Maintain Pharmaceutical Manufacturing Compliance

Use the Shiftconnector^® Equipment Hub Digital Logbook to collect real-time data to enhance pharmaceutical manufacturingcompliance, data integrity and efficiency

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Why Is Using Digital Logbooks in Pharma Needed?

Using paper logbooks in pharma manufacturing can be challenging. They often lead to human errors, data integrity issues, and time-consuming manual entries. Plus, they're susceptible to tampering, loss, and damage. Compliance errors are another concern, and they take up a lot of storage space. When it comes to audits, finding the information you need can be a slow and cumbersome process. Our pharmaceutical manufacturing software addresses these challenges by providing secure, efficient, and easily accessible digital logbook solutions.

Benefits of Using the Equipment Hub Logbook

Shiftconnector Equipment Hub ensures that your team is compliant with standards like FDA's 21 CFR Part 11 and EU Annex 11
Minimizes risks associated with manual entries and reduces the time and costs associated with handling paper records
Provides real-time access to data, enabling better monitoring and quicker responses to issues
Ensures compliance with GxP regulations for pharmaceutical products

How Shiftconnector^® Improves Pharmaceutical Manufacturing

Shiftconnector Equipment Hub allows operators to add, edit, or archive to a digitallogbook, implement review workflows for proper signoffs, and search across multiple digitallogbooks. Equipment Hub aggregates data from BDR, LIMS, CMMS, and SCADA systems for easier event tracking, allows you to view and search detailed log history records, and easily create reports to support regulatory compliance in the pharmaceutical industry.

It ensures pharmaceutical manufacturing compliance with tailored templates, creates reports easily, facilitates multiple signoffs, and secures digital logs with multi-level password authentication.

Real-time data entry that allows for easy analysis
Easy integration with MES, ERP and more
Customization options that support GxP standards in logbooks

Logbook Overview (+Filter)

View all logbooks for your current tenant in one place. Easily search to find your specific logbook, and with a single click, access it instantly.

Logbook Details

This is the title page, showcasing all the essential details for your current logbook. It includes information on who is responsible, where it's located, and other key data. You can fully customize this page and choose different templates for various logbooks. For instance, an equipment logbook can have a unique format compared to a room logbook.

Logbook Records

Get a complete overview of all the logs within a logbook. Each entry has a unique ID that's consistent across the entire system. Plus, you can easily see any changes with the full audit trail, all visible in the list view.

Record Details with Audit Trail

Each record comes with a full audit trail. You can also restrict certain groups from updating records, ensuring everything stays secure and organized.

Quality Assurance Reviews

You can set up different review workflows for logbook entries, restricted to authorized personnel. Once a record is signed, it can be locked to prevent changes or require a full review process for any updates, ensuring no changes bypass the review. This results in a maintained GxP compliant equipment log.

Equipment Hub - All at a Glance

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Product Overview

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FAQs About Improving Pharmaceutical Manufacturing Compliance

How does Shiftconnector Equipment Hub ensure pharmaceutical manufacturing compliance?

Equipment Hub complies with regulations like FDA's 21 CFR Part 11 and EU Annex 11 by providing secure electronic records and signatures, detailed audit trails, and robust user authentication. These features help maintain data integrity and facilitate compliance with GxP requirements in the pharmaceutical industry.

What are the benefits of using digital logbooks over paper logbooks?

Digital logbooks offer enhanced data integrity, real-time data entry, automated data capture, and secure storage. They streamline compliance processes, reduce human error, save time, and provide easy access to historical data for audits and reporting.

Can Shiftconnector Equipment Hub integrate with other systems?

Yes, Equipment Hub can integrate with various systems such as ERP (Enterprise Resource Planning), LIMS (Laboratory Information Management Systems), CMMS (Computerized Maintenance Management Systems), and SCADA (Supervisory Control and Data Acquisition) systems. This integration allows for seamless data flow and comprehensive event tracking, paving the way to enhanced collaboration in the pharmaceutical industry.