Electronic Logbook (eLogbook) Software for Pharmaceuticals
AmpleLogic Electronic Logbook is a web-based software or platform that records general production requirements and keeps track of Area and Equipment operational usage, Packing, Cleaning, Break Down, Clearance, and Preventive Maintenance, Fogging and Defogging Logs, Granulation, Calibration, Equipment Usage, Stability Schedule, Standards Usage, Service Logs, Dispensing, Production, Chemical Usage Logs, and many other equipment details log.
This eLogbook Software is designed to assist users in converting manual paper forms to electronic equivalents. Additionally, the logbook software guarantees that details or logs are entered accurately and on time, and that they may be validated, reviewed, and authorized via approval workflows.
AmpleLogic Equipment Usage Logbook Software is compliant with FDA regulations governing electronic records and signatures, including 21 CFR Part 11. This solution also complies with other regulatory standards such as EU Annex 11, MHRA, GAMP, Good Manufacturing Practice (GMP), Standard Operating Procedures (SOP’s), and ISO. The software was created having in mind the requirements of major regulatory authorities, and to better serve our clients
The AmpleLogic eLogbook Software/Electronic Logbook guarantees that information is disseminated throughout the organization’s essential operational departments including the quality, production, planning, and maintenance departments; and they serve to bring clarity and transparency to the entire organization’s production and QC lab activities.
AmpleLogic’s Electronic Logbook Software helps in configuration of different types of logbooks.
Area and Equipment Logbooks
|Equipment Usage logs||Boiler Operation logs|
|Environment Condition||HPLC Usage logs|
|Calibration Logs||AHU Parameter Monitoring|
|Chiller Operation logs||HEPA Filter Replacement|
|Purified Water Distribution||Air Compressor Monitoring|
|Semi-Micro Balance logs||TDS Analyzer logs|
|Pressure Monitoring||Melting Point Apparatus|
|Electrical Substation Operation||Maintenance logs|
Quality Control Logbooks
|Sample Registration logs||Stability Protocol logs|
|Chemical initiation logs||Chemical Booking logs|
|Sample Management logs||Standard logs|
|Impurity Standard logs||Working standard logs|
|Reference Standard logs||Laboratory standard logs|
|Column Usage logs||Incubation logs|
|Experiment template logs||Sample Withdrawal logs|
|Pilot experiment logs||GC Usage logs|
|Document Issuance logs||Quality observation logs|
|Request Issuance, Retrieval logs||Extension request for OOC logs|
|Training Material Issuance||Batch Detail logs|
|Training attendance logs||Packing Material logs|
Cleaning and Sanitation Logbooks
|Weekly Drain Point sanitation||Accessories cleaning Logs|
|In-Process Container Cleaning||Sequential Logs|
|Portable equipment logs||Daily cleaning or sanitation|