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Quality management system
This document describes various quality management system modules provided by AmpleLogic, including CAPA, change control, deviation management, audit management, vendor qualification, and market complaints. For each module, it discusses regulatory requirements, problems with traditional manual systems, and key features of AmpleLogic's computerized solutions. The solutions provide features like electronic records, signatures and audit trails, integration between modules, and automated notifications and reports. AmpleLogic is an established quality management software provider that works with many global pharmaceutical companies.
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Quality management system
- 2. AMPLELOGIC QUALITY MANAGEMENTSYSTEM CAPA Change Control Deviation Market Complaints Vendor Qualification Audit Management OOS / OOT QUALITY MANANGEMENT MODULES Integrated Modules 21 CFR PART 11 Compliance Web Based Solution
- 3. QMS MODULE -CAPA PROBLEM STATEMENT Regulatory Requirement (FDA) CAPA MODULE The purpose of the corrective and preventive action system is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence FDA has published “Guide To Inspections of Quality Systems” (often referred to as “QSIT”) where they tell you how they will conduct an inspection. Extensive follow-up is required to determine status and ensure the CAPA is progressing The process is difficult to execute consistently due to a lack of control Incomplete forms and/or mistakes in completing the forms Reporting and analysis is very labor intensive Difficult to determine the bottlenecks in the process Lack of accountability from employees due to lack of management visibility Delay in closures because there is no proper navigation of tasks and no stringent follow ups in manual process As all the task are defined by TCD, there is no proper notification, reminder or escalation process in manual activity which delays the planned action No proper collaboration between cross functional teams Lack of expertise to determine the definition of CAPA and Root Cause
- 4. QMS Module -CAPA APPROACH TO CREATING A RISK BASED CAPA PROCESS AmpleLogic CAPA Tracking Software investigates systems intricately in order to find errors and problems. This software also helps in solving these problems by identifying them and taking necessary corrective measures to prevent any future re-occurrence 21 3 54 6 87 9 1110 12 1413 15 INQUIRY AND ASSESSMENT PRE-INVESTIGATION INVESTIGATION PLANNING AND EXECUTION REVIEW AND VERIFICATION Create CAPA request and submit for review. Identify sources of CAPA worthy issue Review CAPA request. Determine whether or not issue requires CAPA investigation Accept or reject CAPA request If accepted, issue and initiate CAPA Finalize CAPA sources (i.e., products, processes) Determine CAPA cross-functional team Identify any immediate actions and corrections required Investigate and capture findings Determine root cause(s) Specify corrective and/or preventive action plan Complete action plan Review CAPA for completeness Approve CAPA actions Specify steps for effectiveness verification Verify effectiveness of CAPA 1 2 3 4 5 6 7 8 9 10 12 11 13 14 15
- 5. QMS MODULE -CAPA CAPA Integrated with other QMS modules KEY FEATURES Create CAPAs and link to root cause Route Investigation & CAPA plan for approvals Track completion and verification of each CAPA Measure effectiveness according to the plan Automated CAPA process Easy distribution of task Automated Email Alerts, Notifications, Reminders and Escalations Complete Traceability with E-signatures, audit trails and Log activity information 21 CFR Part 11 and EU Annex 11 Compliant Configure to meet your internal processes or requirements Built in reports, graphs and analytical tools
- 6. QMS MODULE –CHANGE CONTROL Material (Raw & Packaging Material) Production Engineering Changes Reported by Change Management Process Research & Development Quality Control Quality Assurance Information Technology Cleaning Procedure Poor Turnaround for change implementation, as company relying on manual system require more time and effort to route and check submissions and change orders. Lack of communication between departments, failure to follow up or escalate change request Not having flexibility to adapt according to the dynamic changes of regulatory bodies. Ineffective documentation as in manual process it is more difficult to find/ retrieve necessary data, update document to support the change. Training not integrated with Change No integration between the other modules of QMS PROBLEM STATEMENTRegulatory Requirement (FDA) All changes should be made according to approved (approval implies successful testing or through review/ investigation) written company policies and procedures. Any change in the production and processes must be controlled meaning recorded, reviewed and approved by the QC unit.
- 7. QMS MODULE –CHANGE CONTROL Guideline for the Establishment of a Change Control Procedure Change Request Initiation Change Request Evaluation Change Control Committee (CCC) Evaluation Change Request Approval Change Implementation Review and Verification Close Change and Effectiveness Check Features of AmpleLogic Change Control Management Software Structured and consistent approach towards managing change Documentation of change approvals and implementation Documenting the details of change Impact Analysis of the Change Control Record Checklist for Impact Assessment of Changes Post Change and Effectiveness monitoring of change Complete Traceability with E-signatures, audit trails and Log activity information 21 CFR Part 11 and EU Annex 11 Compliant Configure to meet your internal processes or requirements Built in reports, graphs and analytical tools Seamless Integration to Document Management, Learning Management and other QMS Modules Automated Email Alerts, Notifications, Reminders and Escalations
- 8. QMS MODULE –DEVIATION MANAGEMENT PROBLEM STATEMENT Paper based system can result in excessive downtime and poor turnaround in identifying, resolving deviations. REGULATORY REQUIREMENT (FDA) Critical deviations should be investigated, the investigation and its conclusion should be documented Written procedures should be established and followed for investigating critical deviations or the failure of batch of immediate or API to meet specifications. Any deviation from established procedures should be documented and explained. Deviations from approved standards of calibration or critical instruments should be investigated to determine if these could have an impact on the quality of the intermediate or API manufactured TYPES OF DEVIATION PLANNED DEVIATION UNPLANNED DEVIATION Poor deviation tracking during the course of a product development Difficult to look for trends as there can be multiple variables involved in the occurrence of a single deviation Paper based systems are inherently time-consuming and it can significantly hamper in their efforts to respond effectively on the multiple levels. Difficult to track action plans and assigned tasks to address issues and raised CAPAs Ineffective risk analysis and investigation which can result in unidentified risks for users, customers, employees, the organization. Lack of data visibility among quality and regulatory team members to consider the impact on other batches
- 9. Initiate Quality RiskManagement Risk Identification Risk Analysis Risk Evaluation Risk Assessment Risk Reduction Risk Acceptance Risk Control Review Events Risk Review Result of Quality Risk Management RISKCOMMUNICATION Identify Immediate actions / corrections Event Detection Complete Initial DetailsRaise Deviation Deviation Categorization Minor Major Critical Root Cause Investigation Identify Corrective and Preventive Actions (CAPA) Close Access Risk Effectiveness Check QMS MODULE – DEVIATION MANAGEMENT 5 WHY FLOW CHART FACTOR ANALYSIS TREE DIAGRAM FISHBONE DIAGRAM PARETO CHART
- 10. QMS MODULE –DEVIATION MANAGEMENT Features of AmpleLogic Deviation Management Complete Traceability with E-signatures, audit trails and Log activity information 21 CFR Part 11 and EU Annex 11 Compliant Built in reports, graphs and analytical tools Seamless Integration to other QMS Modules Automated Email Alerts, Notifications, Reminders and Escalations DEVIATION HANDLING ROOT CAUSE INVESTIGATION RISK MANAGEMENT Record Deviation details & affected areas/ process Record investigation details & action plan for risk mitigation Built-in root cause analysis tools Product or Batch impact mapping Linking with repeated deviations based on company workflow Monitor deviation status & closure Dynamic deviation reports to check the dependency
- 11. QMS MODULE –AUDIT MANAGEMENT Inefficient scheduling as manual methods and spreadsheet are at disadvantage when scheduling audit calendar and notifying concerned departments on the schedule. Traceability and archiving of past audit reports. Difficulty in audit collation as audit is conducted within different segment of the organization and each area of operation has its risks and challenges. Missing Audit Observations and Findings Compromised security in ensuring confidentiality and limited distribution of audit reports PROBLEM STATEMENT
- 12. Pre-Audit Process & Activity Audit Planning and AuditPreparation Audit Initiation Audit Schedule acceptance by Auditor and Auditee Audit Confirmation / Publish Develop an Audit Plan Prepare Pre-Audit Questionnaire Review Background Information Review Operational Information Develop On-site Questionnaire and Audit Protocols Select Departments for communication On-Site Process & Activity Post Audit Process & Activity Audit Observation Recording Audit Response Recording Document Review Detailed Site Inspection Review Audit Evidence Audit Findings and HOD review Audit finding acted upon (CAPA & Tracking) Audit Finding action item implementation review Audit Findings Closure Audit Closure Collate Information and follow up Prepare the Audit Report Circulate Draft Audit Report for Comments Audit Compliance Report TYPES OF AUDIT QMS MODULE – AUDIT MANAGEMENT MASTERS CONFIGURATION Departments Division / Plant Approve Plan and Checklist Internal Audit External Audit Vendor Audit • Scheduled • Un-Scheduled Auditee Users Group Auditor Users Group Audit Calendar Audit Checklist Yearly Audit Planner Audit Certificate
- 13. QMS MODULE –AUDIT MANAGEMENT Complete Traceability with E-signatures, audit trails and Log activity information 21 CFR Part 11 and EU Annex 11 Compliant Built in reports, graphs and analytical tools Seamless Integration to other QMS Modules Automated Email Alerts, Notifications, Reminders and Escalations Features of AmpleLogic Audit Management Audit planner (Quarterly/Monthly/Yearly) and Audit Calendar serve as a useful tool for Audit scheduling Auditee can be informed about the audit schedule through automated alert and email notification While scheduling the audit the concerned departments can be communicated on the agenda of the audit Approval mechanism in the AmpleLogic Audit Management solution allows for senior management’s vigilance on the audit program AmpleLogic solution also has qualitative rating system (Minor/Major/Critical) to note the severity of audit observations A certificate for internal auditor can be generated within the solution acknowledging the competence of the auditor which is critical in performing the audit
- 14. PLANT AGREEMENTQUALITYDELIVERY RAWMATERIALHQ PROBLEM STATEMENTQUALITY MANAGEMENT SYSTEM VENDOR QUALIFICATION Manual entry of data such as material details, sample details, trial supply is subject to error Collecting and collating evaluation comments from QA/QC at different stages such as sample collection, trial supply or on vendor questionnaire becomes quite a challenge Maintaining paper based documents for Vendor like Registration form, License details, Certificate of Analysis, Material Master becomes a daunting task for purchasing department Not dealing with situations of vendor non-conformance in a timely and effective manner Identifying an effective, reliable and selection of most profitable vendors for raw materials supply The selection, qualification, approval and maintenance of suppliers of starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system
- 15. VENDOR SELECTION PROCESS PRELIMINARY ASSESSMENT Procurement Quality Assurance PRE-PURCHASE OF SAMPLES Raw Material Questionnaires SampleTesting Quality Control ANALYSIS OF PRE-PURCHASED SAMPLES PERFORMANCE STUDY QC TESTING AUDIT VENDOR APPROVAL SAMPLING OF STARTING MATERIAL QUALIFICATION AND CERITICATION OF THE VENDOR VENDOR MONITORING VENDOR RATING QUALITYASSURANCEQUALITYRISKASSESSMENT Samples Analysis Report Certify Vendor Batch Vendor Audit Final Product VendorTrial Supply QMS MODULE – VENDOR QUALIFICATION performance measurement Continuous Quality Delivery Service Assessment
- 16. QUALITY MANAGEMENT SYSTEM VENDORQUALIFICATION Material Masters Features of AmpleLogic Vendor Qualification Complete Vendor Information can be recorded into the solution and provision for uploading registration, certification and other relevant documents received from vendorsVendor Registration Vendor Re-Qualification Vendor Monitoring Vendor Investigation Vendor Questionnaire and batch sample management Integration with Audit Management AmpleLogic Vendor Qualification solution also allows for registering details of trial supply such as, Material name and category, trial supply period, observation on trial supply etc Vendor Analysis and Assessment can be done based on complete data available in the repository Quality metric tools such as Vendor Quality Score, Sample Evaluation Quality Score, and Quality Score Average
- 17. QMS MODULE –MARKET COMPLAINTS PROBLEM STATEMENT Manual Market Complaints are outdated and not flexible. Disconnect and incomplete Information Lack of Analytics Changing Regulatory Environment Inconsistent Complaint Handling
- 18. Complaint Initiation Preliminary Investigation Source of Complaint Detailsof Complainer Product Information Nature of Complaint Complaint Category Review of Complaint & Start Technical Investigation Complaint Sample Control Sample Sample Review Feedback to Customer or Complainer Detailed Investigation Out of specification (OOS) Report Complaint Closure Return or Reimbursement Corrective Actions (CAPA) Correction actions depending on the nature of complaint and its incidence Monthly Reports And Trending Previous History Review Manufacturing Record Review Packaging Record Review Analytical Record Review Stability Data Review Incident Report QMS MODULE – MARKET COMPLAINTS
- 19. QMS MODULE –MARKET COMPLAINTS Separate screens and details capture for initiation, preliminary investigation and detailed investigation Inbuilt feature to generate the investigation report and detailed investigation report Complaint categorization based on severity, probability and detectability Detailed checklist availability as a part of investigation Analyzing the dependency on other processes like stability, batch packing, batch manufacturing to name a few also 21 CFR Part 11 and EU Annex 11 Compliant Automated Email Alerts, Notifications, Reminders and Escalations AmpleLogic provides a secure and centralized platform for receiving customer complaints and storing all subsequent documentation pertaining to investigation and correction of the complaint Configure to meet your internal processes or requirements Complete Traceability with E-signatures, audit trails and Log activity information Built in reports, graphs and analytical tools Seamless Integration to other QMS Modules Features of AmpleLogic Market Complaints
- 20. REGULATORY COMPLIANCE FEATURES AmpleLogic solutions arecompliant to meet the requirements of regulatory bodies like FDA’s 21 CFR Part 11, EU Annex, MHRA etc. Audit Trial Digital / Electronic Signature Access Authentication Record Audit Copies of Records View History
- 21. QUALITY MANAGEMENT SYSTEM– INTEGRATED MODULES
- 22. Yet to Launch eQMS (Quality Management) DMS (Document Management) LMS (Learning Management) BIMS (BatchRecord Issuance) eBMR (Electronic Batch Record) DATA eLogs (Electronic Log Book) QC Planning QM (Quality Metrics)Regulatory Changes New / Update Document Training Needs Batch Master Records GMP Training Records Production Data Statistical Analysis eLogs Data Performance Indicators Samples / Stability Schedules AmpleLogic single platform solution allows easy integration between different solutions, while minimizing the cost of third-party integrations. Launched eLogs Data QMS + Training Data RIMS (Regulatory Information Management) APQR (Product Quality Review) Training Material Training Effectiveness Record Standalone computer management ERP SystemsUser Management SINGLE PLATFORM – INTEGRATED SOLUTIONS
- 23. 2010 Operations Startedin Hyderabad India 2012 First GMP Implementation of Audit Module using LOW CODE PLATFORM 2014 ISO 9001-2015 Certification Associated with 10 leading pharma companies for DMS and QMS implementations Signed up with 7 leading Pharma Companies2015 2016 Recognized by CIO review magazine and Silicon India for unique delivery models Launched QC automation modules and LMS solution 2017 Associated with 25 US FDA/MHRA/WHO approved Plants 2018 Finalist in CPHI Worldwide Awards, Entry into Egypt and UAE Markets Foundation to develop new modules like APQR, Product Recall, ANDA & DMF tracker Started working on draft Quality Metrics guidelines by USFDA 2019 US Market entry, Appreciated by 7 customers during audit on our Paperless automation 120 Young Engineers, 10,000 Sq. feet offices and 3 channel partners Road map to add more flexibility to eBMR/MES, eLogs About AmpleLogic Trusted by 35+ Pharma & 20 Non Pharma Companies across Globe
- 24. Pharmaceutical Business Process- Ready to Use Modules 16 6 6 7 17 1 2 No of Implementations Yet to Launch
- 25. WHY AMPLELOGIC? Application Components CustomizedWorkflow Role based Access User Management Organization Hierarchy Application Session Management Temporary Role Management Robust Form Creation Data Template for Migration Record Data Validation Checks No Limit for Characters in form fields Up to 300 Mb file upload Easy Import and Export of records Support Multiple Document Formats User Features Customizable Reports and Dashboards Automated Notification User Specific Calendar Schedules Reminders Adaptable to mobile & tablet Interface Electronic Signature for approvals Multi Lingual (UI) Interface Available Login & Password Polity Check Management Features User Permissions and Restrictions Alert & Escalation Management Powerful Graphical Analytical Reports Rule Enforcements Schedule Configuration Compliance Features Integration Components Integration with Active Directory Integration with other Quality Solutions Integration with ERP i.e, SAP, Oracle etc. Biometric Access & Integration Audit Trail Activity Stamp i.e, Date, time & user Two Step Authentication Record Audit View History “Our Solution are build on LOW CODE Platform providing faster implementation cycles & ease of configuration under (GAMP4, GAMP5)”
- 26. Our Customers Pharma andBiotech Non Pharma
- 27. Any Queries? Please Contactus: info@amplelogic.com Visit Us : https://amplelogic.com/ Thank You