Sun Pharma is a leading pharmaceutical company based out of India. It has a portfolio of more than 2000 products with more than 50 state of the art Manufacturing sites spanning 6 continents across the world. Their manufacturing facilities are in compliance with Current Good Manufacturing Practices (cGMP) and other several regulatory agencies, including FDA, EMA, MHRA, TGA, ANVISA WHO, KFDA and PMDA etc.
Challenges and drawbacks with manual logbooks at their manufacturing facility
- Manual Log books / Log sheets, computerized spreadsheets are being issued and manually filling up the production, calibration, maintenance activity usage logs and alarm activity logs at Halol Plant facility located in Gujarat.
- Changing paper logbook templates can be an arduous and frustrating task, there are many changes to the process and this leads to adapting many different types of logbooks which need to be tailored and shared across the departments of the site.
- Manual data entry in the logbook leads to reduce productivity, irrelevant information, errors, deviation, batch running time mismatch, data integrity etc
- Binders and Logbooks are kept for major or critical analytical testing, production equipment, areas where product has been processed and to record other usage logs.
- Personnel are spending more and more time on paper log sheets that doesn’t add any value to their day-to-day operations.
- Lack of clarity, over writing, missing signatures, poor handwriting, improper filling up of daily logs on a scheduled basis and sometimes logbooks are getting misplaced.
- Audit process was delayed and quality issues were faced while trying to track the concerned logbook or entries.
- The concerned teams or department heads had to spend more time in doing repeated entries and redundant work in different logbooks
As per the regulations, logbooks must be maintained, retrieved and safely kept for reference at any time. To overcome the drawbacks, they wanted to replace paper based logbooks and implement an ‘Electronic Logbook’ System to streamline and automate the documentation of recording various log activities across the site.
And needed a system with the customizability and flexibility to meet the overall needs of the organization as well as individual user’s needs and to maintain the compliance requirements.
AmpleLogic Electronic Logbook Solution (eLogs) helped address the difficult and costly process of maintaining hundreds of logbooks and forms to comply with Good Manufacturing Practices (GMP) requirements. With secure, audit-ready, and easy to maintain electronic logs, they can now access and analyze data instantly, save time, and achieve better security.
- We Digitized all types of logbooks that are used across the facility to capture, record all log activities within the facility.
- Electronic Logbook Solution abled to create master data for equipment, instruments and functional locations.
- Entries made in the eLog are real-time and ensures review, verification, and approvals on time.
- Logbook data is stored electronically in a centralized repository and is accessible at all times for further analysis or audits.
- Easily assign logs to specific users at each facility when needed and track all actions in each logbook’s history.
- Create, analyze and share meaningful log reports that display your organization’s real-time data and use it for better decision making process.
- Keep track of all events such as production, cleaning, maintenance, breakdowns or calibration for each equipment.
- AmpleLogic Electronic Logbook Solution (eLogs) is completely compatible with Windows OS based, tablets and other devices to make their entries and review it at any time.
Our solution resulted in various benefits to the company as below:-
- Reduction in data integrity issues and increase in confidence of quality of documentation and distribution of documents
- Able to meet the compliance requirement as per 21 CFR Part 11 laid by US FDA and Annexure 11 laid by EU
- 100% reduction of paper and manual data entries, which comes with, automated system.
- User-level restrictions that do not allow anyone else to edit your log entries. Records cannot be tampered or misplaced
- Data Integrity is enhanced by using AmpleLogic eLogs as all the activities performed in the system are tracked and date and time are stamped. There is audit trail available for all transactions for a complete record
- It is very easy to track the GMP records during external audits
- Daily reports now go out each shift to stakeholders of a given area, effectively giving them the ability to review or audit from anywhere with internet access.
If you would like to discuss how you can eliminate the paper logbooks with help of AmpleLogic eLogs Solution, Contact us for a free schedule of demo