Data integrity has become crucial to compliance for regulated life science companies.   Data Integrity assures the completeness, consistency, accuracy, authenticity, timeliness, and reliability of your data.

Whether your company is a biotechnology startup, pharmaceutical company, blood bank, gene therapy research institute, medical diagnostics facility, food and beverage corporation, you rely on digital data. Data Integrity shortcomings can lead to increased compliance costs to remediate the FDA citations, Warning Letters, and even delay your product approvals.

  1. Experts recommend that your data integrity program follow the ALCOA+ principles to achieve and maintain data integrity.
  • Attributable to the person, system, or data generating the data: What is the source of the data? Who did the data collection and performed the analyses?
  • Legible, traceable, and permanent: Is the data readable and understandable? Is it stored in a durable medium?
  • Contemporaneous: Where and when was the data created? Was it recorded as it was generated or observed?
  • Original: Is it an electronic record or metadata? Have the original records been preserved? Are they easily retrievable?
  • Accurate: Is the data error-free? Has it been maintained, updated and modified well?
  • Complete: Is all data available? Has anything been deleted?
  • Consistent: Has the data been chronologically arranged? Are there date and time stamps on the records?
  • Enduring: Will the data last even after 20 years? Will it lose readability after a long period of time?
  • Available: Can the data be accessed throughout its lifetime?
  1. Assess your systems for situations that might lead to data security breaches or compliance issues. Implement proper controls.
  2. Identify your products and processes with electronic data capture, such as automated HPLC systems, etc., high rates of Out Of Specifications (OOSs), and restrictive stability specifications. Implement appropriate controls for your high risk systems.
  3. Document results, observations, and discrepancies carefully. Pay special attention to orphan data or excluded data.
  4. Develop and implement corrective and preventive action (CAPA) plans to eliminate undesirable situations and non-conformities, and to improve data integrity.

Our team at PSC Biotech™ understands the data integrity responsibilities and provides audit and remediation services for data integrity.

Our insightful audit reports promote effective data integrity and record management strategies, and encourage data protection and privacy. We ensure our clients meet the standards set by the U.S. Food and Drug Administration (FDA), the European Commission (EC), an regulatory Agencies throughout the world. Whether you do research and development, clinical trials, quality control, manufacturing, data management or inspection, PSC Biotech™ can help you establish, evaluate, and improve your data integrity.

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