Working in biotech or pharma means performing research, advancing candidates to market, and manufacturing products in compliance with regulatory guidelines, collectively known as GxP principles.
The “x” is shorthand for specific environments, including the laboratory (good laboratory practices; GLP) and manufacturing facilities (good manufacturing practices; GMP). These guidelines help ensure that data is managed correctly and that products like pharmaceuticals are manufactured with safety, efficacy, and quality in mind.
Yet, complying with these guidelines requires rigorous documentation. Adapting to GLP and GMP guidelines can be challenging for labs transitioning their operations from unregulated environments: Voluminous paper records require physical storage space, are not always immediately accessible, and require time and effort to store, secure, and manage.
These hurdles can have detrimental effects on the integrity of data (i.e., which ensures the reliability of data) collected in GxP labs or facilities. It can also negatively impact the traceability (i.e., the ability to reconstruct the development history of a product, such as a drug or medical device) and accountability (i.e., the ability to resolve who has contributed what to the development and when) of information, two key characteristics necessary if regulatory authorities need to conduct an audit.
To control these issues, web-based laboratory management software like an electronic laboratory notebook (ELN) can help manage traceability, accountability, and data integrity, three pillars of GxP compliance.
Many software options offer flexible platforms that facilitate the efficient flow and secure storage of information, keeping track of data, samples, inventory, and other critical details.
These functions are necessary for various aspects of GxP compliance and are commonly deployed to help labs and manufacturing facilities manage this process. In turn, GxP guidelines outline several requirements for those using ELNs or other software solutions.
Let’s look at GLP and GMP principles, what they are, and how ELNs can help promote regulatory compliance.
GLP guidelines are a “quality control system covering the organizational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained.”
The FDA uses GLP principles as a framework for efficacy and safety testing of pharmaceutics, veterinary drugs, cosmetic products, and other similar products.
GLP guidelines apply to personnel, facilities, protocols, standard operating procedures (SOPs), biological and chemical materials, and reporting, storage, and retention of data involved in a study.
Below, we outline three vital GLP principles that apply to ELNs and their use to manage digital data.
Raw data, including photographs, computer-readable media, observations, recorded data from automated instruments, and any other data storage medium, must be securely stored and protected from unauthorized access, changes, and loss.
Data also needs to be protected from any unauthorized modifications. Any changes must be fully auditable, with a timestamp, associated personnel, and electronic signature.
Any software or computer system that stores and retains data must be fully validated, operated, and maintained for experimental studies. GLP laboratories also need to ensure that any validated ELN software is supported through regular maintenance, technical aid, performance review, and training to ensure that ELN software is being used correctly and continues to comply with GLP principles.
Digital data should be archived so that personnel can easily access it, in a readable format, throughout a time period specified by regulatory authorities. Permission and access also must be restricted to authorized users.
GMP guidelines apply to pharmaceutical or biotech companies manufacturing products for human or veterinary use. Ultimately, these principles help to ensure the quality and safety of a product through defined requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a product.
Much like in the GLP guidelines, GMP guidance has specific regulations for electronic data management, comprehensively outlined in Title 21 CFR Part 11, the FDA regulations on Electronic Records and Electronic Signatures.
This guidance document states, “Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.”
Below are some of the essential GMP principles, as outlined in Part 11, that you’ll need to comply with when managing electronic data with an ELN.
The FDA has published a detailed software validation process that helps to ensure that any platform used is qualified for its intended purpose. Validation can be broken down into three distinct processes:
Electronic records must be fully auditable by regulatory bodies, such as the FDA. That means a historical account of all electronic records and associated activities needs to be kept and maintained.
In doing so, all records become easily traceable: If the FDA conducts an audit, they can determine what actions (creation, modification, or deletion of data) were taken, at what time, on what date, and by whom.
Therefore, all personnel must have defined user roles and appropriate permissions within a software system to ensure documentation of all activities.
An added benefit of traceability and audit trails is increased data security, a major element of Part 11 guidance. Defined user roles and permissions ensure documentation of the responsibilities and activities of all personnel involved and access only to relevant electronic information.
Password protection also improves digital security for any information stored in an ELN. Many platforms have improved security through two-step authentication, adding an extra protection layer to user accounts.
Part 11 requires that personnel ensures “…the protection of records to enable their accurate and ready retrieval throughout the records retention period.” It also requires that human-readable copies (PDF or XML) can be made from any electronic records.
Many ELNs enable comprehensive record-keeping through manual entry, equipment or software export, or linked files. Electronic signatures (so long as they are associated with an individual) can be implemented for review or approval of records, such as standard operating procedures (SOPs), and subsequently locked so that they cannot be modified or accidentally deleted. Typically, all file versions are stored and are always recoverable to make a human-readable copy. Locked digital data can be saved in a PDF format and stored in a separate electronic location as an archive.
Regardless of the regulatory environment you find yourself in, compliance is a necessary part of ensuring the safety, efficacy, and quality of experimental, non-clinical data and/or manufactured products.
eLabJournal enables users to track and manage SOPs, digital data, samples, and inventory associated with working in highly regulated markets. It is a GLP- and Part 11-compliant ELN with a robust history of success in the biotech and pharmaceutical industry.
Laboratory personnel and regulators can search eLabJournal and view the timeline for any study or record, including any change management activities. It further enables users to have a clear map of the flow of operations, whether those operations are inputting new data, archiving data, updating sample quantity, designating equipment usage, or signing off electronically on a report or experiment.
Our software includes multiple features that support GxP compliance:
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