Quality and compliance are the foundation of success in the life sciences industry. At Excellence Squad, we take the complexity out of quality assurance by providing tailored solutions that keep your operations compliant, efficient, and audit-ready.
From CAPA management and regulatory audits to AI-powered electronic Quality ManagementSystems (QMS), we help you streamline processes, mitigate risks, and maintain regulatory confidence.
Partner with us to transform your quality processes into a strategic advantage—ensuring compliance, improving operational performance, and safeguarding product integrity.
- Quality Management Systems (QMS)
- Corrective and Preventive Actions (CAPA) Management
- Audits (Internal and External)
- Qualified Person (QP) Services
- Risk Management
- Manufacturing Process Validation
- Computer System Validation (CSV) and Software Quality Assurance
- Post-Market Surveillance (PMS)
- Complaint Handling and Recalls
- Supplier Quality Management
- Regulatory Reporting and Documentation Control
- Change Control Management
- Training and Competency Programs
- Good Manufacturing Practice (GMP) Compliance
- Good Distribution Practice (GDP) Compliance
- Good Laboratory Practice (GLP) Compliance
- Implementation of Electronic & AI-Based Quality Management Systems (QMS)
- Cybersecurity Compliance
Quality Management Systems (QMS)
- Design, implement, and optimize Quality Management Systems (QMS) aligned with relevant global standards and regulations, including ISO 13485, ISO 9001, ISO 14971, ISO 27001, FDA QSR (21 CFR Part 820), EU MDR/IVDR, and GxP (Good Manufacturing, Laboratory, and Distribution Practices), ensuring compliance, operational efficiency, and alignment with industry best practices.
- Establish robust documentation systems, including Design History Files (DHF), Device Master Records (DMR), and Technical Documentation to meet regulatory submission requirements.
- Develop and implement Integrated Quality (Q) and Environmental Health and Safety (EHS) Management Systems that incorporate ISO 14001 (Environmental Management) and ISO 45001 (Occupational Health and Safety). This holistic approach enhances compliance, promotes sustainable operations, safeguards workforce safety, and minimizes environmental impact.
Corrective and Preventive Actions (CAPA) & Remediation Management
- Develop and implement CAPA processes to effectively address non-conformities, mitigate risks, and prevent recurrence, fostering continuous improvement.
- Provide tailored remediation plans to resolve identified gaps and ensure alignment with regulatory requirements and industry best practices.
- Support documentation, root cause analysis, and action plan development to enhance process reliability and compliance.
Audits (Internal and External)
- Conduct comprehensive audits, including internal, supplier, and regulatory audits, to identify gaps and ensure adherence to global standards. This includes:
- Pharmaceuticals & Biotech: FDA cGMP (21 CFR Parts 210 & 211), EU GMP (EudraLex Volume 4), WHO GMP, ICH Q10 (Pharmaceutical Quality System), and PIC/S GMP.
- Medical Devices: EU MDR (2017/745), IVDR (2017/746), FDA QSR (21 CFR Part 820), ISO 13485, MDSAP (Medical Device Single Audit Program).
- Clinical Research: GCP (Good Clinical Practice) compliance audits based on ICH E6 (R3) and FDA 21 CFR Part 312 for IND applications.
- Laboratories & Data Integrity: GLP (Good Laboratory Practice – 21 CFR Part 58), ALCOA+ principles, ISO 17025 for testing laboratories, and FDA 21 CFR Part 11 for electronic records and signatures.
- Supply Chain & Distribution: Good Distribution Practice (GDP – EU & WHO), Good Pharmacovigilance Practice (GVP) for drug safety reporting.
- Develop remediation strategies to address non-conformities identified during audits, including implementing corrective actions and verifying their effectiveness.
- Provide post-audit support, including detailed reports, action plans, and guidance to achieve and maintain regulatory compliance.
Qualified Person (QP) Services
- Act as an Interim Qualified Person (QP) to oversee the certification of batches for release, ensuring compliance with EU GMP requirements and product quality standards.
- Provide expert guidance on manufacturing, quality, and compliance processes to meet regulatory expectations during critical transitions or gaps.
Risk Management
- Assess and mitigate risks using tools like Failure Modes and Effects Analysis (FMEA), risk assessments, and root cause analysis to enhance operational reliability.
Manufacturing Process Validation
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate manufacturing processes and equipment, ensuring consistent performance.
Computer System Validation (CSV) and Software Quality Assurance
- Develop and execute comprehensive, risk-based CSV strategies—covering planning, IQ/OQ/PQ execution, and documentation—aligned with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. Ensure robust data integrity, secure electronic records, and consistent software lifecycle compliance. Leverage software QA best practices to maintain a validated state and support continuous improvement.
Post-Market Surveillance (PMS)
- Provide comprehensive support for post-market surveillance activities for medical devices and pharmaceuticals to monitor safety, performance, and compliance.
Complaint Handling and Recalls
- Manage customer complaints efficiently and implement structured recall procedures to safeguard product quality and maintain regulatory compliance.
Supplier Quality Management
- Ensure robust supplier qualification, periodic audits, and performance monitoring to maintain quality throughout the supply chain.
Regulatory Reporting and Documentation Control
- Maintain meticulous documentation control and ensure compliance with FDA 21 CFR Part 820 and other regulatory requirements.
Change Control Management
- Implement systematic procedures for managing design, process, and raw material changes to ensure product consistency and regulatory compliance.
Training and Competency Programs
- Provide industry-specific training on quality management, regulatory compliance, CAPA, and related standards to build organizational competence.
Good Manufacturing Practice (GMP) Compliance
- Conduct assessments and provide guidance to ensure manufacturing processes and facilities meet GMP standards for pharmaceuticals, medical devices, and biotech sectors.
Good Distribution Practice (GDP) Compliance
- Support compliance with GDP regulations for the distribution of pharmaceutical products, covering storage, handling, and transportation requirements.
Good Laboratory Practice (GLP) Compliance
- Ensure laboratory studies adhere to GLP standards, guaranteeing data reliability, consistency, and quality for preclinical research.
Implementation of Electronic & AI-Based Quality Management Systems (QMS)
- Integrate AI-powered Electronic QMS (eQMS) to enable real-time monitoring, predictive analytics, and automated compliance tracking, reducing manual effort while enhancing efficiency, accuracy, and decision-making.
- Automate key quality processes, including: CAPA investigations and deviation management to accelerate root cause analysis.
- Audit readiness and regulatory reporting to ensure seamless inspections and compliance tracking.
- Document control and change management to enhance data integrity and minimize errors.
Cybersecurity Compliance
- Provide guidance to life sciences companies on meeting data security standards, such as GDPR and other regulations. Focus on protecting sensitive patient data and intellectual property in a digitally transforming environment.
