SQA2 Qualitics:
From Siloed to Streamlined: Elevating QA in Pharma
ISSUE:
A leading pharmaceutical company with strict compliance demands struggled with fragmented QA efforts across multiple teams. Despite a commitment to quality, inconsistencies in documentation, data handling, and audit-readiness created operational inefficiencies and elevated compliance risks.
BACKGROUND:
- The client operated in a highly regulated industry where documentation and traceability are critical.
- QA responsibilities were split across various business units with no unified process or oversight.
- Manual systems and inconsistent processes left the organization vulnerable to human error and non-compliance.
- The company’s growth amplified the complexity, exposing gaps in scalability, efficiency, and audit preparedness.
KEY SIGNALS:
- Disconnected QA functions across departments with varying standards and workflows.
- Manual review processes introduced bottlenecks and errors in documentation handling.
- Risk of compliance violations due to inconsistent tracking and lack of systemic QA oversight.
- Quality audits required excessive preparation, causing last-minute scrambles and operational strain.
STRATEGIC IMPACT:
- Increased operational risk: Gaps in documentation and process consistency threatened compliance and patient safety.
- Lost efficiency: Time and resources were drained by manual processes and redundant checks.
- Audit anxiety: Teams struggled with audit readiness, often reacting rather than preparing proactively.
- Brand vulnerability: A single compliance failure could erode trust in a highly competitive, regulated market.
RECOMMENDATIONS:
- Establish a centralized QA framework — unify disparate QA functions under standardized protocols to drive consistency.
- Digitize documentation and workflows — reduce manual touchpoints and increase traceability.
- Embed compliance into day-to-day QA operations — shift from reactive audit prep to real-time audit readiness.
- Enable cross-functional QA collaboration — break silos between business units with shared QA tools, metrics, and accountability.
EXPECTED OUTCOMES:
- Improved compliance posture through consistent, traceable QA practices.
- Reduced audit prep time and stress — shifting from reactive to ready.
- Streamlined operations with fewer bottlenecks and greater transparency.
- Increased scalability — a QA function that grows with the business.