Analytical Problem Solving: Scientific Investigation with Purpose

In pharmaceutical environments, especially in R&D and Quality Control laboratories, technical challenges do not follow ready-made scripts.

Each analytical impasse — whether an unexpected result, an unidentified impurity, or a robustness failure — requires more than experience: it demands structured scientific investigation, technical foundation, and strategic vision.

At BizaLumière, we offer exactly that.

Beyond Diagnosis: Technical and Scientific Investigation

Our consultancy works in depth to solve specific problems through:

• Technical research in scientific and regulatory literature
  We use databases such as PubMed, USP, EMA, and ANVISA to support decisions with solid evidence.

• Scenario and analytical history analysis
  We assess previous data, trends, deviations, and critical variables to understand the real context of the problem.

• Proposing practical and applicable solutions
  We translate technical knowledge into viable actions, aligned with laboratory routines and regulatory requirements.

Examples of Problems We Investigate

• Out-of-specification results (OOS) with no evident causes

• Unknown impurities in stability or forced degradation studies

• Recovery failures in chromatographic methods

• Matrix interference in complex products

• Difficulties in validating analytical methods

• Technical impasses in photostability or compatibility studies

Problem Categorization Matrix: Technique with Clarity

To ensure assertiveness in the investigation, we use a problem categorization matrix that allows us to classify and prioritize cases based on origin, impact, and required approach:

🧪 Technical-Analytical

• Examples: OOS/OOT, low recovery, matrix interference

• Likely origin: Method, equipment, system

• Impact: High

• Expected treatment: Technical investigation, CAPA, revalidation

⚙️ Operational

• Examples: Delays, equipment failures, communication breakdowns

• Likely origin: Routine, maintenance, supplies

• Impact: Medium

• Expected treatment: Planning, preventive maintenance

📄 Documentation

• Examples: Incomplete records, GDP errors

• Likely origin: Human, system

• Impact: High

• Expected treatment: Training, document review

📋 Regulatory / Compliance

• Examples: Regulatory requirement failures, lack of approval

• Likely origin: Historical, system

• Impact: High

• Expected treatment: Process review, audit, action plan

👥 Human / Management

• Examples: Lack of training, overload, conflicts, absence of leadership

• Likely origin: Training, task redistribution

• Impact: Medium

• Expected treatment: Planning, task redistribution, mediation

💻 IT / Systems

• Examples: LIMS failures, data loss, poor integration

• Likely origin: IT, systems, infrastructure

• Impact: High

• Expected treatment: Technical support, system validation, backup

This matrix allows the investigation to be conducted with focus, agility, and depth — without losing technical rigor.

💼 Why choose BizaLumière?

Because we are a consultancy that understands the laboratory from the inside. We work with those at the bench, dealing with deadlines, pressure, and complexity. Our role is to bring technical clarity to decisions that require precision, foundation, and agility.

📬 Need technical support to solve an analytical problem?

BizaLumière is ready to help you.

We offer technical and scientific support for the investigation of analytical problems, with practical, well-founded, and customized solutions.

Get in touch and discover how to turn impasses into sustainable solutions.

📩 contato@bizalumiere.com.br
🌐 www.bizalumiere.com.br