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BEPC provides consulting services for the best Life Sciences and Automotive companies around the world and Mexico. BEPC Mexico manages more than 200 Engineering projects.
BEPC offers Life Science engineering and technical consulting services that include: Process, Product, Equipment, and Software Validations for manufacturing operations. BEPC engineers are also involved in New Product Introductions as well as transferring major production lines to Mexico and to other countries. BEPC works with medical device companies in the commissioning and qualification of manufacturing clean rooms and clean room automation. Other capabilities include, Supplier Quality Auditing, Packaging Engineering, Labeling, Document Translation, Technical Writing, and Process Automation.
Corrective and Preventive Action (Capa)
documentation is created using quality management system (qms) and risk management system (rms)
corrective and preventive action are implemented
documentation is submitted for fda review
the process is investigated
Root cause analysis
fda provides verification and approval for actions taken and release
A formal notification of quality failure is opened
Manufacturing process transfers
qms and rms documentation review
validation strategy is created (vmp)
the strategies are documented in validation master plan (vmp)
Planning disconnection dates, transfer time and installation time
using qms and rms the documentation created and the updated processes are reviewed and approved
perform capability analysis
supplier qualification assurance
documentation is sent for fda review and approval
remediation projects
supplier quality assurance
remediation plan investigated
fda reviews and approves for release
field Problem or Recall
audit supplier qualification reports
perform six sigma projects using dmaic Methodology
document is generated
The process is analyzed
commissioning and qualification of clean rooms
From the urs comes the software requirement spec that serves to measure the urs
functionality for clean room protocols
vmp - validation master plan
activity and commissioning tests are documented
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sat - site acceptance test
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fat - factory acceptance test
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IQ - installation qualification
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usr - User Requirement Specs
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srs - Software Requirement Specs
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final documentation and umbrella reports are released
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oQ - operational qualification
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SOPs - standard operation procedures
finding the perfect talent
BEPC's Recruiting Team exceeds in finding the tailored experience and talent for our stakeholders' and clients' needs. Our Recruiting Center of Excellence allows our team to execute a robust recruiting process, while providing the opportunity to find the perfect opportunity for career growth in a challenging and ever changing environment. Finding the perfect talent comes from a deep understanding of requirements and skill sets. Our Recruiting Team works diligently and in compliance with these requirements.
