A Global Pharmaceutical Leader uses SpectrumLIMS for Quality Operations Synchronization and FDA Compliance

Summary

A large Fortune 500 British multinational pharmaceutical company with operations in several countries was looking to automate its quality operations for its four plants in South Asia located in different geo-locations. The company wanted a single solution that would synchronize its manufacturing quality operations so all four of its manufacturing plants and labs would work as a single system, saving costs and achieving process uniformity, data integrity, and high product quality. After significant search efforts and multiple approvals, they decided to go with SOFCOM’s Spectrum quality management solution.

Spectrum was deployed for all four of its factories transforming its enterprise-wide operational synchronization, data integrity, FDA compliance, and achieving productivity enhancements.

Selection of Sofcom

The company needed 21 CFR part 11 compliant software to manage plant quality operations along with synchronization of its various distributed plants. The company's focus was also to find a solution that ensures labs operations uniformity and a single view for controls and visibility. SOFCOM’s SpectrumLIMS was selected for its quality operation suite after extensive research and evaluation of competitor software products. The company was especially impressed by SpectrumLIMS ease of deployment and performance in managing large operations in the industry.

Partnering with Sofcom

After the selection of Spectrum, the company decided to work with SOFCOM for solution implementation instead of any outside integrators upon SOFCOM’s assurance of full commitment to form a joint team for the work. A single team from all four company plants was assembled along with Sofcom's implementation team. The team agreed on SOFCOM’s implementation strategy and upon finishing the work received global admiration and appreciation received a certificate of appreciation and awards from the customer’s corporate office. SOFCOM team was especially recognized for its dedicated and tireless work to save enterprise-wide implementation costs.

Challenges and Implementation

The company wanted to synchronize quality operations for all its plants and Multiple labs on each plant and make them compliant with a single view of operations.
There were 3000 input materials and more than twenty thousand tests and related processes that had to be qualified and validated on the new system for compliance.
Implementation was completed in four months with complete testing and validation of all processes and tests for all four plants and labs on the selected Spectrum solution modules by the combined team of the company and Sofcom as per FDA and EU guidelines of Good Automated Manufacturing Practices (GAMP).
The implementation included all plants and all distributed labs consisting of microbiological, chemical, in-process, and other departments laboratories merging into a single pane of glass visibility for the enterprise.

Automation

All four plants' quality operations with different laboratories operations were synchronized and merged into an enterprise-wide system with a single view along with 21 CFR part 11 compliance.
Digitization of lab operations reduced compliance costs, enhanced data integrity, and a multi-lab collective approach to managing processes and resources resulted in a significant productivity increase.
Instrument calibration management ensured compliance and better instrument utilization.

Results

All four plants quality operations with different laboratories operations were synchronized and merged into an enterprise-wide system with a single view along with 21 CFR part 11 compliance
Digitization of lab operations reduced cost of compliance, enhanced data integrity, and multi-lab collective approch to manage processes and resources as a whole resulted in significant increase of productivity.
Iinstrument calibration management ensured compliance and better instruments utilization.

Conclusion

With drug quality concerns growing and strict FDA regulations enforced for people's safety, pharma manufacturers need to employ systems that help them comply with their processes and rules. Spectrum solution is an FDA-compliant laboratory data management system that ensures optimum quality control through real-time automated data processing, result extraction, and process control analytics.

Customer Endorsements

“We find Sofcom good business partners and are working closely with them to develop more innovative solutions aimed at continuous improvement in pharmaceutical manufacturing.”

– Ruby Shaikh, Head of Quality.

Partner with Sofcom

Sofcom provides enterprise-level FDA complaint multi-laboratory management solutions that Fortune 500 pharmaceutical leaders like Pfizer, GSK, and Sanofi rely on. Sofcom has been in the lab and manufacturing software business for the last 25 years and provides implementation, validation, training, maintenance, and 24x7 support for our customers worldwide.

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