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Quality System
Our system for ensuring quality is a thorough framework that aims to maintain the integrity, reliability, and compliance of clinical research activities.
Our quality system encompasses various processes, procedures, and controls that govern the conduct of all our study activities.
- Standardized operating procedures
- Training and qualification programs
- Document management systems
- Risk management practices
- Monitoring and auditing mechanism
- Regulatory compliance measures
The quality system aims to maintain the highest standards of participant safety, data accuracy, and ethical conduct throughout the research process, while adhering to applicable regulations and guidelines.
Standard Operating Procedures (SOP)
SOPs are the backbone of our Quality System
We have SOPs available for all activities, classified by category. These categories include study conduction, general SOPs, and quality systems SOPs.
- The study conduction category includes SOPs for protocol preparation, subject recruitment, IMP process, dosing, sample processing and storage, method validation, subject analysis and acceptance, repeat analysis, ISR, statistical analysis, report writing, and archival.
- The general SOPs category includes SOPs for training, qualification, calibration, operation of instruments, change control, deviations, investigation, data integrity, computer software validation, and data backup.
- Finally, the quality systems SOPs category includes SOPs for system and process audits, document control, vendor audits, management review, and handling audits.
At Accutest, we strive for uniformity throughout the organization by harmonizing our SOPs across all centers. These SOPs are regularly reviewed to ensure they align with current regulatory requirements. As a result, we maintain a consistent and up-to-date approach towards our operations.
Training and qualification programs
- In order to maintain high-quality standards, training is a vital component of our system.
- It guarantees that all individuals participating in research and testing procedures possess the necessary skills and expertise.
- Our comprehensive training programs encompass a range of topics, including Good Laboratory Practices (GLP), safety protocols, and industry-specific procedures relevant to CRO.
Document Management System
Our DMS system is designed to empower teams to create and securely share content from anywhere and any device. It's customized efficiently and intuitively to ensure data integrity, accurate and complete documentation, and adherence to ethical standards.
- Our organization's document management system provides a safe and reliable platform for managing emails and documents throughout the entire company.
- To ensure a document can't be changed, it must be in a secure format before it's distributed. In a regulated setting, it's important to have traceability and versioning guarantees when sharing electronic copies.
- Managing the storage of documents involves various tasks such as determining their storage location, duration of storage, transferring them between storage media, and eventually disposing of them.
- In order for us to allow for the reconstruction of our document's history within the system, it is essential that we maintain a clear and accurate audit trail. This will enable us to easily track who made changes to the document throughout its lifespan.
Milind Nemane
QA Head (Mumbai)
"Quality is not an ACT it is a HABIT, our team of qualified, experienced and trained auditors ensure Quality at every step of the process for the satisfaction of our customers."
Mrunalini Dave
QA Head (Ahmedabad & Vadodara)
"Our quality system serves as a compass guiding us towards credibility, trust, commitment to subject/volunteer safety and ethical conduct of study..."