New guidance in 2016 under the auspices of the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) will go a long way toward ensuring data integrity throughout the processes of testing, manufacturing, packaging, distributing and monitoring medicines. Ultimately, the goal is to encourage current good manufacturing processes (CGMP) globally.
Below is a review of the seven key areas and current technologies enabling data integrity.
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- Validation documentation – In the U.S., the FDA recommends that companies implement appropriate controls to manage risks associated with each element of a system, including software, hardware, personnel and documentation. As data becomes increasingly complex, labs are finding it much easier to manage validation using integrated laboratory information management systems (LIMS) and chromatography data systems (CDS), which provide validation tool kits, control user training records and provide electronic standard operating procedure control.
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- Data transfer between systems – Data must be readable and accessible in its original form throughout the data lifecycle. A CDS offers built-in file transfer so that all relevant raw data, corresponding methods, sequence data, report formats and audit trails are included in the transfer. With an integrated LIMS and CDS, labs can create multiple lifecycles to separately manage both compliant and noncompliant processes within the same system.
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- Audit trails – New guidelines call for secure, computer-generated, time-stamped electronic records that allow for reconstruction of the “who, what, when and why.” Electronic record-keeping systems, which include audit trials, can fulfill these CGMP requirements. Chromeleon CDS tracks and automatically generates data audit trails by capturing all changes made to data objects that are done within the application, allowing users to quickly and easily compare all changes, deletions and additions.
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- Data capture/entry – A CDS will capture static data (fixed-data document/paper or electronic) and dynamic data (the record format allows interaction between the user and record content) from instruments at the source, providing bi-directional communication and from full audit trailing. Labs may elect to implement a LIMS in addition to their CDS to enable finer control over samples and capture more granular data for compliance.
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- Review of electronic data –Within a CDS, users can review any instrument’s daily audit trail, search and filter for events, and add audits to reports for review. Labs that rely on an advanced LIMS can also view any data at any time. For example, SampleManager LIMS offers built-in scientific data management system (SDMS) functionality for this very purpose, giving labs a complete overview of chromatography and mass spectrometry data, and showing when processes are drifting toward nonconformance.
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- Storage, archival and disposal of electronic data – All data generated to satisfy a CGMP requirement becomes a CGMP record and must be documented at time of performance to create a record in compliance. A modern CDS will place acquired chromatographic data immediately into a secure database which supports long-term storage, and a LIMS can automatically save records after each separate entry to meet CGMP documentation practices.
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- System security – The FDA recommends restricting the ability to alter specifications or methods to authorized individuals with access privileges for each CGMP computer system in use. Using a LIMS and CDS gives labs the ability to control what users can do and access, monitoring users’ instruments and runs through e-signatures, e-reports, auditing and versioning.
As data becomes more complex, pharmaceutical companies must constantly upgrade their systems and processes to ensure data integrity. Thermo Scientific LIMS and CDS can be a part of a company’s compliance strategy, ensuring data integrity is a built-in quality process.