Quality Engineering

Are you able to resolve the root cause?

Quality Engineering services using proven methodologies to resolve life science engineering challenges

A review of 483 / Warning Letters indicates that life science manufacturers have recurring problems with design, production and process controls, as well as CAPA, and other issues. Superficial patchwork compliance solutions are not the answer. BioTeknica’s skilled quality engineers analyze and identify the root cause, utilizing proven methodologies such as, Six Sigma, Kepner-Tregoe, and Taguchi, to effectively resolve engineering challenges. Ultimately, our root cause solutions save you time and resources.

Quality Engineering Services:

  • Process and Product Quality Issue Resolution (PPQIR)

    • Analyze quality issues
    • Identify root causes
    • Utilize statistical techniques, evaluation, and optimization
    • Develop and implement solutions

  • Implementation of DMAIC Problem Solving Methodologies

  • Validation

  • Cost Reduction Strategies

  • Business Process Re-Engineering (BPR)

At BioTeknica, we help you with:

  1. Staff Quality Engineers – quality issue analysis, solution development and implementation, production line support, CAPA process support, etc.
  2. Supplier Quality Engineers – ensuring that your suppliers meet your quality and business needs, supplier audits, supplier CAPA support, monitoring partnering with your suppliers, getting suppliers qualified, auditing, etc.
  3. Validation – validation planning, protocol development, execution, data analysis, and report writing
  4. FDA Inspection Readiness – have you done everything possible to prepare for your next inspection?