Auditing Services – Data Integrity

Auditing Services – Data Integrity

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.

Convinced yet? Give us a call or visit for more information.

Don’t Wait for “Them” to Find Your Weaknesses

Don’t Wait for “Them” to Find Your Weaknesses

Written by: Crystal Booth, M.M.- Regional Manager, Southeast USA at PSC Biotech

We’ve probably all heard the phrase “audit ready state”. But what does it really mean?  How do you get to and maintain an audit ready state?  An audit ready state is simply operating in a way where you are ready for an audit at any time.  This may be a client audit or a regulatory audit.   

One of the best ways to get into an audit ready state is to perform internal audits and self-audits on a frequent basis.  Have different individuals and quality assurance look over operations, processes, and physically walk-down areas e.g., Gemba Walks, etc.  Take findings seriously and implement corrective and preventative actions. During self-audits look at labeling, cleanliness, expiration dating, documentation, logbooks, equipment calibrations, reagents, blocked isles, waste bastes, incubators, etc. You want to systematically look at your area of responsibility and pretend you are a regulatory auditor.  What would the auditor see?  Your goal is to find and correct potential findings.  What you find and fix are audit observations proactively dealt with.  It is better that your internal audit systems find potential observations and implement solutions than for clients or regulators to find your weaknesses.    

Tools, such as 6S (Sort, Set In Order, Shine, Standardize, Sustain, and Safety), will help to ensure that everything is clean and in place.  Frequent self-auditing and adherence to 6S principles gives you constant feedback and allows you to adjust processes where needed to ensure you are consistently audit ready.  Remember, don’t wait for “them” to find your weaknesses.

Another tip is to be in an “audit state of mind”.  This means developing the mindset to pursue top-notch quality on a daily basis and embrace the concept of continual improvement. 

Need help getting started?  PSC Biotech™ provides custom programs to help companies get to a compliant audit ready state. Experienced consultants are available to perform audits of your facility and processes to help ensure your current processes and quality systems are compliant.   

PSC Biotech™ offers a wide variety of solutions to ensure success for any size company, including consulting, risk assessment, writing standard operating procedures, protocols, and white papers, project management or complete turnkey project services to execute projects to free up your company’s valuable resources.  Whatever your needs may be, PSC Biotech™ is here to help. Give us a call today!