Pharma Enterprise Quality Management Software & FDA Quality Metrics

Organizations that manufacture products within a GxP or Regulated environment are required to deliver quality consistently. These companies adopt a Pharmaceutical Quality Management System that ensures Assurance and Control on Quality consistently. But with stringent regulations, growing customer demands and to make a global presence, there is a natural need for the Quality Management System to be robust, effective and efficient.

AmpleLogic Biotechnology and Pharmaceutical QMS Software , A pre-configured Smart Quality Management System that comprises of 13 modules like CAPA Tracking, Change control, Deviations, Training etc. with powerful automation and intelligent tracking.

AmpleLogic Pharma QMS, a software and CGMP Quality Management Solution enables organization to automate their paper-based Business Processes and integrate them across a single platform. This brings an exceptional transparency across Quality Systems and in resolving quality issues down their roots. The system has been developed to be flexible in adapting quickly with compliance to regulatory standards and be diverse across a wide range of customers, maximizing benefits of reducing the Quality Costs.

Why our Pharma QMS Automations Solutions Stand out?

Ample Logic Quality Management went through an extensive research in developing solution to be practical and problem oriented.

  • 24 × 7 global accessibility that allows managing quality issues round the clock
  • 21 CFR Part 11 Complaint.
  • Clear Transparency and in-depth traceability across integrated Quality Systems, Web based Access.
  • Flexible QMS architecture that allows seamless integration with SAP, HR etc.. , Ability to Customize Reports.
  • Best practiced workflows that allows improved closure timelines and reduced initiation timelines
  • Centralized Data Repository that provides harmonized data management across an Organization
  • Metrics Reporting and Analytical Trending that provide informational reports with eye catching visual representation
  • Customizable workflows to suit the needs of Business Process
  • Notification and Reporting capabilities to Customer/ Regulatory at defined workflows steps for appropriate reviews and approval

FDA Quality Metrics

Quality metrics is the key to measure the process and quality in the Pharmaceutical, drugs (API and chemical) and biologics. This helps to continuous improvement efforts in drug manufacturing. FDA will accept voluntarily submissions of data from owners and operators of human drug establishments.

FDA recently revised draft guidance includes how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and the intention to utilize submitted data and quality metrics.

FDA’s proposed requests is maintained in accordance with 21 CFR Part 11 based on there areas of business namely, finished dosage forms, dosage form products and Active Pharmaceutical Ingredients (API’s).

Amplelogic QMS allows in regulatory readiness by providing automated Quality metrics for each module namely CAPA, Deviation, Change Control, Market Complaints, Supply chain, OOS and OOT against their KPI Indexes.

Amplelogic Quality Metrics helps tracking the following

  • Stability Productivity
  • Market Complaints and Lot Returns
  • OOS Root cause and invalidated OOS
  • Lot disposition
  • Deviation closed and Overdue
  • Raw Material Release Cycles and Intermediates Release cycles
  • Audit Scheduled and Repetitive findings
  • Productivity details of Raw material, finished product, Intermediates and Microbiology
  • Regulatory Inspection and the Response timelines
  • Customer Inspection and the Response timelines

When the organizations are not ready for an automated QMS, Amplelogic offers an intermediate solution which is Excel base, allows to fill in the information specific to the process area that helps in generating Quality metrics as per the Regulatory Requirement along with 21CFR Compliance

Amplelogic QMS Modules trusted by 8 customers. Our QMS automation Solutions were Implemented at 6 USFDA Approved Units and 2 MHRA approved Units. Currently 2 implementations are going in WHO approved Units too.

Modules under our Pharmaceutical Quality Management Software are