Paper and Excel are not good for the Laboratory (and the Company’s Health)

1. Introduction

In today’s modern era of technology, many laboratories still rely on out-dated practices such as paper documentation and Excel spread sheets. These traditional methods hinder efficiency and accuracy and can also obstruct improvements in many other areas of laboratory management, some of which you may not have thought of. This article will explore the detrimental impact of paper and Excel in laboratory settings, highlighting the need for a transition to more advanced laboratory management systems. It also highlights some of the costs of getting things wrong.

Inefficiency and Error-Prone Processes

a) The use of paper and manual data entry in laboratories leads to time-consuming and error-prone processes. The risk of transcription errors, misinterpretation, and loss of data increases significantly, compromising the reliability of experimental results.
b) Excel spreadsheets, although commonly used, are not designed to handle complex laboratory data. The lack of standardised templates and limited data validation features further contribute to inaccuracies and inconsistencies. One study found that 88% of 113 spreadsheets audited had errors in their set up [1] and in a clinical setting another study found an 8.8% error rate in manual result entry [2].

2. Data Accessibility and Collaboration

a) Paper-based documentation makes it difficult to retrieve and share information efficiently. Searching through stacks of paper records can be time-consuming, leading to delays in data analysis and decision-making processes.
b) Excel spreadsheets, when used for data management, often suffer from version control issues as all data and formulae are over-written, without any audit history every time the spreadsheet is saved. In addition multiple users can make changes simultaneously resulting in data conflicts and loss of critical information.
While paper records in a notebook may seem sufficient for a small laboratory, they can quickly become overwhelming as the amount of data increases. Managing data from separate notebooks can complicate the creation of final certificates of analysis for products or samples, as well as making it difficult to retrieve data in response to a reported problem. Over time, historical data in paper records can accumulate to the point where it fills multiple filing cabinets or even entire rooms, making it extremely difficult to quickly find and compare data sets.
Laboratory managers turn to a Laboratory Information Management System (LIMS) primarily for effective and efficient data management. By having all data in a single accessible database, processes such as searching and comparing data, re-creating and reissuing certificates of analysis, producing laboratory management reports, managing instrument calibration records and staff competency, controlling inventory, and ensuring compliance with standard operating procedures become much easier. The time savings associated with using a LIMS alone often justifies the purchase of such a system.

3. Regulatory Compliance and Audit Trail

a) Laboratories are subject to stringent regulatory requirements, such as Good Laboratory Practices (GLP) and ISO standards. Paper-based systems lack the necessary controls and traceability needed to ensure compliance. Audits become more challenging, and the risk of non-compliance increases.
b) Excel spreadsheets lack the ability to provide comprehensive audit trails, making it difficult to track and verify data changes. Without an audit trail, it becomes challenging to demonstrate data integrity and the validity of experimental results.

4. Health and Safety

a) Fully integrated LIMS will include modules such as Inventory management and user competency. Inventory manager systems allow labs to closely manage the hazardous materials they may have and a competency management system can help ensure staff are correctly trained in their use and handling.
b) With a properly implemented storage management system as part of a LIMS labs can also help ensure that hazardous materials are stored only in the correct type of storage locations and that incompatible materials are kept separate.

5. Transitioning to Advanced Laboratory Management Systems

a) Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELNs) offer a comprehensive solution to the challenges posed by paper and Excel.
b) LIMS provides a centralised database for sample tracking, instrument integration, and automated data capture, ensuring data accuracy and reducing manual errors.
c) ELNs enable electronic documentation, collaboration, and data sharing, improving efficiency and facilitating compliance with regulatory requirements.
d) Implementing advanced laboratory management systems not only streamlines laboratory processes but also promotes a safer and healthier working environment.

6. Improving Data Integrity with Instrument Integration

A LIMS with an Instrument Data Acquisition System (IDAS) enables the collection of results from laboratory instrumentation, automatically extracting the required data and passing it to the LIMS. Completely eliminating human interaction eradicates typographical and calculation errors, providing repeatable quality every time and ensuring the integrity of the data recorded. In addition, IDAS speeds up the capture of results from instruments, vastly improving the efficiency of the laboratory and enabling analysts to concentrate on higher value tasks.

7. The Cost of Getting it Wrong

The cost of getting it wrong in any Industry can be catastrophic, for example in the pharmaceutical industry, where the stakes are high and the impact on human health is significant, getting things wrong can have far-reaching consequences. From product quality and safety issues to regulatory non-compliance, the cost of mistakes can be astronomical, both financially and in terms of reputation. Let’s take a closer look at some of the key areas where getting it wrong can have severe consequences.
a) Product Recalls and Liability Claims
One of the most obvious and immediate costs of getting it wrong in many industries is the need for product recalls. Whether it’s due to contamination, incorrect labelling, or other quality issues, recalls can result in massive financial losses. In addition to the direct costs of recalling and replacing products, there is also the potential for liability claims from patients or customers who may have been harmed by the faulty products. These claims can lead to expensive legal battles and damage to a company’s reputation [3].
b) Regulatory Penalties and Fines
The pharmaceutical industry, among others, is heavily regulated to ensure patient safety and maintain product quality. Failure to comply with regulations can result in significant fines and penalties. Regulatory bodies such as the Food and Drug Administration (FDA) have the authority to shut down manufacturing facilities, impose fines, and even withdraw product approvals. These penalties not only have immediate financial implications but can also have long-term effects on a company’s ability to operate and bring products to market [4].
c) Delays in Product Development and Market Entry
The process of developing a new product, especially a pharmaceutical one, is lengthy, complex, and expensive. Any missteps or errors along the way can result in significant delays in getting a product to market. These delays can be costly, as the company continues to invest in research and development without generating revenue. Furthermore, competitors may take advantage of the delay to launch similar products, resulting in lost market share and potential revenue.
d) Damage to Reputation and Customer Trust
In any industry where patient or consumer safety and trust are paramount, getting it wrong can have long-lasting effects on a company’s reputation. News of product recalls, safety issues, or regulatory non-compliance can spread quickly and erode customer trust. Once trust is lost, it can be challenging to regain, and the impact on market share and brand value can be significant.
e) Litigation and Legal Costs
When mistakes occur, especially in the pharmaceutical industry, they can lead to costly legal battles. Patients who have suffered harm or adverse effects as a result of a product’s failure may seek compensation through legal action. These lawsuits can result in substantial legal costs, settlements, or even significant damage awards, further impacting a company’s financial health [5].
f) Lost Opportunities and Competitive Disadvantage
In any industry driven by innovation and competition, getting it wrong can result in missed opportunities and a competitive disadvantage. Companies that fail to keep up with evolving regulations, technological advancements, or changing market trends may find themselves falling behind their competitors. This not only affects revenue potential but can also impact long-term growth and viability.
In summary, many industries operate in a high-stakes environment, where the cost of getting it wrong can be substantial. From product recalls and liability claims to regulatory penalties and damage to reputation, the consequences of mistakes can be far-reaching. It is, therefore, crucial for companies to prioritise quality, compliance, and customer safety to mitigate these risks and ensure long-term success.

8. Conclusion

As laboratories continue to evolve, it is crucial to acknowledge the limitations of paper and Excel-based systems. The inefficient, error-prone processes associated with these out-dated practices highlight the need for laboratories to transition to advanced laboratory management systems. In addition, these systems offer many other opportunities to improve the laboratory’s organisation. Embracing technologies such as LIMS and ELNs will not only enhance efficiency and accuracy but also contribute to a safer and healthier laboratory environment. It is time for laboratories to bid farewell to paper and Excel and embrace the future of modern laboratory management.
For more information, please email the author Dr Phil Williams at phil@lims4u.co.uk or visit ‘LIMS4U’ on LinkedIn. Phil has 38 years’ experience in Lab automation. He founded LIMS4U in 2019 and offers LIMS marketing services primarily via LinkedIn (29,000 followers).
Acknowledgements: Thanks to Autoscribe (https://www.autoscribeinformatics.com/) who supplied some of the dialogue used.

References:

1 https://www.researchgate.net/publication/8438595_Variation_in_the_transcription_of_laboratory_data_in_an_intensive_care_unit
2. https://www.researchgate.net/publication/228662532_What_We_Know_About_Spreadsheet_Errors
3. https://en.wikipedia.org/wiki/2008_Chinese_milk_scandal
4. https://www.chemistryworld.com/news/daiichi-sankyo-awarded-damages-from-former-ranbaxy-owners/1010253.article
5. https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-pay-750-million-resolve-criminal-and-civil-liability-regarding