Documentum or Alfresco – Quality Manufacturing – Modernizing Controlled Documentation and Batch Records

Quality Manufacturers often struggle with attempts to modernize batch records to allow for simple and accurate completion of a batch while capturing relevant quality data.  Typical start-up systems are “too small” relying on paper print-outs, handwritten values with image scanning of completed manufacturing instructions.  To capture any data for trending evaluation, all the handwritten data would have to be entered manually.  Other approaches are often “too big” with every document having to be coded into a Manufacturing Execution System (MES).  One TSG client found a way to combine the user friendly approach of robust Word documents with PDF and other manipulation controls to create a simple, modern approach for capturing data during the process without the need to code in an MES.  This post, along with a an upcoming webinar on July 31st with Alfresco will discuss the problem and solution.

UPDATE: The completed webinar has been uploaded to our Learning Zone for viewing here.

Batch Records – Too Small or Too Big Laboratory Information Systems (LIMs) and Manufacturing Execution Systems (MES) allow for automation of the batch records process through the coding of a batch record to provide for data capture with logic to complete the process accurately.  For a validated system, the requirement of updating code (or configure XML) to process a change can sometimes make the automated system difficult to adjust and almost “too big” for the typical quality manufacturer where the process can change and adjust. On the opposite side, paper based systems that rely on Word documents require intense manual effort to:

• Identify the correct documents required for a batch
• Filling in header and footer information for the batch on each of the documents
• Printing all the documents in a package
• Filling out the detail in the batch with paper and pen
• Scanning completed batches back into the system
• Hand-keying all values

Both approaches struggle on the data capture side, often times relying on database rows and tables to capture values.  With a database approach, adding new values requires not only the additional programming in the LIMS, MES or Data Capture from paper interface, but also the involvement of a DBA to add the database element, causing additional delay.

Batch Records – a document approach Struggling with the too big and too small approaches, TSG’s client decided to explore ways to leverage a document approach.  With a document approach:

• Authors can edit/change/approve manufacturing instructions in familiar Word formats consistent with document change process.
• Batch data values could be entered across and consistently within the batch
• Execution values could be captured electronically for trending evaluation

This process leverages document centric technology to flip from a ‘system’ driven approach to a ‘document’ driven approach Putting the authors in charge of their own documents gives them the agility to change their own process and documents rather than requiring a large IT project when new data needs to be collected.  For an example, let’s say the business would like to capture a temperature value for a given batch both to check that it is in a specified range but also for trending information.  For this new approach:

1. User identifies in a document where to add the temperature capture.  User adds a table element “Temperature of active ingredient at 10 minutes between 98 and 101.5” and adds a data-field “TEMP10” to the document.
2. The user would fill out a normal change request with the document to get the document approved.
3. Once approved, the next batch would include the approved document.
4. The system combines multiple documents within the batch filling substituting header information, page numbers, and other data fields in the individual documents consistently across all documents.  See a demonstration of this capability in our Learning Zone.
5. For online filling, the system looks in each document and prompts users, when processing that document, to fill out values online.  The system would recognize the additional TEMP10 field and prompt the user to complete the field.
6. The field would be rendered in the document (field substitution in Word and then rendered to PDF) for the user to verify and signoff.
7. The data for the TEMP10 would be stored and available for trending information.

Summary Implementing batch records for quality manufacturing doesn’t have to be either a too big, LIMS or MES, solution or a too small, paper and data entry.  Focusing on the document allows clients to leverage document change control to quickly change documents, automate batch record functions while still providing for capture of data. Join us for a webinar On July 31st with Alfresco: Compliant Laboratory Information Management Systems – a Modern Approach Leveraging Alfresco.

UPDATE: The completed webinar has been uploaded to our Learning Zone for viewing here.