Quality in Analytical Laboratories: Technique, Consistency, and Scientific Value

In the pharmaceutical, cosmetic, chemical, and food industries, Analytical Quality is the central axis of the reliability of results and regulatory compliance. BizaLumière offers specialized technical solutions that combine investigation, documentation, and intelligent management, with a focus on practical and sustainable results.

Our differential lies in translating complex regulatory requirements into applicable technical actions, without relying on external audits or excessive bureaucratic processes.

🏛️ Technical Support for Regulatory Requirements in the Analytical Area

Regulatory activity in the analytical area requires technical expertise, agility, and the ability to accurately interpret standards. At BizaLumière, we offer:

• Technical analysis of requirements issued by regulatory agencies, such as ANVISA, MAPA, FDA, and EMA, focusing on analytical requirements

• Preparation of technical responses to requirements in registration dossiers, post-registration, and sanitary submissions

• Critical review of analytical methods, validations, and reports, ensuring they are aligned with regulatory expectations

• Support in document organization for submissions, focusing on traceability, data integrity, and technical consistency

• Technical interface with regulatory and quality areas, facilitating communication between the laboratory and compliance

This support is ideal for companies that need to respond to requirements with speed, clarity, and technical depth — without relying on external audits or overloaded teams.

🔗 Want to better understand how BizaLumière operates in analytical regulatory support? Access our exclusive post in the Regulatory and ANVISA category, where we detail strategies, practical examples, and how to turn requirements into opportunities for technical improvement.

What Is Quality in an Analytical Laboratory?

Quality in an analytical environment means control, traceability, and data reliability. In practice, this translates to:

• Validated and robust analytical methods, with scientifically justified specifications

• Clear and updated documentation that reflects the reality of the process

• Decision-making based on statistically interpreted data

• Critical and logical investigation of deviations and atypical results (OOS/OOT)

• Technical risk management, with preventive actions and not just corrective ones

• Continuous team training, with understanding of analytical fundamentals

Quality Deviations and Technical Investigation

Analytical deviations, OOS (Out of Specification), and OOT (Out of Trend) are critical events that require a prompt and well-founded response. We operate with:

• Technical classification of deviations based on impact and recurrence

• Structured root cause investigation, focusing on evidence and analytical context

• Clear and objective documentation, with tracking of pending items and defined deadlines

CAPA Development and Quality Tools

Well-planned corrective and preventive actions (CAPA) are essential to avoid recurrence.

We use classical tools with a technical focus:

Tool / Application in the Analytical Laboratory

5W2H
Planning of corrective actions and technical improvements

Ishikawa Diagram
Root cause analysis in analytical deviations

FMEA
Risk assessment in critical methods and analytical processes

RACI Matrix
Definition of technical responsibilities in complex workflows

SPC (Statistical Process Control)
Monitoring of analytical trend and variability

All these tools are applied with technical focus and scientific rationality, without adding unnecessary layers of bureaucracy.

Review of SOPs and URS for Equipment

Document standardization is essential to ensure consistency and traceability. We offer:

• Review and preparation of SOPs (Standard Operating Procedures) with technical language and practical applicability

• Development of URS (User Requirement Specification) for acquisition and validation of analytical equipment

• Support in workflow standardization and technical training

🔐 Data Integrity and Document Management

Data reliability depends on integrity and efficient document management. We operate with:

• Application of ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Consistency, Durability, Availability)

• Version control, traceability, and secure access to technical documents

• Support in digitization and compliance with regulatory standards

⚠️ Risk Assessment in Analytical Processes

Risk management is a requirement of regulatory agencies and Good Analytical Practices. We apply:

• Mapping of critical risks in analytical methods and processes

• Tools such as FMEA and HACCP, adapted to the laboratory context

• Mitigation plans and continuous monitoring, with a focus on prevention

Laboratory Safety and PPE Management

Laboratory environments require attention to safety and ergonomics. We operate in:

• Management of Personal Protective Equipment (PPE), with definition of technical criteria, usage control, and training support

• Ergonomic assessment of workstations, in partnership with specialized companies

Change Control and Technical Change Management

Technical changes must be controlled to ensure process integrity. We offer:

• Technical support in the preparation and evaluation of Change Control

• Definition of impact, scope, validation plan, and responsibilities

• Integration with quality systems and regulatory documentation

Monitoring of KPIs and Analytical Performance

Well-defined indicators enable strategic decisions and continuous improvement. We operate with:

• Definition and monitoring of analytical KPIs, such as release time, deviation rate, CAPA effectiveness

• Customized dashboards for performance visualization

• Support in periodic review of products and processes

Ready to Strengthen the Technical Quality of Your Laboratory?

At BizaLumière, analytical quality is handled with technical depth, focus on results, and commitment to compliance. If your company needs reliable regulatory support and applicable technical solutions, contact us and discover how we can transform your processes with excellence.

Get in touch and learn how we can structure a technical quality system that works in practice — with clarity, consistency, and confidence.

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