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Trackwise Validation - Gratisol Labs

Trackwise Validation 

TrackWise Digital QMS software is an out-of-the-box quality and compliance platform that allows you to leverage your existing investment to quickly implement a cost-effective quality management system. Manage internal, external and regulatory audits. Initiate planned or unplanned deviations. Conduct a risk assessment, find the root cause analysis, and initiate and manage CAPAs within an integrated solution.

Out-of-the-Box Quality Processes

Say goodbye to paper, fax, email, and phone. You can manage these processes from a single integrated platform. Click on any process to learn more.

  • Audit Management
  • CAPA Management
  • Change Control
  • Complaint Management
  • Document Management
  • Supplier Quality
  • Training Management

Automate Quality and Compliance ProcessesEnsure your employees adhere to company procedures and external regulations. Eliminate inefficient manual systems, improve efficiency, and speed up quality and compliance.

Validate Your System in Record Time

The solution is fully compliant with 21 CFR Part 11 including full audit trail and electronic signature functionality.  Each release includes a validation package and supporting documentation.

Enjoy a Smooth, Low Cost ImplementationThis lightweight, web-accessed solution accelerates deployment, with minimal burden on your IT department. It also eliminates the need for costly upgrades and maintenance.

Make Smarter, Faster DecisionsSelf-service dashboards and reports are available on-demand. Make informed decisions based on the most up-to-date quality event information available.

MES ably performs in multiple function areas like product life-cycle, resource scheduling, capturing the data, processes and outcomes of the manufacturing process order execution, dispatch, production analysis and downtime management.

Quality Management (QM) is an integral part of the logistics function and within the SAP system it is fully integrated with complementary components including Materials Management (MM), Plant Maintenance (PM), and Production Planning (PP). Quality management is important to the warehouse, inspecting incoming material as it arrives at the facility and for manufacturing operations, where the quality of in-process items are checked during manufacturing process and finished goods are inspected before they reach the warehouse.

Quality Management Components

The QM module covers three distinct areas of planning, notifications and inspections. The quality planning function allows your quality department to plan inspections for goods receipts from vendors and production, work in process and stock transfers. A quality notification can be used to request action to be taken by the quality department. This may be to review an internal problem, an issue with items from a vendor or a customer complaint. The quality inspection is the physical inspection using specifications defined in quality planning.

Planning

In SAP the quality inspection plans defines how an item is to be inspected. The plan also establishes how the inspection is to take place, the item characteristics to be inspected and all the required test equipment that is needed for the inspection.

The inspection plan is an important part of the QM planning process. The plan defines which characteristics of the item are to be inspected in each operation and what kind of test equipment is required for the inspection.

Notifications

The quality notification records a problem that is either identified by a customer against a product that is produced by your company, or by your company against the product of a vendor. A notification can also be raised internally to report a quality issue that has arisen on the production line or somewhere at the facility. You can assign a quality notification to an existing QM order to create a new order for the specific notification.

Inspections

A quality inspection occurs when someone in the quality department inspects an item as determined by the inspection planning functionality. An inspection is based on one or more inspection lots, where a lot is a request to inspect a specific item. Inspection lots can be created manually by a user or automatically by the SAP system. There are a number of events that can trigger an automatic inspection lot. Most inspection lots are automatically triggered by a movement of materials, such as a goods receipt or a goods issue. But other events like the creation or release of a production order, the creation of deliveries or a transfer of stock in the warehouse.

The inspection lot functionality allows an inspection of a product in the warehouse. The product can be a finished product, a raw material, or a piece of equipment that is used in the facility. When an inspection is performed the results of the inspection should be recorded for each of the inspection characteristics. The inspection lot can be accepted as being within tolerance or can be rejected if the inspection finds that the results do not reach the prescribed specification for a certain characteristic.

When the inspection is complete for the inspection lot, a usage decision can be made as to whether the material can be accepted or rejected. After the quality department has made a usage decision the inspection is technically closed.

Reporting

SAP provides a number of reports for the quality management team. The material defects report can show the number of times an item has been in a defect status. The vendor defect report shows the frequency of failed material by vendor. By examining inspection lots for goods receipts, a quality department can highlight vendors who are supplying goods that frequently fail inspection. The customer defect report shows the defects that were found on inspections for outbound deliveries. This is important as it can help get defects resolved which will improve customer satisfaction and customer service.

Who can learn?

Candidates are preferred from:
  • Life sciences (M.Pharm., B.Pharm., M.Sc.)
  • MBBS, BDS, BHMS, and BAMS
  • Anyone intrested in PLM QM
  • Quality Management consultants

Gratisol Labs has over 10 years of experience in IT Project Management and Consulting with focus on Quality Management Systems (EQMS) for the Life Sciences and Health care sector.

– Extensive experience in requirements gathering, analysis and improvement and re-engineering
of business processes, solution modelling and validation.
– Extensive experience in leading implementation teams to deliver QMSs such as TrackWise
– Experienced with quality processes: Complaints, CAPA, Deviations, Audits, Observations,
Investigations, Change Control, Training Management, Risk Assessment
– Extensive experience to integrate the Trackwise system with external system like SAP , Cast Iron, SharePoint and Lionbridge system
– TrackWise competency Building

Course Content

  • TrackWise user interface navigation
  • TrackWise terminology & concepts, e.g., workflow, states, activities, and locking
  • Record opening
  • Record progression through perform only and schedulable activities
  • Reviewing family tree of records
  • Data entry and updates
  • Identifying next steps in a record’s workflow
  • Managing user settings
  • Relating records through the use of reference records
  • Review of a record’s history via audit trails
  • Creation of scopes and queries to locate records
  • Integrated reporting using Crystal Reports and TrackWise Analytics
  • Creation and utilization of Dashboard views for more effective task management
  • Responsible in requirement gathering for Medical Device, Pharmaceuticals and CRO process flows.
  • Designing simple to complex workflows from end to end.
  • Business rules for performing activities, scheduling activities, updating fields,dynamic queries, sending notifications,sending auto reports and closing records on certain actions like closure of child records or certain states.
  • Creating Crystal Reports for the above mentioned workflows, generic reports, management reports and charts.

Gratisol Labs Team Technical Expertise:

  • TrackWise 7.x & 8.x : Installation, Configuration and Administration
  • Crystal Reports
  • Trackwise Validation
  • TrackWise WebService : Integration of TrackWise system with multiple systems e.g Sales force,SAP,Oracle Siebel using TrackWise Web Service Java\J2EE Technology : Core Java,Spring,Hibernate,Apache JMS,Tomcat,Oracle PL\SQL

    ELIGIBILITY:
    Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:

    Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.

    SELECTION PROCEDURE:
    To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:

    • Personal Interview
    • Screening And Selection Of Students

    GRATISOL LABS ADVANTAGE

    • 2 months internship available after rigorous training in Pharmacovigilance.
    • Industry based SOP’s training
    • Trainers with minimum of 7+ years of experience
    • Comprehensive teaching by Medical Doctors
    • Hands on experience on Global Safety Databases used in the Industry.
    • Total 150 hours of exposure to theory, case studies and practicals.

    OUR TEAM OF EXPERIENCED DRUG SAFETY SPECIALISTS ALSO PROVIDES THE FOLLOWING UPON SUCCESSFUL COMPLETION OF TRAINING:

    • Resume Preparation
    • Interview Preparation with real time questions and answers
    • Mock Interview Sessions
    • Communication Skills and Personality development Sessions
    • Placement Assistance
    • Placement Assurance

    Certification:

    Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

    A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry. For more information, please contact Gratisol Labs at info@gratisol.com

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