Medical Affairs

Quality Assurance

Quality is our cornerstone—and is at the heart of everything we do.

At Diligent, Quality Assurance is not a person or department; it is everyone’s responsibility. We know that quality is of paramount importance in the pharmaceutical and biotech industries and must be reflected, in equal measure, in all aspects of our work.

Our Quality Policy is based on 21 CFR Part 820. It addresses:

  • Document management principles including document hierarchy and the management of GxP Controlled Documents such as Policies, Standard Operating Procedures and Work Instructions. Essential GxP functions are performed efficiently, consistently, and in a manner compliant with regulatory requirements.
  • In-depth and multi-faceted initial and ongoing training, including assessments and certifications. All training is documented and easily accessible for review.
  • Internal audit procedures to ensure we are continuously measuring ourselves and raising the standards of performance.
  • Supplier/vendor management and audit procedures to ensure our partners perform work to expected standards.
  • Robust procedures surrounding Change Control, Deviations and CAPAs, ensuring we are effectively managing your business and learning from every opportunity.

We leverage the e-QMS platform Q-Pulse to meet the Quality System requirements of 21 CFR Part 820. Q-Pulse functionality includes the management of:

  • Controlled Documents such as SOPs, Policies, and Work Instructions
  • Training curriculums and records
  • Audit schedules and reports
  • Supplier qualification
  • Deviations and CAPAs

We conduct an annual evaluation of the processes and methodologies in our Quality Policy—and make any needed changes—so that it continues to achieve its objective of ensuring our commitment to quality matches that of our clients.

We also offer AI Conversation intelligence, which identifies types of calls that require more scrutiny based on measurable call elements that include talk to listen ratios, average talking speed, and average pause. The technology also measures the sentiment of the caller/callee (positive, negative, neutral) and the use of identified key words and phrases. Over time, best practices can be refined based on these measurements, and coaching/training opportunities identified.

Additional Medical Affairs Services