Document Control System has been designed to control the recordable formats like Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Log Books and other loose formats to be used in various departments.
Word Format of Documents is uploaded in the system, Review and Approval of Documents is done electronically with E Signature. Approved documents enter the cycle of Document Request and Issuance.
Log Book Stock and Location Management.
Retrieved Document store in Hard copy and Scanned format.
Document Control System has been designed to control the recordable formats like Batch Manufacturing Records (BMR), Batch Packing Records (BPR), Log Books and other loose formats to be used in various departments.
Scanned Copies of Approved Documents in PDF Format are uploaded in the system for Document Request and Issuance.
Log Book Stock and Location Management.
Retrieved Document store in Hard copy and Scanned format.
This System calculates the MACO (Maximum Allowable Carry Over) limit after making the cleaning Validation Matrix using the following three Criteria:
Dose Criteria
10 PPM Criteria
Visual Criteria
This system has been designed to help the users to do the predefined calculations of Quality Control Lab under the regulatory environment.
This system has advantage over the simply validated excel sheet in the sense that this system for excel sheet validation complies to USFDA CFR 21 Part 11
SOP Management System has been designed to control the SOP’s of all the departments in the plant.
Word Format of SOP is uploaded in the system, Review and Approval of SOP is done electronically with E Signature. Approved SOP enters the cycle of SOP Request and Issuance.
Training Management system has been designed to handle Trainings of Employees it may be Induction Training, cGMP Training, SOP Trainings, general trainings, Need identified trainings and external trainings.
System enables the user to go for electronic testing, where training evaluation is performed by system.
Equipment Management System has been designed to schedule, track and close the predefined requirements like Calibration, URS, DQ, PO, FAT, SAT, IQ, OQ, and PQ of the Equipments and their sub parts like Temperature sensors and pressure Gauges.
Requirement/Activity Tracking System has been designed to schedule, track and close the predefined requirements/activities.
System keeps track of happening the event of prescheduled requirement/activity and alerts the responsible persons through mails about the happening of event.
Alerts continue till activity/requirement is closed in the system with proper uploading of related documents.
If Activity is of re-occurrence nature then next run of the activity is auto scheduled by the system with predefined frequency of re-occurrence.
Document library system has been designed to handle the executed documents in PDF form as well as in Hard Copy form in documentation cell.
Any document present in the documentation cell is issued to the user after the proper requst by the user.
Document is issued only if the User request for hard copy or soft copy gets approved by respective HOD and QA.
Location management of the executed documents is performed by the system.