When you are preparing your digitalization strategy, you need to list the current regulations, standards, and guidelines you adhere to and try your best to predict which ones you will need in the future.
This article will look into definitions and examples of the most common laboratory standards and regulations for laboratories. You will also learn about how regulations and standards affect digitalization and vice versa.
Standards are voluntary
Standards and guidelines as defined by International Organization for Standardization (ISO) are documents established by consensus and approved by a recognized body that provides, for repeated and common use, rules, guidelines, or characteristics on the design, use, or performance of materials, products, processes, services, systems or persons. Standards can be developed by national, regional, and international standards developing organizations and businesses or other organizations for their internal use. They can also be developed by consortia of businesses to address a specific marketplace need or by government departments to support regulations.
Standards and guidelines are not imposing a rigid and perfect set of rules on organizing activities in the laboratory but rather help laboratories find a way to get to an organized state that best fits their processes and organizations.
Example of standards applicable to life science laboratories:
- ISO 9001 (general quality management standard),
- ISO 17025 (for testing and calibration laboratories),
- ISO 15189 (for medical and diagnostic laboratories) and
- GLP (Good Laboratory Practice).
For example, a laboratory performing quantitative detection of genetically modified organisms in food can be accredited under ISO 17025 to demonstrate the quality of their services and their technical competence to the customers.
Compliance with regulations is mandatory
Regulations or codes can be described as rules of order having the force of law, prescribed by a superior or competent authority, relating to the actions of those under the authority’s control. Various government departments and agencies issue regulations to carry out the intent of legislation enacted by the legislature of the applicable jurisdiction.
An example of regulation is Title 21 CFR Part 11 (mostly known simply as 21 CFR Part 11 or even Part 11). This is a regulation put into force by the United States Food and Drug Administration (FDA). It regulates digitized processes, specifically electronic records, and electronic signatures, by defining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. As such, this regulation is law in the USA. On the other hand, the EU counterpart of the 21 CFR Part 11, the EU GMP Annex 11: Computerised Systems (frequently know simply as Annex 11), is not a legal requirement but rather a strongly recommended set of guidelines for the interpretation of the principles and guidelines of good manufacturing practice (GMP), when computerized systems are used as part of a GMP regulated activities.
How does digitalization relate to standards and guidelines
Standards and regulations affect the selection of the tools for digitalization
Before you start searching for the digital tools providers, you should list requirements for the tools that derive from a specific standard or regulation. However, if you cannot do so, include a list of names of standards and regulations that apply to your use-case. This will be harder to do for standards you did not implement yet, but it is still a useful and crucial exercise. Having a list of requirements will help you speak with vendors and ask them important questions.
Example 1
- Requirement: We need to comply with HIPPA regulations.
- Question for the vendor: Do your tool and your company supports our compliance with HIPPA regulations?
Example 2
- Requirement: We need to sign our experiments and analyses electronically. And we need an audit trail to prove the traceability of our records to auditors.
- Question for the vendor: Does your tool support that?
An important note is that the software itself usually is not “compliant”. It can support you in meeting the compliance requirements, but being compliant typically includes all actions that are taken into account within the lab and lab’s operations in general. So you should anticipate some level of adjustments to your processes when you will be digitizing or digitalizing them.
Digital tools promote good practices
Digitalization will inevitably lead to the development of internal guidelines and best practices, raising the level of quality of processes in laboratories.
For example, digital tools can bring in:
- Structure, organization, and hierarchy of data, which is sometimes enforced by digital tools; in the absence of a standardized hierarchy of data in laboratories, any agreed organizational structure is a good practice as it improves findability and goes in line with the “optimum degree of order” promoted by standards.
- Traceability of actions that users or systems perform on records, data, etc., is often a core requirement of many standards and regulations and ensures trust between the regulatory body and the laboratory, and generally reduces bad practices such as data manipulation.
- Improved control of access to information is a must in accredited laboratories, where certain actions pertain to specific roles. For example, confirmation of analyses is reserved for laboratory analysts. Or specific data (e.g., personal data or customer data) should have access limited to specific people or roles in the laboratory.
- The ability to enrich data with metadata and tags helps users group, search pieces of data, and improve findability.
- Good data management practices such as storing data in one place, data encryption, data backup strategies, and security are all aspects that are much more challenging to implement in a paper or a hybrid paper-digital system. In order to have a backup/restore or encryption in place, a certain level of IT infrastructure and expertise is needed that not every laboratory has. Therefore it is beneficial if any of these features are brought in by digital tools.
In addition to increased quality of work and outputs, digital tools also improve efficiency. Especially in cases when tools automate or replace manual or labor-intensive tasks prone to human errors. For example, if an analytical laboratory had to manually transfer the data from instruments into a LIMS system or to a spreadsheet, an additional check was performed by an independent analyst, who would verify that the data were transferred without errors. If the new tool is able to transfer the data automatically, this would make the additional quality check obsolete and make the process more efficient.
Data exchange in laboratories (data flows) is an essential and sensitive aspect and is often at the core of digitization efforts. There is an apparent lack of unified data exchange standards. However, some competing attempts look promising with a growing adoption by instrument manufacturers (e.g., AnIML, SiLA2, Allotrope). They are working to improve interoperability, which can be defined as the ability of different information systems, devices, and applications to access, exchange, integrate, and cooperatively use data in a coordinated manner. As such, interoperability strongly promotes the digitalization of laboratories not by merely making data flows seamless and improving data integrity but also by making entire processes more efficient and making the use of artificial intelligence algorithms and big data analytics one step closer.
Perhaps one of the most literal and possibly the most apparent advantages of digitalization is the reduced use of paper. In accredited laboratories, the use of paper becomes even more apparent due to retention policies for recordkeeping in regulations or standards. Laboratories are required to keep all records in a manner that ensures their legibility, storage, and retention in a way that does not compromise their retrievability. This puts a lot of pressure on laboratories to provide a suitable environment that prevents damage, deterioration, or loss of records. Although many times standards leave the retention time policy up to the laboratory, the times are commonly measured in years (e.g., 5 years is a typical retention time). In laboratories with a high throughput of sample analyses, this can become a significant and costly challenge. Some laboratories even outsource archiving of records to professional services. Although archiving and access to digital records also have their challenges, it is much more convenient and efficient than physical archiving.
Challenges related to digitalization in certified laboratories
Regulators and accreditation bodies are to various levels adapted, equipped, and familiar with digitized auditing environments. In the case of regulations that specifically cover digitized environments, such as 21 CFR part 11, regulators are much more likely to be familiar with digital systems. Especially when such regulations have been around for quite some time. For example, 21 CFR part 11 was initially published in 1997.
When it comes to standards and guidelines that cover general processes such as ISO 9001, ISO 17025, GLP, which can be perfectly well established in non-digitized and digitized environments, then regulation bodies have various levels of experience with digitized auditing environments. However, this should be less and less of a challenge as digitization expands and brings several benefits to auditors.
Sometimes the bodies that prepare and maintain standards and guidelines need some time to adapt to digital solutions, and sometimes, specific guidelines for digital environments are prepared to help auditors and consumers of the standards. One such example is the document OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring No. 17: Application of GLP Principles to Computerised Systems.
Every laboratory has good practices, possibly without even knowing. They might have been gradually introduced in time based on experience, sometimes by trial and error, and may not be written down. For example, having all protocols or standard operating procedures used in the lab by various people stored in one location; storing all raw and analyzed data on a central location on a laboratory server (and not locally on laptops).
Conclusion
Digitalization raises the level of good practices in laboratories independently of certification or accreditation. However, standards and guidelines ensure quality in laboratories by helping them organize their operations in a way that best fits their processes and organization. Therefore, standards and regulations need to be taken into account when selecting digital tools for laboratories.
Matjaž Hren, PhD is a VP of Product management at SciNote LLC
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