Process monitoring and CAPA Process Monitoring and Corrective

Process monitoring and CAPA Process Monitoring and Corrective Actions & Preventive Actions Op. Ex. Works. Com A Sneash Software Initiative 1

Major Options Click on the module ICON to view slides. Op. Ex. Works – Process Monitoring and CAPA 2

Process Audits Use Pg. Dn to scroll to next slide • Audit Templates and Audit points. • Audit Non Conformities. • Non Conformities Compliance follow up • Aging analysis • Reports on Non Conformities observed and resolved Op. Ex. Works – Process Monitoring and CAPA

Process audit template and Audit Points Process audit templates are defined along with the audit points. Each audit point is defined with Owner, department, default value for the action point and other parameters. Op. Ex. Works – Process Monitoring and CAPA 4

Audit Non Conformities. Non conformities observed in each audit conducted are recorded with details of responsibility for clearing the non conformity and target date of completion. Op. Ex. Works – Process Monitoring and CAPA 5

Section Wise Pending Non Conformities. Op. Ex. Works – Process Monitoring and CAPA 6

Audit wise Pending Non Conformities. Op. Ex. Works – Process Monitoring and CAPA 7

Owner wise Pending Non Conformities Op. Ex. Works – Process Monitoring and CAPA

Audit wise Status Of Pending Non Conformities. Op. Ex. Works – Process Monitoring and CAPA 9

Owner wise Summary Status of Non Conformities. Op. Ex. Works – Process Monitoring and CAPA 10

CAPA Use Pg. Dn to scroll to next slide • CAPA registration • CAPA Lifecycle monitoring • CAPA action plan • Monitoring compliance of Pending points of CAPA Op. Ex. Works – Process Monitoring and CAPA 11

CAPA - Registration. Op. Ex. Works – Process Monitoring and CAPA 12

CAPA - Evidence. Op. Ex. Works – Process Monitoring and CAPA 13

CAPA - Potential Impact. Op. Ex. Works – Process Monitoring and CAPA 14

CAPA - Risk Assessment. Op. Ex. Works – Process Monitoring and CAPA 15

CAPA - Remedial Actions. Op. Ex. Works – Process Monitoring and CAPA 16

CAPA - Objectives. Op. Ex. Works – Process Monitoring and CAPA 17

CAPA - Investigation. Op. Ex. Works – Process Monitoring and CAPA 18

CAPA - Analysis. Op. Ex. Works – Process Monitoring and CAPA 19

CAPA - Action Plan. Op. Ex. Works – Process Monitoring and CAPA 20

CAPA - Completion. Op. Ex. Works – Process Monitoring and CAPA 21

CAPA - Summary Sheet. Op. Ex. Works – Process Monitoring and CAPA 22

CAPA - Action Plan. Op. Ex. Works – Process Monitoring and CAPA 23

CAPA - Pending Points. Op. Ex. Works – Process Monitoring and CAPA 24

Owner wise Action Points. Op. Ex. Works – Process Monitoring and CAPA 25

CAPA wise Points. Op. Ex. Works – Process Monitoring and CAPA 26

Department Wise Action Points. Op. Ex. Works – Process Monitoring and CAPA 27

Contact Us Op. Ex. Works. Com Sneash Software 107, Sai Sayaji Puja, Lane 10, Paramhansa Nagar, Krishna Colony, Paud Road, Pune -411 038. India. Web Email Phone : www. sneash. in : info@sneash. in : +91 -20 -65214639 Sneash Software 28