QA and Validation Services | GxP Compliance

Transitioning from Quality Management System (QMS) struggles to compliance with Good Clinical Practice (GCP) regulations is the way forward. ACL Digital Life Sciences' team optimizes QMS to ensure it becomes a continuous process driving ongoing improvement. We leverage proactive risk assessments, meticulous audit planning, and thorough process gap analysis to identify and address potential issues before they impact your operations. These measures will help streamline your drug development process, saving time and resources.

Our team's deep understanding of GCP regulations results in robust compliance programs for all drug development phases. We conduct GCP compliance audits across clinical sites, laboratories, data management centers, and Contract Research Organizations (CROs). This expertise extends to supporting sponsors through inspections by US and European health authorities. Also, the comprehensive mock inspection preparation services ensure your team is fully confident and prepared for regulatory scrutiny.

Clinical Quality Assurance Services

Quality Management System (QMS)

Our domain-specific experts can help companies reduce redundancy in regular activities and get it right the first time.

Gap analysis with preparing policies, standard operating procedures, guidelines, and work instructions as necessary
Quality risk management
Independent routine process/ system/ departmental audit
Mandatory study/ project audit

Managing Corrective and Preventative Actions (CAPAs)

CAPA management is the most challenging and time-consuming company quality program activity.

Training on CAPA preparation
Involved in preparing actionably CAPA
Follow-up on CAPA completion with adequate documentation
Effectiveness check to see if the CAPA is effective

External Audit Support

We have a seasoned audit team and process to support your client/sponsor audits.

End-to-end management of client/sponsor audits
From the receipt of the audit agenda to the audit preparation activities
Audit hoisting (in-person/remote)
CAPA preparation and its implementation

Inspection Preparation Support

Thorough preparation takes the stress out of inspections. Our experienced QA team is here to guide you through the process.

End-to-end management of regulatory inspection
From the receipt of inspection notification to preparation activities with the internal team, including MOCK inspection
Supporting the inspection hosting activities (in-person/remote)
CAPA preparation and its implementation