Case Study
Health and Operational Wellness: How Grupo Farmasierra Digitized Batch Records with TrakSYS
By implementing Electronic Batch Records (EBRs) in TrakSYS, Grupo Farmasierra is on track to eliminate 100,000 sheets of paper from the shop floor every year.
TrakSYS helped Grupo Farmasierra reduce process lead times and lower changeover times across production.
Real-time data collection and analysis helped Grupo Farmasierra reduce product defects while remaining audit-ready and compliant.
With TrakSYS in place, data reliability has improved significantly. All facets of data collection, edits, and transformation are strictly controlled and recorded with electronic signatures and timestamps. The solution has been broadly adopted by the Farmasierra staff, and because of its intuitive, streamlined interfaces, staff training was straightforward and quick.
The Company
Grupo Farmasierra, a prominent life sciences manufacturing company, was founded in 1996. Located in Madrid, Spain, the company specializes in the manufacturing of pharmaceuticals, food supplements, and cosmetic products, with a product range that is continuously growing and available to healthcare professionals worldwide.
The Challenge
As its operations continued to grow, Grupo Farmasierra needed an MES software solution that could optimize today's operations while allowing for extensibility and growth in the years ahead. The company faced siloed data, disparate implementations, paper-based records, and unidentifiable causes of poor quality.
The Solution
Working with Parsec Certified Partner ASM, Grupo Farmasierra implemented TrakSYS. As a manufacturer in an industry where regulatory compliance is critical, any solution had to be designed, tested, verified, and documented per Good Manufacturing Practice (GMP) and 21 CFR Part 11 guidelines, requirements TrakSYS natively met.
ASM worked with Farmasierra to construct a TrakSYS rollout focused on truly optimizing operations, including digitalizing paper records, implementing a system of digital checks and signatures, creating electronic batch records, and enabling real-time data aggregation and analysis.
The Impact
Utilizing TrakSYS, Grupo Farmasierra reduced process lead times, reduced product defects, and lowered changeover times, all while improving production and lowering costs and remaining compliant.
The company is on track to annually eliminate 100,000 pieces of paper from the shop floor and has facilitated continuous improvement at an enterprise-wide level through real-time data.
Get the Full Grupo Farmasierra Story
See how TrakSYS helped Grupo Farmasierra digitize batch records, cut defects, and stay audit-ready under GMP and 21 CFR Part 11.
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