department which looks after human resources, purchase, finance and also environmental protection including bio-waste management.
 
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