Looking to find a more accurate and compliant alternative to paper-based record-keeping, a leading global biotechnology company wanted a digital solution to improve documentation and reduce costs. ɫ����installed its ɫ����Connect^TM for Life Sciences data intelligence platform to reduce errors, improve compliance, and give client teams greater confidence.

Challenge

Operating in 60+ countries with over $2 billion in revenue, this biotech leader develops revolutionary therapies for patients worldwide. In a highly regulated industry, the company is focused on accuracy in all aspects of its business, including cleaning services for their controlled environments.

The conventional system of manual paper logbooks to meet FDA regulatory requirements previously used was prone to errors and inaccuracies, creating time and cost inefficiencies in retrieving and storing paper documents. The client requested a better way to comply with regulations, following Good Manufacturing Practices (GMP) for pharmaceutical manufacturing.

Solution

The company partnered with ɫ����to implement ɫ����Connect for Life Sciences, a digital solution for real-time data collection and management that ensures compliance and efficiency. ɫ����Connect leverages a mobile app, QR codes, and a management dashboard for team members to digitally document work performed, rather than use paper logbooks that are error-prone and costly to store.

With ɫ����Connect for Life Sciences—designed for and with life sciences clients, they now have access to:

• Enhanced visibility and transparency. A digital record every time cleaners enter and exit a cleanroom with a digital log and electronic signatures of work completed and chemicals used.
• Data for faster more informed decisions. Real-time data collection displayed on a single dashboard gives the client and ɫ����team members immediate access to cleaning documentation.

This tech-enabled solution meets FDA requirements for electronic record keeping (CFR 21 Part 11), enhances accuracy, improves compliance, and reduces audit challenges.

"The digital audit trail for each assignment is a game-changer."

Benefits

Since August 2023, ɫ����has helped improve documentation, decreased deviations, and eliminated manual logbook errors. Teams are:

• Completing work more efficiently
• Creating digital record of dates, chemicals, and cleaning frequencies
• Validating training

ɫ����Connect for Life Sciences has helped eliminate production delays, reduce management costs, and provide consistent data and visibility versus utilizing a paper-based logbook system.

"It not only improves our documentation compliance, but it saves us money. The production, ongoing management costs, and sustainability footprint of paper logbooks is substantial, and ɫ����Connect helps eliminate all of that."
- ��������Client

ɫ����Connect for Life Sciences helps ensure compliance and reduce recordkeeping costs for a global biotechnology leader.

Find out how we can make it possible for you by calling 866.624.1520 or visiting ABM.com/lifesciences.