Quality Management Solutions that Support Superior Life Sciences Development
The complexities of Quality Management Systems are numerous and multi-faceted. Ensuring compliance with Good Clinical Practice and handling labor-intensive CAPA management serve as prime challenges. This results in slow drug development, increased costs, and hindered the quality assurance validation process. Companies require streamlined QA and Validation services to mitigate these concerns.
In this climate, ACL Digital emerges as a viable business solution. Our tailored QA and Validation solutions address major industry pain points through intense and proactive audits, risk assessments, and compliance. Our quality assurance validation programs are a gold standard for improving operational efficiency and helping companies advance.
Seamless Quality Assurance and Audit Support Services from ACL Digital
Quality Management System (QMS)
Our expert QMS solutions encompass comprehensive gap analysis, developing critical policies, and conducting thorough audits to streamline processes and improve efficiency.
- Comprehensive gap analysis identifies improvement areas
- Tailored policies ensure compliance and efficiency
- Regular audits maintain high-quality standards
External Audit Support
State-of-the-art external audit support solutions include quality assurance verification and CAPA implementation. Our team handles all aspects of the sector, from audit agenda management to hosting remote simulations.
- Efficient audit agenda management for streamlined processes
- Remote and in-person audit simulations for preparedness
- CAPA implementation ensures corrective measures are effective
Managing Corrective and Preventative Actions (CAPAs)
Optimise your CAPA management pipeline with our expertise. We offer training, effective CAPA preparation, and rigorous follow-up to ensure the timely resolution of quality issues.
- Effective training enhances team readiness
- Timely CAPA preparation ensures swift action
- Documented follow-up verifies resolution efficacy
Inspection Preparation Support
Ease through regulatory inspections with our rigorous inspection preparation support. Our team promises end-to-end management.
- Comprehensive mock inspections simulate real scenarios
- Process validation ensures adherence to standards
- End-to-end management streamlines the inspection process
Supplier/ Vendor Selection and Qualification
Our supplier/vendor verification services streamlines your supplier selection procedure. We use benchmark metrics to provide detailed risk assessments and audits.
- Detailed risk assessments ensure informed decisions
- Rigorous audits verify supplier capabilities
- Benchmark metrics streamline selection procedures
Why Choose ACL Digital’s QA and Validation Services
Comprehensive Testing Expertise
Leverage our deep expertise in various testing methodologies, including functional, performance, security, and usability testing.
Test Automation Excellence
Benefit from our Test Automation Center of Excellence, which provides custom-built automation frameworks for efficient and effective testing.
Industry Best Practices
Our approach is aligned with industry best practices and regulatory standards, ensuring compliance and minimizing risks.
Data-Driven Insights
We provide detailed test reports and actionable insights to help you improve software quality and make informed decisions.
Continuous Improvement
We continuously evolve our testing methodologies and leverage the latest technologies to deliver the highest quality services.
Client Impact
Mitigate Audit Risk with Streamlined Vendor Management for CROs
ACL Digital Life Sciences helped a mid-sized CRO address critical vendor re-qualification delays, ensuring compliance and mitigating audit risks.
The Challenges
- Delayed vendor re-qualifications jeopardizing data integrity
- Impending sponsor audit heightened compliance concerns
- Need for a practical solution to address compliance risks
The Outcomes
- Enhanced compliance with regulatory requirements, minimizing audit risk
- Improved risk management by prioritizing critical vendor re-qualifications
- Streamlined vendor management processes for greater efficiency
- Prepared for audits with a comprehensive deviation and corrective action plan
Seamless QMS Integration for Global CRO Expansion
ACL Digital Life Sciences facilitated a smooth QMS implementation for a CRO expanding to a new location, ensuring compliance and operational efficiency.
The Challenges
- Harmonizing two distinct QA processes across locations
- Maintaining compliance with both international and local regulations
- Efficiently merging existing systems while minimizing redundancies
The Outcomes
- Developed a strategic roadmap for phased SOP updates and prioritized implementation
- Accelerated integration with on-site support from ACL Digital’s QA team
- Improved knowledge transfer through in-person training and addressed ambiguities
- Enhanced transparency with regular updates and open communication
Accelerate Clinical Trials with a HIPAA-Compliant Digital Solution
ACL Digital developed a cloud-based platform and iOS mobile app for a US healthcare startup, enabling real-time patient monitoring during clinical trials.
The Challenges
- Developing a HIPAA and FDA-compliant solution
- Reducing clinical trial timelines
- Increasing patient engagement
The Outcomes
- Accelerated solution launch by 20% exceeding expectations
- Automated data deployment for real-time patient monitoring
- Delivered a HIPAA and FDA-compliant solution mitigating regulatory risks