TRAINING AND EVENT MANAGEMENT SYSTEM REQUIREMENTSWe have added the required feature and process flow in the flowchart as yellow highlighted. Now the required features can be described as below:1. USER CATEGORY AND ROLE:a. HR AdminThis type of users will be able to I. Add/delete/edit employee info.II. Plan for orientation training schedule.

b. Trainer (Only Authorized personnel and who has SAP user ID)This type of users will be able to I. Plan and scheduling for training and changeII. Upload training material like power point slide or videoIII. Conduct training and make evaluation of Exam.

c. Training coordinator (In every department one person will be assigned as) This type of users will be able to I. Yearly training plan for own departmentII. Add retraining requirement for employees and uploadIII. Other tasks like trainer

d. Training Manager/Training Admin (One person from QA department like Mr. Habibur Rahman)This user will be able to I. Upload training document like SOP/EOP/ECP/GMP module and set training requirement group as stated in SOP/EOP/ECP.II. Review yearly training planIII. Review competency certificateIV. Other tasks like training coordinator

e. Head of Department (HOD)-Every Head of departmentThis user will be able to I. Check yearly training planII. Employee Transfer/Job rotationIII. Assign employee to specific workstation as and when requiredIV. Issue competency certificate V. Other tasks like training coordinator

f. QA ManagerThis user will be able to I. Approve orientation, yearly training plan.II. Approve competency certificateIII. Other tasks like HOD and training manager

2. PROCESS FLOW DESCRIPTION:As per the process flow attached herewith there are some requirements (yellow highlighted).a. JOB profile: This is to be designed as per employee group and work role or responsibility. Say, for dispensing personnel role will not be same as cleaner. All the probable role profile will be considered as Master Data.

b. Authorized trainers List: There must be a system to authorize as SOP/EOP/ECP trainer and GMP module trainer. This may be experiential or formal approach. This approval role may be given to QA manager.

c. Employee Post training evaluation: There must be a skill matrix based system for post training evaluation and subsequently to issue competency certificate. There must be a master data for probable skill matrix for various department.

d. On the job monitoring: There must be a system for on the job monitoring and assessment. If there is any problem (SOP noncompliance, knowledge gap etc.) found with employee during assessment, action may be taken as retraining/counseling, job change, skill level down grade, administrative action.

e. Document (SOP/EOP/ECP) and GMP module: There must be a system to input issue date, effective date, review due and endorsement date for documents as applicable.

f. Training needs assessment: Retraining may be triggered from quality incident, absenteeism, failure in exam., and any others. All the issues to be considered.

g. Employee transfer: There must be a system to transfer/job rotation of employee. This may be company to company, plant to plant, department to department, section to section, workstation to workstation and also job profile change. In these cases there must be an automated system to generate training requirement list.

h. Notification system: Notification system for upcoming training event, training absenteeism, failure in exam., training needs requirement etc. This notification system can be limited to HOD, Training manager, QA manager and trainer.

i. Training plan and schedule: Yearly training plan (phase wise-3 phases) to be done by every department coordinator, reviewed by HOD, training manager and approved by QA manager. Scheduling to be done by multiple session wise to cover all listed group training.

a. Dashboard: There can be a dashboard system to show ongoing training event and upcoming training event.

3. REPORTS:b. Yearly Training plan for every departmentc. Training schedule and sessions with participants name, ID, designation, venue, date time and training material reference number.d. Training attendees by training document number as per our existing SOPe. Training absentees list by training document number as per our existing SOPf. Training evaluation report by training document numberg. Skill level matrix by company, plant, department, section, workstationh. Skilled person list with level by company, plant, department, section, workstation.i. All the skill assessment forms for machines, jobs j. Individual training plan for every employee phase wise as per our SOPk. Training summary for every employee as per our SOP. If there is any job rotation event found for particular employee gross report to be generated.l. Employee job rotation/ transfer historym. Audit trail report as per 21 CFR part-11n. Training needs assessment report at any time by Document number, department, section and workstation.