Electronic Log Book in the Pharmaceutical Industry
AmpleLogic Electronic Log Book is a web-based software or platform that records general production requirements that are related to Calibration, Equipment Usage, Cleaning, Stability Schedule, Standards Usage, Chemical Usage Logs, and many other equipment details log. This eLog book application primarily aids the conversion of manual paper forms into electronic versions. The logbook 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 Book/Electronic Log Book ensures that information is dispersed across key operational departments in the organization. These key departments include quality, production, planning, and maintenance and helps in bringing clarity and transparency of production and QC lab operations to the entire organization.
AmpleLogic eLog Book solution has been designed with features that comply with FDA requirements for electronic records, bio data and signatures including 21 CFR Part 11. Other regulatory standards like EU Annex 11, MHRA, 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 to major regulatory bodies to serve our clients better.
Challenges with manual paper-based log books
Drug manufacturing companies encounter several incessant challenges and difficulty when they make use of manual paper-based log books. It is difficult to record the details pertaining to the equipment’s calibrations, stability schedule, equipment usage, cleaning, maintenance, HPLC column logs with 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. Validation process is also challenging because lot numbers of each batch is processed across multiple locations.
It is also important to review logbook entries repeated to ensure that these data has 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 Log Book. This is done specifically for FDA (GMP/cGMP) manufacturing facilities to overcome various challenges across the departments of an organization during log entries.
Key Features of AmpleLogic Electronic Log Book System
- 21 CFR Part 11 Compliant
- It views, Prints and Export Logs reports to different File Formats
- 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
- It enforces the steps for log recording, verifying, reviewing and approving log records as approved by SOP’s 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
- Ensures complete visibility for the usage logs which comes with real-time validation status for equipment, instruments and manufacturing facilities
- 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
- Expired usage logs alert users or groups in the department.
- AmpleLogic eLog Book allows for workflow pairing with any type of review and approval requirements with required electronic signatures as per the approved workflow procedures.
- 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.
Benefits of AmpleLogic eLog Book System
- Gives ample time and concentration to business and other resource instead of data entry and error correction which the software addresses.
- The system allows for the entire process to be monitored during the course of production.
- It 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 cater for them
- Electronic logbooks guarantees the integrity of data contained in it.
- Logbooks cannot be lost or misplaced
Electronic Log Book (eLog) 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 the Quality Control (QC).
Most of the pharmaceutical companies are accepting the Electronic Log Book (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
If you would like to discuss how your business can benefit from AmpleLogic Electronic Log Book (eLog Book) System, please contact us