Investing in Data Integrity Compliance: A holistic look at Eurofins Lancaster Laboratories investment in data management

by Travis L. Emig, Vice President, BioPharma Chemistry, Eurofins Lancaster Laboratories

Over the past several years there has been an intense regulatory push on the Pharmaceutical Industry to address potential gaps with data integrity, software validation,  system integration, and information management. Established guidance from various  agencies and sources, including FDA, MHRA, ALCOA, continues to evolve in an effort to prevent fraud and build confidence in data security, accuracy, recoverability, and overall risk management.

Eurofins places the highest value on data integrity. We recognize how critical this topic is for quality and establishing client trust. Eurofins has evaluated every legacy system we utilize  (comprising some 245 instruments and 100 different versions of application software) in an effort to enhance data integrity programs. A Failure Mode Effects Analysis (FMEA) style assessment of quality systems, technical and procedural controls of those systems was  performed based on risk. The FMEA employed all of the applicable aspects of 21CFR part 11, Annex 11 and current FDA and MHRA guidelines on data integrity. This analysis effort, and the resulting report (Gap Analysis), are used to assess each individual software/version. The results were used to create an individualized software risk mitigation strategy.

Policies and procedural controls were enhanced to remediate some individual legacy  laboratory data systems. With other systems, more time consuming, as well as costly, implementation of technological controls for remediating data integrity gaps was preferred.

Additionally, procedures for initial validation and change control were updated to ensure any new systems were assessed and remediated, prior to being allowed into production for GXP testing.

In addition to the extensive Eurofins Global IT investment in infrastructure and security, Eurofins Lancaster Laboratories (ELLI) has invested extensive capital and labor to increase technological controls, as showcased below:

• Implementation of a 3rd party enterprise software to monitor and prevent data deletion from all compatible “flat file” based systems. Monitoring over 60 stand-alone laboratory instruments currently, with unlimited capacity for future system additions.
• Establish internal reporting tools used in conjunction with the 3rd party enterprise software. These compile deletion monitoring results from all systems into a single report, assessed daily by QA.
• Software upgrades and re-validation to allow for data security, audit trail accessibility, and enhanced user access controls.
• Installation of Waters NuGenesis LMS and OpenLab as data management resources in conjunction with Waters Empower 3 Chromatography Data System and Chemstationrespectively. NuGenesis LMS allows for automated archiving of Empower 3 project data.
• Purchase, validation and implementation of 3rd party, fully electronic, validation lifecycle documentation and tracking software.
• Windows operating system upgrades allowing data systems to remain current with updated vendor software assuring overall system security
• Upgrading stand-alone software technology to enterprise level systems that inherently utilize database technologies restricting unwarranted data deletion, increasing remote data review ability, without inhibiting ongoing data acquisition and sample data throughput.
• Upgrades to existing, stand alone, analytical instrumentation software allowing for use of unique log-ins for secondary quality review of audit trails, data and metadata without inhibiting ongoing data acquisition.
• Electronic Notebook integration with instruments for direct data capture.

Subsequent to upgrades and enhancements, the requirements of data review staff have changed dramatically. Migrating to electronic record review processes has required purchasing of licenses for user accounts, administration of specific system data review training, and regulatory education on audit trail review and orphan data assessment. This equates to a significant increase in labor needed to perform the data review. Eurofins strives to find efficiencies in any system, be it software, LIMS, Electronic Notebook, etc., however efficiency gains made do not offset the increased labor needed to now perform data review in a fully electronic world.

Bullet points are provided to demonstrate the key objectives in our quality review program.

Legacy Eurofins Practices (High Quality baseline)

• Laboratory Ethics and Data Integrity Policy/Training
• Full utilization of electronic notebooks for documentation and data capture
• Zero tolerance position for illegal, unethical, or improper practices affecting the testing and reporting process
• Review of audit trails at the time of release for high volume/high risk systems.
• Periodic traceability audits by QA

What Eurofins has implemented

• Review of audit trails at the time of release for additional systems
• Periodic audit trail review of systems
• Robust backup/restore process + periodic QA check
• Balance/ ELN integration
• Conservative process on evaluating invalid and system suitability failure runs
• Conservative view of evaluating changes to raw data
• Improved Cyber security

What Eurofins is planning

• Integration of other instruments with ELN
• Enhancing disaster recovery procedures
• Implementation of additional , efficient, electronic notebook recipes and templates
• Implementation of digital signatures

Estimations on the investment levels are provided for reference. This was necessary for ELLI to achieve an industry leader position in the area of data integrity and management.

Capital expenditures: $1.5M USD

Direct Labor Headcount (Quality Engineering, Quality Assurance, Electronic Notebook, Systems Administration Specialists): 12 additional Staff

Indirect labor headcount (Data review, Validation Specialist): 25% increase over 2 years.

Throughout these efforts in addressing the current expectations for data and software management, ELLI has kept focus on achieving efficiency with tools and processes to control the overall cost to our business. However the costs simply exceed what can be gained through efficiency. ELLI pricing has reflected this added operation cost. However, customers can be confident that Eurofins is exceeding expectations in data integrity compliance.