Life Science and Pharmaceuticals

SoftExpert Suite is a cloud-based solution with AI designed to optimize GxP and support regulatory compliance.

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Aligned with FDA and EMA guidelines, the solution provides traceability and continuous monitoring from R&D to post-market activities. It also integrates with ERP systems to enable centralized and efficient management across operational areas.

Product Tour

Optimize your path to GxP excellence

Up to 80% reduction in the time spent on managing documents such as Quality Manual, SOPs, and Work Instructions.

Up to 50% increase in productivity by efficiently managing GxP actions, promoting user adoption and ensuring required action plans are completed by all areas.

Up to 50% reduction in time spent on inspections and audits, providing greater agility and reducing manual work.

Use cases

Learn how SoftExpert helps companies in the pharmaceutical and life sciences industries

Drive Compliance with GMP and Operational Excellence

Ensure the safety and quality of medications with a complete QMS designed for the pharmaceutical industry.

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  • Ensuring Robust document revision control with a tightly controlled and automatically linked to mandatory training requirements
  • Maintaining Integrated internal and external audits readiness within your QMS, engaging relevant teams effortlessly
  • Managing non-conformities and associated CAPAs, alongside Risk Management, utilizing intuitive automated tools for effectiveness
  • Electronic processes aligned with Good Manufacturing Practices (GMP) and FDA 21 CFR Part 11 guidelines, focusing on traceability and data integrity during audits.

 

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Regulations

Support compliance with the following standards and regulations

FDA 21 CFR Part 11FDA 21 CFR Part 820ISO 27001ISO 14001ISO 45001ISO 9001ISO/IEC 17025ISO 13485

Learn more about SoftExpert's solutions

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Quality Management
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QMS
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Business Process
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BPM
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Project and Portfolio
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PPM
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CPM
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Secure, compliant, and ready to integrate with your ecosystem

Built to connect with your existing stack while keeping governance, traceability, and control at the center.

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Glossary

Action Plan

Set of steps to solve problems or implement improvements.

ABNT (Brazilian Association of Technical Standards)

Founded in 1940, this organization is responsible for technical standardization in Brazil. Its standards aim to standardize processes, products, and services to ensure greater quality, safety, and efficiency.

5S Methodology

Workplace organization and cleanliness method.

5 Whys

A method for identifying root causes by asking 'why?' five times. Typically included in the 8D process.

Accreditation

The process by which a competent institution or body attests to the technical competence of a company to provide a service or supply a product.

Active Pharmaceutical Ingredient (API)

Substance that provides a medicine with its intended pharmaceutical effect.

Adverse Drug Reaction (ADR)

Harmful, unintended, and undesirable response to a medication.

Adverse Event

Any unfavorable medical occurrence in a patient or participant in a clinical study.

ANVISA (Brazilian Health Regulatory Agency)

The Brazilian regulatory body responsible for the regulation and oversight of medicines, vaccines, medical devices, pesticides, food, and cigarettes.

Artificial Intelligence (AI)

Technology that uses advanced algorithms and machine learning to analyze data, predict outcomes, and optimize production processes, improving efficiency, quality, and real-time decision-making.

Audit

A procedure conducted to assess the conformity of activities with standards and regulations.

Big Data

The analysis of large volumes of data to improve efficiency and quality.

Bill of Materials (BOM) Control

Management of the list detailing all components of a product.

Bioequivalence

A comparative study between generic drugs and their brand-name equivalents.

Biosimilars

Biologically similar drugs to approved reference products.

Blinding/Masking

A procedure in clinical studies where one or more parties are unaware of the treatment assignment.

Blockchain in Supply Chain

Calibration

The process of adjusting instruments to ensure accurate measurements.

CAPA (Corrective and Preventive Action)

A methodology that identifies, analyzes, and establishes corrective and/or preventive actions, allowing for the correction and prevention of problem recurrence.

Capability

The ability of a process to consistently meet product specifications and tolerances.

Case Report Form (CRF)

A document used to record all information required by a clinical study protocol.

Certificate of Analysis (COA)

Document certifying that a product complies with technical specifications.

Certification Body

Entity responsible for evaluating and certifying the compliance of products and systems with specific standards.

Certifications

Process by which a third party (certification body) assesses and verifies that a product, service, process, or system meets specific normative or regulatory requirements. Certification is carried out based on specific standards and may include audits, inspections, testing, and other evaluation methods.

Change Management

Process that assesses and mitigates risks associated with changes in processes, systems, or documentation.

Codex Alimentarius

A collection of international food standards, guidelines, and codes of practice aimed at promoting food safety, protecting consumer health, and facilitating international food trade by ensuring the harmonization of food regulations and standards worldwide.

Compliance

Adherence to legal, regulatory, customer, and internal requirements.

Computerized System Validation (CSV)

A documented process that verifies that a computerized system performs as designed for its intended use in an integral and reproducible manner.

Containment

Immediate action to control or limit an identified problem.

Contaminant

Any undesirable substance present in food as a result of environmental contamination or equipment used in food processing and/or preservation.

Contract Research Organization (CRO)

Company contracted to carry out activities related to clinical trials.

Corrective Action

A measure or intervention adopted to eliminate the causes of a nonconformity, defect, or undesirable situation, with the aim of preventing its recurrence.

Corrective Maintenance

Repairs performed after failures occur.

Cost of Poor Quality

Expenses related to errors, rework, and failures that impact quality.

Customer Complaint

Negative feedback from customers regarding provided products or services.

Decision Tree

A graphical tool used to identify critical control points (CCPs) in food safety systems.

Deviation

Failure to meet an established requirement.

Effectiveness Verification

A process to confirm that an action taken was effective.

Effluent Treatment

The process of removing or reducing pollutants in liquid waste generated by a manufacturing unit according to established standards before disposal or reuse.

Emission Standards

Set of laws regulating and controlling the amount of pollutants that can be emitted by a source, whether mobile or stationary.

Energy Efficiency

Practices to reduce energy consumption in production.

Environmental Impact Reports

Documents that assess and record the effects of an industrial activity on the environment.

Equipment Qualification

Process that certifies, through a series of evaluations, that equipment meets its intended use with integrity and reproducibility.

Ergonomics

The study of worker efficiency and comfort on the production line. It also includes actions to adapt the work environment for employee comfort and safety.

European Medicines Agency (EMA)

The European regulatory body responsible for the scientific evaluation, supervision, and safety control of medicines.

External Logistics

Management of finished product transportation to customers.

Failure Mode and Effects Analysis (FMEA)

A preventive methodology that identifies and evaluates potential failures in processes, products, or systems before they occur.

FDA (Food and Drug Administration)

The U.S. regulatory agency responsible for the safety and efficacy of drugs and food.

FDA 21 CFR Part 11

FDA regulation on electronic records and electronic signatures.

FDA 21 CFR Part 820

FDA regulation that establishes the basic requirements applicable to medical device manufacturers.

FEFO (First Expired, First Out)

'First Expired, First Out' inventory management method, where products with the nearest expiration date are used first.

FIFO (First In, First Out)

'First In, First Out' inventory management method, where the oldest products are used first.

Finished Product

Finalized item ready for customer delivery.

First-Party Audit

An internal audit conducted by the organization itself or by an entity on its behalf, aimed at evaluating the conformity of its own systems, processes, and procedures.

Flowchart

A graphical representation of process steps, used to map and analyze production processes.

Good Clinical Practices (GCP)

Coordination of all processes involved in product production and delivery.

Good Laboratory Practices (GLP)

A set of standards and procedures that ensure the quality of data generated in laboratories. GLPs cover the entire testing process, from sample preparation to the generation of final reports.

Good Manufacturing Practices (GMP)

A set of guidelines that ensure the quality and safety of pharmaceutical products during production.

(ICH) International Council for Harmonisation

Council for the harmonization of technical requirements for pharmaceuticals for human use.

Incident and Accident Analysis

Investigation of the causes of workplace failures to implement corrective and preventive measures.

Incoming Inspection

Verification of compliance for materials received from suppliers.

Industry 4.0

Integration of digital technologies in industrial production.

Information Technology (IT)

The use of information systems to support production operations.

Ingredient

Any substance used in the manufacture or preparation of food and that remains in the final product, even if modified. Includes food additives.

Internal Logistics

Management of material flow within the factory.

Internet of Things (IoT)

Connection of devices and systems to collect and share data.

Inventory

Verification of material or product stock quantities against system records.

Ishikawa Diagram (Fishbone Diagram)

A diagram used to identify potential causes of a problem.

ISO 13485

International standard for quality management systems in medical devices.

ISO 14001

International standard setting guidelines for corporate environmental management.

ISO 45001

International standard defining requirements for occupational health and safety management systems (OHSMS).

ISO 14971

Standard specifying risk management for medical devices.

ISO 9001

International standard for quality management systems.

Kaizen

Continuous improvement philosophy, part of Lean Manufacturing.

Kanban

Visual tool for controlling and managing production flow.

Key Performance Indicators (KPI)

Metrics used to evaluate success in quality and production processes.

Law

Set of legal regulations governing the production and commercialization of goods and services.

Layout

Physical arrangement of machines, equipment, and workstations on the factory floor to optimize production flow.

Lead Time

Total time required to transform an order into delivery, from start to finish.

Lean Manufacturing

Production system aimed at eliminating waste and increasing process efficiency.

Lean Production

Production system aiming for maximum efficiency with minimal waste.

Manufacturer

A company or individual responsible for producing goods or products from raw materials. The manufacturer is responsible for the entire production process, from product conception to final delivery to the customer, ensuring quality and compliance with applicable specifications and standards.

Manufacturing Execution System (MES)

Software used to monitor and control manufacturing operations.

MRP (Manufacturing Resource Planning)

System that plans the acquisition and use of materials, aligning inventories with production needs.

Non-Conformity

Failure to meet a specified requirement or standard procedure.

Occupational Safety

Employee training to prevent accidents and comply with workplace safety regulations.

Pareto Diagram

A technique that helps prioritize improvement actions based on the 80/20 principle.

PDCA (Plan-Do-Check-Act)

Continuous improvement cycle used in various processes.

Pharmacopoeias

Set of pharmaceutical codes establishing minimum quality requirements for pharmaceutical inputs, medicines, and healthcare products (e.g., European, U.S., or Brazilian pharmacopoeia).

Pharmacovigilance

Monitoring adverse effects and drug safety.

Picking

Selection of items from inventory to fulfill orders.

Pilot Batch

Batches produced to verify process and equipment suitability before large-scale production.

PPE Management

Control of the supply, use, and maintenance of Personal Protective Equipment (PPE).

PPE Record Sheet

A document recording the issuance and use of Personal Protective Equipment by employees.

Predictive Maintenance

Technique to predict equipment failures before they happen.

Process Automation

The use of technology to increase efficiency, reduce errors, and improve product quality and compliance.

Process Simulation

Use of virtual models to test and optimize production processes.

Process Validation

A set of activities proving that a process can consistently produce products of predefined quality in an integral and reproducible manner.

Product Development

The process of creating and improving new products and components.

Product Life Cycle

The stages a product goes through, from conception to market discontinuation.

Product Stability

Evaluation of product durability and safety over time.

Project Management

Planning and execution of development and production projects.

Prototypes

Initial models of a product created for testing and validation before large-scale production.

Prototyping

Creation of initial product models for testing and validation.

Quality by Design (QbD)

Systematic approach to product development, establishing comprehensive requirements throughout the entire production chain to ensure higher quality, efficacy, and safety.

Quality Complaint

Record of problems related to product or service quality.

Quality Control (QC)

Inspection of products to ensure compliance with specifications.

Quality Inspections

Procedure to examine activities and ensure compliance with quality requirements set by regulatory and standardization bodies.

Quality Management System (QMS)

A formalized system documenting processes, procedures, and responsibilities to achieve quality policies and objectives.

Quality Testing

Inspection and testing to ensure product compliance.

Raw Material

Material used as an input in product manufacturing.

Research, Development, and Innovation (RD&I)

Process aimed at creating and improving products, technologies, and processes to meet market demands or innovate.

Reverse Logistics

Process of returning products or waste for recycling, disposal, or reuse.

Risk Management

Ongoing process aimed at identifying, analyzing, evaluating, prioritizing, mitigating, and monitoring events that may affect an organization's objectives.

Robotics

Use of robots to automate production processes.

Root Cause

An analysis method to identify the primary cause of a nonconformity or food safety issue.

Root Cause Analysis (RCA)

A methodology used to identify the root cause of problems.

Safety Inspections

Regular evaluations to identify and correct workplace hazards.

Scope of Actions

The range of measures taken to correct or improve processes.

Second-Party Audit

Semi-Finished Products

Products that have undergone part of the production process but are not yet finalized.

Sensory Analysis

A scientific discipline used to evoke, measure, analyze, and interpret reactions to the characteristics of food and materials as perceived by the senses of sight, smell, taste, touch, and hearing.

Shop Floor

Production area where products are manufactured.

Six Sigma

A process improvement methodology focused on defect reduction.

Standard

Document establishing technical requirements and criteria to ensure product and service quality and safety.

Standard Operating Procedure (SOP)

Detailed instructions for performing specific tasks consistently and safely.

Statistical Process Control (SPC)

A technique that uses statistical methods to monitor and control production process quality.

Supplier Management

Coordination and evaluation of suppliers within the supply chain.

Supplier Qualification

Process of evaluating and selecting suppliers based on quality and risk criteria, also known as supplier approval.

Supply Chain Management (SCM)

Coordination of all processes involved in product production and delivery.

Sustainability

Practices aimed at minimizing the environmental impact of production.

Technology Transfer

The process of transferring knowledge and manufacturing processes from one location to another.

Temperature and Pressure Control

Monitoring and adjusting these critical parameters during industrial processes to ensure quality and efficiency.

Third-Party Audit

An independent external audit conducted by a third-party entity, such as a certification body, to verify an organization's compliance with specific standards and regulations, usually with the aim of obtaining certification.

Top Management

The group of executives responsible for the strategic and operational management of a company.

Total Productive Maintenance (TPM)

Strategy to maximize equipment efficiency.

Traceability

Ability to track the origin and history of a product and/or critical information throughout its entire lifecycle.

Value Stream Mapping (VSM)

Lean tool used to identify and eliminate waste in production processes.

Visual Inspection

Visual verification of parts or products to identify defects.

Waste Management

Planning and execution of strategies to minimize, reuse, or dispose of waste in an environmentally responsible manner.

Work Instruction (IT)

Document detailing step-by-step procedures for performing a specific task.

Workplace Safety

Practices and regulations to ensure worker safety.

Common Technical Document (CTD)

A drug registration dossier for regulatory submission.

Safety Data Sheet (SDS)

A document providing information on the hazards of chemical products and safety measures. Previously known as MSDS.

Preventive Maintenance

Regular maintenance to prevent failures.

Emission Monitoring

Measurement and control of pollutants emitted during industrial processes or transportation.

Production Planning and Control (PPC)

Management of production to meet demand.

Health Surveillance (VISA)

The agency responsible for overseeing and controlling products and services that impact public health.

Ordem de Mudança de Engenharia (ECO)

Document authorizing engineering changes.

Process Analysis

Study of a process to identify bottlenecks, redundancies, and opportunities for improvement. Central stage of the BPM lifecycle, executed after mapping the current state.

Business Rule

Statement that defines or constrains an aspect of the process, such as approval conditions or deadlines. Guides automated decisions within the execution flow.

Process Compliance

Degree to which the actual execution of a process follows the modeled flow. Measured by Process Mining tools. Indicates deviations that require correction or redesign.

Process Control

Mechanisms that ensure process execution as modeled, within expected parameters. Includes alerts, escalations, and monitoring dashboards.

ECM (Enterprise Content Management)

Strategies and technologies to capture, store, and distribute documents related to processes. Frequently integrated with BPMS solutions.

EBR (Electronic Batch Record)

A digital system used to record, track, and manage information generated during batch manufacturing, including materials, equipment, operators, process parameters, quality controls, and deviations. EBR replaces paper-based records, improving traceability, data integrity, and compliance with regulatory requirements.

Recognized Platform

An award-winning platform recognized by customers

Trusted by users and rated across leading software review platforms for value, usability, and support.

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SoftExpert's global presence, with operations on every continent, drives its growth by delivering strong, personalized service tailored to each local market.

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