Members of the manufacturing and quality departments know that properly managing all of the documents associated with the batch record is essential. Once a facility has put in the necessary work to ensure that their batch records have been prepared according to FDA guidelines, they must make sure the review process is just as airtight.

FDA regulations state that “All drug production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.”

When it comes to the batch record the quality control unit is reviewing, this record can include data aggregated from many sources. These sources can vary as widely as the following:

• A batch report, which may incorporate context from the batch historian/MES, data from manufacturing systems such as process historians or LIMS, or alarms from the event log
• A bill of materials from an ERP
• Equipment logs from the control system
• Alarm annotation records
• PDF or CSV records from equipment skids
• Audit trail data

Gathering each of these different documents from their respective sources for several team members to review manually can be a time-intensive and inefficient task. In today’s increasingly digital world, it makes much more sense to automate the approval process and complete it electronically. With a single workflow to review everything related to batch release, conquering batch record review becomes an easily achievable goal.

There are many workflow products on the market. But just any product won’t cut it in a GMP environment. It’s essential to choose a product that is secure and GMP compliant.

Here’s how purpose-built GMP review and approval software can improve your batch release process:

No Need for Manual Attachments in Batch Record Review: Store Records in One Secure Repository

Batch record and report documents must be managed securely. Many facilities approach the review and approval process with a stapler: they manually aggregate documents as attachments. It goes without saying that printing documents and manually reviewing them by hand can be an inconsistent and, at worst, error-prone process.

With electronic review and approval software, aggregation of documents is much simpler. Upload documents from desktop or automatically upload them via an Uploader service. Storing documents together in one place as a secure package ensures that the batch record maintains data integrity. GMP review and approval software not only safeguards data but also streamlines the review process by providing a single point of access for all necessary documents.

Even if a facility is using review and approval software, if it is not built specifically for the batch record review process, it may not be as efficient as it can be. The software must allow the users to attach those documents securely for each step of review and for each specific department role.

When a facility selects purpose-designed GMP batch record review and approval software, they ensure the secure and straightforward management of their review process.

Ensure Access to the Batch Record is Secure and Role-Based

When using electronic review and approval software, only the appropriate authorized personnel have access to the records at their specific step of the process. This increases the data security of the review and approval software.

Regulatory guidelines such as the FDA’s 21 CFR Part 11 and Annex 11: Computerised Systems include specifications for electronic signatures, so it is important to choose software with compliant e-signatures. Software designed for compliance will ensure that only the appropriate roles will be able to securely sign off at the correct time.

Streamline the Review and Approval Process with E-Mail Notifications

Electronic review and approval software can make the review and approval process more efficient by letting users know when a document is ready for review automatically via email. No manual follow-ups or reminders are necessary, because the manufacturing and quality teams will know exactly when a document is ready to move on to the next stage of the process. This streamlined process immediately improves the efficiency of batch record review and approval, saving time and money.

Seamless Collaboration Between Multiple Roles and Departments

By creating one simple information hub for all different roles and departments, electronic review and approval software ensures that all departments can work together effectively. With a straightforward user interface guiding users through each step, and a traceable verification history to easily track each part of the process, all parties involved in the review and approval process know exactly what to do when, and what happened when.

You Can Throw Away Your Staplers: Batch Record Review and Approval Software Will Make Manufacturing and Quality Departments’ Lives Easier

By transitioning from a manual review and approval process to compliant electronic review and approval software, manufacturers can significantly improve their compliance documentation review and management. This important step in the digital transformation journey brings several significant benefits to the manufacturing and quality departments involved in batch review, including greater data security, compliant e-signatures, a clear workflow with notifications, and increased collaboration between departments.

Informetric Systems offers electronic review and approval software designed for compliance. AgileDoc® Workflow provides a secure, systematic solution for electronically reviewing and approving documents in regulated industries. The application organizes the collection and tracking of completed batch reports, and it automatically sends them to multiple departments for electronic review and approval. Once Workflow is complete, a digitally signed record envelope containing all digital attachments can be downloaded and stored.

Choosing AgileDoc Workflow to manage your batch review and approval process significantly simplifies and streamlines what would otherwise be a tedious and error-prone manual process. You can throw away your staplers—AgileDoc Workflow will keep your process organized.

For more information on AgileDoc Workflow, visit the product page.

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