Pharmaceutical Quality Operations

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A top pharmaceutical global leader was looking to automate its quality operations department with FDA 21 CFR Part 11-compliant software solutions for its labs. After evaluating various software, the company selected SpectrumLIMS for its south Asia manufacturing facilities. Enterprise-wide SpectrumLIMS deployment for 2 of its factories. The Spectrum solution significantly improved productivity and compliance, more than doubling some specific tablet batches.

Company Description

One of the world’s largest pharmaceutical companies headquartered in the United States, a component of the Dow Jones Industrial Average and ranked in the Fortune 500 list.

Selection of Sofcom

The pharma company and Sofcom team implemented, integrated, and validated the Laboratory Information Management system. The company did not use third-party integrators but worked directly with Sofcom’s team due to their technical and domain expertise for the effort. As a result, the Sofcom team significantly understood the project involvement and validated all the processes on the system.

Partnering with Sofcom

The pharma company and Sofcom team implemented, integrated, and validated the Laboratory Information system. The company did not use third-party integrators but worked directly with Sofcom’s team due to their technical and domain expertise for the effort. As a result, the Sofcom team significantly understood the project involvement and validated all the processes on the system.

Challenges and Implementation

The plant’s quality operation department was using ERP LIMS, which was not FDA 21 CFR 21 compliant, and needed a validated LIMS for its factories to be FDA Current Good Manufacturing Practice (cGMP) compliant as per their corporate guidelines.
The LIMS implementation was needed to save time and resources spent on product compliance.
Monitoring and management of vendors and supplier performance for consistent product quality performance was another big challenge.

Automation

  1. Performance management of vendors, manufacturers, and suppliers.
  2. Comprehensive raw material tracking monitoring and management.
  3. In-depth control of the in-process section as per company SOPs.
  4. Automation of finished goods and packaging section as per quality operations requirements.
  5. Product stability testing and performance were also automated along with their testing schedules by monitoring product containers, their orientation, and shelf-life calculations.
  6. Spectrum LIMS, Supplier, Stability, Calibration, and Lab Inventory management modules were implemented.
  7. SOFCOM completed Spectrum LIMS implementation in 6 months with complete testing and validation of around 10K tests and raw materials.

Results

  1. Automation reduced the cost of compliance and time to market.
  2. Instrument interface and calibration management ensured data integrity and better equipment utilization.
  3. The number of batches manufactured and released increased more than twice with improved quality operations response time.
  4. Product reports, especially reporting time and effort, were automated with enormous time and cost savings. For example, annual product review preparation used to take three months to produce and was available in real-time after Spectrum implementation.

Conclusion

With growing drug quality concerns and strict FDA regulations, SpectrumLIMS with its FDA-compliant laboratory management system that ensures optimum quality through real-time automated data, processing, result extraction, and process control analytics helped to ensure that the company’s processes were compliant with the regulations.

Customer Endorsements

“Spectrum is a fully compliant solution with features like Data Integrity which is an essential aspect of regulatory compliance. Data integrity is the prerequisite for all software solutions to ensure the data generated shall always be secure with a complete audit trail and safeguarded from alteration.

The most significant advantage of Spectrum solution is the integration of all analytical instruments so that all the analytical work is connected and remains within the same close system. This unique feature provided by SOFCOM ensures the results are from calibrated instruments only.

Special feature of SOFCOM Quality Module is to Interface/Integrate with any Main Frame System.”

– Dr. I.H. Jafri, Plant Head.

Partner with Sofcom

Sofcom provides enterprise-level FDA 21CFR part 11 compliant solutions. Fortune 500 pharmaceutical leaders like Pfizer, GSK, and Sanofi rely on Sofcom, which has been in the lab and manufacturing software business for the last 25 years, providing implementation, validation, training, and maintenance. 24×7 support for our customers worldwide.

Sofcom Inc.