Data Management Practices

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In nonclinical settings, good laboratory practices (GLPs) ensure the quality of the studies conducted, including the integrity of the data collected. Features needed for compliant data management include detailed final study reports, the proper storing of all raw data, documentation, and protocols, and a responsible archivist to maintain responsibility for the stored data (1).

Development and manufacturing laboratory operations, such as quality control, have additional/different data requirements. Good lab practices rely on a study director as a single point of contact for all open-ended studies on product performance for submission to FDA for pre-market approval. As the study is being conducted, a quality assurance unit inspects each phase to oversee the integrity of the studies and compliance or non-compliance with the GLPs and records them in an index. In contrast, good manufacturing practices (GMPs) don’t require a single point of contact and depend on a quality control unit to approve and reject certain methods and procedures to determine whether products and samples meet manufacturing requirements (2).

Bio/pharma laboratories have access to a range of services and tools designed for accurate and quick sharing of data. To ensure proper data integrity procedures, the software, systems, and services should match the intended process.

LIMS and ENL

Laboratory information management systems (LIMS) are software systems intended for the management of lab samples and data to improve record keeping and reporting, and to automate and streamline workflows (3).  Because of their organized nature, LIMS are equipped for accurate and quick data sharing via data backup and mining and configuration tools.

An additional software system intended for lab data management is an electronic lab notebook (ELN). Intended for documenting research, ELNs manage and store lab research data while allowing for collaboration between members of a lab group or outside resources contributing to the lab work (4). Most platforms are also accompanied by content creation tools, workflow suitability, and integration tools for connecting to other software or online services.

The latest version of the Matrix Gemini LIMS from Autoscribe Informatics works to provide a range of labs with proper business and operational needs through configurable workflows (5). The system can mirror lab workflows and Matrix configuration tools while leaving the underlying code unchanged, making it easier for labs to upgrade product versions. It also allows users to download the specific configurations of their system and send them to the Autoscribe support team for assistance.

“LIMS investments are typically for a five to 10-year period, often longer. A truly configurable solution makes it simpler to meet changing business requirements, as well as adopt new processes, instruments, and systems as the lab evolves. This ‘future proofs’ your investment and ensures a lower cost of ownership over the lifetime of the LIMS,” said Tim Daniels, marketing manager for Autoscribe, in a press release. “A truly configurable LIMS provides every laboratory the certainty of longevity without sacrificing the flexibility to adopt the new technology and integration being driven by current Laboratory 4.0 initiatives.”

LabWare’s ELN is a paperless solution for the testing of GMP samples alongside standard operating procedures (SOPs) and standard test methods by quality control labs (6). The notebook can be incorporated into Labware’s LIMS to offer access to quality data, product specifications and control limits, training certifications, instrument calibrations, and standard or solution data.

The software also includes a compliance view that monitors the statuses of the methods as quality control analysts complete each step. Supervisors are notified when adverse events occur in the lab so problems can be corrected immediately.

NuGenesis Lab Management System from Waters Corporation uses synergistic data, workflow, and sample management capabilities to track product lifecycle from discovery to manufacturing (7). The system is equipped to link data such as sample submission and results review, stability testing, scientific search, multi-vendor software connection, laboratory inventories, data retention and legal hold, and laboratory execution methods to the businesses it is providing for. It can also adapt to different informatics environments and enable software integration and standardization without long deployment times.

Garrett Mullen, senior product marketing manager, Laboratory Management Informatics at Waters Corporation, said the NuGenesis Lab Management System is comprehensive and can readily adapt to informatics environments to easily link data from the lab to the business operations of a company so the organizations can see and know more about the lab processes (8).

Agilent’s SLIMS can manage all lab data through a web browser or cloud host so individual labs can tailor it to their own LIMS preferences. The system features sample management, an ELN, and workflow management capabilities (9).

Additionally, the system provides complete transparency for any lab sample, a workflow solution combined with protocols and external analysis platforms, an ELN module for digital note-taking and follow-up of experiments, and a sequencing tool kit.

The most recent version of the platform, SLIMS 6.4, provides an authentication module for account creation, additional analytical workflows, and instrument calibration for equipment expiration date tracking and to provide consequences for protocol steps (10).

BIOVIA’s LIMS is purpose-built to maintain the necessities of the lab management process. The system requires no custom coding and uses its own internal system administrator to organize applications, workflows, and procedures, eliminating the need for external consultants and programmers (11).

It also features automatic workflow validation that produces a complete validation document for the application, workflow, or procedure, and a fast deployment time that reduces the validation time from months to weeks.

Also from BIOVIA is the BIOVIA Inventory, a web-based platform for lab materials, equipment, supplies, and reagents mangement that can be used as a standalone or with an ELN (12).

The program works to lessen lab inventory and supply spoilage, restrict the opening and preparation of new materials when supply is already available, prevent the use of expired products, and oversee controlled and radio-labeled substances.

SampleManager LIMS software from Thermo Fisher Scientific can readily adapt to various lab methods and processes while working in conjunction with several software systems including enterprise research planning and manufacturing execution system software (13).

The system also allows for portability through a mobile app, which gives analysts the opportunity to use the system anywhere in the lab. The app uses tablet cameras and barcode scanners to scan samples and locations and lets users directly upload methods, SOPs, and results.

References

1. FDA, Code of Federal Regulations, Title 21, fda.gov, April 1, 2019.
2. Microchem Lab, “What is the Difference between GLP and GMP Laboratory Testing Regulations?,” microchemlab.com, Jan. 29, 2020.
3. Cloud LIMS, “What is a LIMS?,” cloudlims.com, Nov. 19, 2018.
4. The Gurdon Institute, “Electronic Lab Notebooks-for prospective users,” gurdon.cam.ac.uk, Dec. 3, 2019.
5. Autoscribe Informatics, “Configurable LIMS Highlighted at PITTCON,” Press Release, Jan. 1, 2020.
6. LabWare, “Pharmaceutical Manufacturing,” labware.com, Jan. 27, 2020.
7. Waters Corporation, “NuGenesis Lab Management System,” waters.com, Jan. 27, 2020.
8. Waters Corporation, “Waters’ NuGenesis Lab Management System Becomes Industry’s Most Adaptable and Comprehensive Information Management Platform,” Press Release, April 29, 2014.
9. Agilent, “SLIMS,” agilent.com, Jan. 27, 2020.
10. Agilent, “SLIMS Version 6.4 has Arrived,” agilent.com, Jan. 27, 2020.
11. BIOVIA, “BIOVIA LIMS,” 3dsbiovia.com, Jan. 30, 2020.
12. BIOVIA, “BIOVIA Inventory,” 3dsbiovia.com, Feb. 4, 2020.
13. Thermo Fisher Scientific, “SampleManager LIMS,” coreinformatics.com, Jan. 30, 2020. 

Article Details

Pharmaceutical Technology
Vol. 44, No. 2
February 2020
Pages: 46-47

Citation

When referring to this article, please cite it as L. Lavelle, “Data Management Practices,” Pharmaceutical Technology 44 (2) 2020.