Electronic Log Book in the Pharmaceutical Industry
AmpleLogic Electronic Log Book is a web-based application specifically deals with the requirements related to the Calibration, Equipment Usage, Cleaning, Stability Schedule, Standards Usage, Chemical Usage Logs, and other details log for all equipment’s. This eLog book application converts these manual paper forms into electronic versions and ensures all the entered details or logs are completed and recorded at the right time which can be verified, reviewed and approved through approval workflows.
This eLog Book/Electronic Log Book provides transparency and information sharing across all key operational departments such as quality, production, planning, and maintenance bringing visibility of production and QC lab operations to the entire organization.
AmpleLogic eLog Book solution is compliant with FDA requirements for CFR Title 21 including 21 CFR Part 11 that outlines electronic records and signatures. This Electronic Log Book Software will also comply with EU Annexure, MHRA, Good Manufacturing Practice (GMP), Standard Operating Procedures (SOP’s), ISO and other regulatory requirements
Challenges with manual paper-based log books
There are inherent challenges that pharmaceutical drug manufacturing companies face in regards to the regulatory environment. Recording the details pertaining to the calibrations, stability schedule, equipment usage, cleaning, maintenance, HPLC column logs and other log details of an equipment’s is very difficult to record and document in paper form as well as in logbooks entries. Manual data entry in the logbook reduce productivity, irrelevant information, obtain errors as well as inaccurate estimates for production quantities, etc.
This paper-based logbook created compliance issues and whereas operational process would be inefficient while capturing the details of the individual logs with user signatures, date, time, test and product details, batch numbers and lot numbers of each batch processed across multiple locations make difficult for the validation process. Logbook entries need to be reviewed periodically to ensure that data have been collected as per the approved SOP procedures. With each step of process needing a specific logbook, the number of logbooks and the time required to verify these documents will easily become overwhelming
Whenever any corrections made to a specific document or record must be signed and dated by the concern persons along with the appropriate reason for the correction to be mentioned. There will be no traceability and tracking of version documents when these are transferred from one department/facility to another. These problems require additional man-hours to work
To eliminate all the problems faced during data entries and capturing all the usage logs details across the facilities, we at AmpleLogic designed a solution i.e. Electronic Log Book specifically for FDA (GMP/cGMP) manufacturing facilities 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
- View, Print 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
- Enforce the steps for log recording, verifying, reviewing and approving logs records as per the approved SOP’s and standards.
- AmpleLogic Electronic Logbook can also maintain the document issuance, training attendance, SOP Issuance and Retrieval, Training log issuance register and destruction of training records,
- can maintain SOP numbering register, quality observations, SOP issuance register for uncontrolled copies, master SOP index and request issue and retrieval of bound books
- Ensure complete visibility for the usage logs along with real-time validation status for equipment, instruments and manufacturing facilities
- Maintain Calibration, Maintenance Service Logs, Equipment Cleaning Logs, Packing Material Logs, Out of calibration investigation logs, OOS Investigation Extension and Equipment calibration logs, etc
- User groups or departmental users will be alerted for expired usage logs
- maintain other logs details of boiler operation daily log sheet, differential pressure monitoring record, environment condition record for manufacturing rooms, etc.
- Workflow can be paired with any type of review and approval requirements with required electronic signatures as per the approved workflow procedures.
- Maintain Area and Equipment cleaning, usage logs of Standards, Columns, Chemical, Stability Schedules, ANDA and DMF Tracking Logs, etc.
Benefits of AmpleLogic eLog Book System
- Spend time and resources on adding value to your business, instead of employee hours spent in data entry and fixing errors
- The system supports a continuous monitoring process during production
- 100% reduction of paper and manual data entry
- Multi-lingual capabilities
- No need for printing and binding required as all the information is available in the system itself
- Ensures data integrity of the information contained in the electronic logbooks
- Logbooks cannot be lost or misplaced
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