Are you sure you want to logout?

Confirm Cancel

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:

  1. Establish a centralized QA framework — unify disparate QA functions under standardized protocols to drive consistency.
  2. Digitize documentation and workflows — reduce manual touchpoints and increase traceability.
  3. Embed compliance into day-to-day QA operations — shift from reactive audit prep to real-time audit readiness.
  4. 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.
Let's discuss how we can help you! GET IN TOUCH

Please to View This Content.

Not a Member? Register Now

Create New Account