Electronic Logbook (eLogs) for the Pharmaceutical Industry
AmpleLogic Electronic Logbook is a web-based software or platform that records general production requirements and tracks down Area and Equipment’s 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 application primarily aids the conversion of manual paper forms into electronic versions. The logbook software also ensures that the details or logs entered are completed and recorded at the right time and they can be verified, reviewed and approved through approval workflows.
AmpleLogic eLog solution has been designed with features that comply with FDA requirements for electronic records and signatures including 21 CFR Part 11. Other regulatory standards like EU Annex 11, MHRA, GAMP, Good Manufacturing Practice (GMP), Standard Operating Procedures (SOP’s), ISO, etc. are also adhered to by this solution. Hence, it has been designed in accordance with major regulatory bodies to serve our clients better.
AmpleLogic eLogbook Software/Electronic Logbook ensures that information is dispersed across key operational departments in the organization. These key departments include quality, production, planning, and maintenance and help in bringing clarity and transparency of production and QC lab operations to the entire organization.
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 Aapparatus|
|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|
Challenges with manual paper-based logbooks
Drug manufacturing companies encounter several incessant challenges and difficulty when they make use of manual paper-based logbooks. It is difficult to record the details pertaining to the equipment calibration, stability schedules, granulation, packing, tableting, area cleaning, maintenance, weighing and dispensing, equipment usage logs with a manual paper-based method. Manual data entry in the logbook is known to reduce productivity, irrelevant information, errors, contains inaccurate estimates for production quantities, deviation, etc.
The use of the paper-based logbook is known for creating compliance issues. It also affects operational process which tends to be inaccurate while capturing the details of the individual logs with user signatures, date, time, test and product details and batch numbers. The validation process is also challenging because lot numbers of each batch are processed across multiple locations.
It is also important to review logbook entries repeatedly to ensure that these data have been accurately collated over time according to SOP procedures. The entire process becomes more tasking when the user has to use a specific logbook for each step and hence leading to an accumulation of logbooks. This has a ripple effect on the verification of documents.
Corrections are made to specific documents on the logbook. When this is done, records are kept and these records must be signed and dated by the persons concerned along with the appropriate reasons as to why the correction was made. When these records are transferred to other departments, it is difficult to trace or track them manually and this is strenuous.
To eliminate the problems faced during data entries and capturing all the usage logs details across the facilities, we at AmpleLogic designed a solution called the Electronic Logbook. This is done specifically for the FDA (GMP/cGMP) manufacturing facilities to overcome various challenges across the departments of an organization during log entries.
Key Features of AmpleLogic Electronic Logbook System(eLogs)
- 21 CFR Part 11 Compliant
- Establishing a standard for consistent log entries throughout your organization ensures that you are ready when it is time for an audit or an inspection
- It maintains Calibration, Maintenance Service Logs, Equipment Cleaning Logs, Packing Material Logs, Out of calibration investigation logs, OOS Investigation Extension and Equipment calibration logs, etc
- It also comes with a feature that maintains Area and Equipment cleaning, usage logs of Standards, Columns, Chemical, Stability Schedules, ANDA and DMF Tracking Logs, etc.
- All your log records are also presented in calendar view with the ability to know the planned, scheduled, due dates.
- Users can also create different log reports for management or compliance requirements. Reports can be viewed online, printed, or saved as a pdf, CSV, or XML file from the eLog application.
- eLog System generates reports for operational and non-operational activities including Area Usage, Equipment Usage, Checklist Issuance & Execution, Cleaning and Sanitation Logs and many more
- AmpleLogic E-Log System will send out automatic notification, escalations to ensure that individual logs like equipment logs, calibration logs, HPLC Column Logs, maintenance logs, cleaning, stability schedule logs, chemical usage logs, quality observation logs, training attendance logs, and other instrument logs are up to date and have been verified and reviewed on time
- Expired usage logs alert users or groups in the department.
- It enforces the steps for log recording, verifying, reviewing and approving log records as approved by SOPs and other standards.
- AmpleLogic Electronic Logbook also maintains document issuance, training attendance, SOP Issuance and Retrieval, Training log issuance register and destruction of training records,
- It maintains SOP numbering register, quality observations, SOP issuance register for uncontrolled copies, master SOP index, request issue and retrieval of bound books
- AmpleLogic Pharmaceutical Electronic Logbook Software will ensure complete visibility for the usage logs which comes with real-time validation status for equipment, instruments and manufacturing facilities
- With help of E-Log Management Software, you can upload and import logbook entries saved in one of the supported formats. We also provide a template to help organize your data in a defined template format
- This eLogs solution can integrate with machines, plc’s, historian databases, SAP and other existing applications
- AmpleLogic Logbook software allows for workflow pairing with any type of review and approval requirements with required electronic signatures as per the approved workflow procedures.
Benefits of AmpleLogic Logbook Software
- Gives ample time and concentration to business and other resources instead of data entry and error correction which the software addresses.
- This Electronic Equipment Logbook system allows for the entire process to be monitored during the course of a production.
- This eLog allows for 100% reduction of paper and manual data entry as the entire solution is automated
- There are multi-lingual capabilities
- No need for printing and binding as all the information is available in the system itself. The system provides and caters for them
- Electronic logbooks guarantee the integrity of data contained in it.
- Logbooks cannot be lost or misplaced
AmpleLogic Electronic Logbook (eLogs) is well sought after by pharmaceutical companies for recording the documentation and keeping the records in electronic form. The system is also useful for teams in Quality Control (QC).
Most of the pharmaceutical companies are accepting the Logbook Software (eLog) for recording the documentation and keeping the records in electronic form. The R&D team in Quality Control (QC) labs is opting for this system in order to maintain their GMP (Good Manufacturing Practices) logbooks
AmpleLogic eLogbook software complies with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH
If you would like to discuss how your business can benefit from AmpleLogic Electronic Logbook Management (eLogbook) Software, please contact us