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  • Drug Manufacturing

Why Automating Logbooks Should be the First Step to Manufacturing Automation? 

While manufacturing a batch of product, a usual Batch Manufacturing Record (BMR) varies from 200 to 400 pages. Of this, logbooks comprise about 20-40% of the volume. We can record, track, verify, and trace the activities performed during the manufacturing process using these logbooks.  

The usage of logbooks is not just limited to the production unit. They are extensively used in QA, QC, warehouse, packing, engineering, and other departments. In QA, the logbooks are used for issuance of batches, batch records, or maintenance of other essential information. QC logbooks are used to maintain details of instruments, samples, etc. Details of inventory can be stored properly using logbooks by the warehouse department. In packing, information about when the packing started and stopped, what materials were used, etc. can be recorded. The engineering department uses logbooks predominantly for schedules such as calibration schedule, preventive maintenance, and such others. The humble logbook in fact plays a significant role in maintaining the relevant data of every department of the organization.  

Complete digitalization and automation of processes is the goal to become a Tomorrow-Ready organization. The beginning, however, should happen with the basics. Logbooks, which gather data from multiple departments, can act as a strong foundation to complete manufacturing automation.  

Manual Maintenance of Logbooks 

Many production units still manually record entries in paper logbooks. They have to maintain these logbooks in storage areas for almost 5 to 6 years or until the product is in market. With manual logbook maintenance and storage, a few challenges may arise –  

  1. Logbook Issuance
    • Daily issuance and recording of logbook issuance details is an unproductive task  
    • Tracking and maintaining logbook inventory could become tedious 
    • Receiving used logbooks and archiving them in physical storage areas, sometimes even in external repositories, is painstaking as well as a costly affair 
    • Retrieval of specific logbook during audit from the storage area involves time, effort, and sometimes, transportation costs
  2. Increased Risk of Non-compliance
    • Human transcriptional errors become difficult to tackle 
    • Failure in tracking incorrect or misleading entries  
    • Potential data integrity concerns
  3. Direct & Indirect Costs
    • One-time printing costs at the beginning of the year that could be costly  
    • Design changes, misprints, and issuance errors could add up to the costs 
    • Any changes in the format or SOP could also lead to double costs 
    • Storage, risk mitigation, and retrieval costs are significant  

A simple solution to remove the concerns of a manual logbook system is to digitalize them. Logbook digitalization helps users record task details in real-time, track issuance and retrieval of logbooks, reduce transcriptional and misleading entries, and ensure data integrity. A simple step of automating logbooks can help in creating a stress-free manufacturing environment for users.  

A Cost-Effective Move 

As production has a direct impact on costs, digitalization of logbooks should be an effective move to increase profitability given that many companies end up spending a good sum annually on logbooks. It also ensures a good foundation to the current necessity of complete digitalization of the manufacturing process. Data can be retrieved easily, and it can also empower teams to attend to e-audits. Any potential changes in format, design, and issuance issues can also be tackled effectively with electronic logbooks.  

Which Logbooks can be Digitalized? 

Manufacturing companies use various logbooks to record details of the work & status at every stage of production such as 

Equipment service log  Equipment usage log 
HPLC usage logbook  Air compressor monitoring logbook 
Purified water distribution logbook  Sample registration logbook 
Sample withdrawal logbook  Sample management logbook 
Working standards logbook  Stability protocol logbook
Reference standard usage logbook  Packing material logbook 
Training material issuance logbook  Issuance and retrieval logbook 

 

The above list is only a sample of the logbooks that can be digitalized. The list of logbooks that can be digitalized is extensive and exhaustive.  

Digitalization of Logbooks with CalibereLog 

A small but mighty step towards complete automation can be made with logbooks. Digitalization of logbooks will help companies to tackle their compliance, data security, and issuance related issues.  

Choosing the right application for logbook digitalization is your next challenge. 

CalibereLog helps in complete automation of logbooks which are otherwise manually filled. By choosing CalibereLog, you can resolve many manual procedure related issues and avoid 483s. A compliant and user-friendly application, CalibereLog ensures you are audit-ready at any time. With CalibereLog, the user always feeds correct data in the logbook. The system alerts when the user makes transcriptional errors. The sections have predetermined values configured. It ensures complete data integrity as the transcriptional and other compliance related errors are at bay.  

Striding the Path to Becoming Tomorrow Ready 

As automation of production units has become an immediate necessity, Pharma companies should stride confidently to become Tomorrow-Ready by using applications like CalibereLog. Automating logbooks will help the manufacturing units transition smoothly from a manual process towards a fully secure & efficient digital process. CalibereLog will also aid the management and the users to get accustomed to the ways of production in the ‘Next Normal’. Once logbooks are automated with CalibereLog, Pharma companies can move ahead with digitalizing the complete batch manufacturing process with the right tools.  

To have a complete overview of the applications CalibereLog and CaliberBRM, sign up for a demo right now!