There’s no doubt using paper for recording vital data is dangerous. In a paper-based laboratory environment, you will hear the question, “Has anyone seen my notebook?”
When you rely on paper-based systems to record data, everything you write down must be kept safe to reference notes, retrieve data, and cross-check the results. This information is fraught with risk if that paper trail is lost.
Here are eight consequential risks of running a paper-based laboratory.
1. Loss of Important Data
The most significant risk of a paper-based laboratory operation is losing the data you need to defend the laboratory’s products. Putting data on paper is dangerous because you can’t share it. You can’t easily retrieve it, and it could be a year before the data is ready to be archived electronically.
In the past, scientists would typically keep notes in a notebook for recording multiple experiments. Notebooks are notorious for getting lost or being misplaced within the laboratory itself where someone else picks it up, thinking it's their notebook.
Lost data requires scientists to repeat the experiments, even if a certificate of compliance has already been issued. You can’t stand behind a certificate of compliance without supporting data. The process of repeating experiments costs time and money, as scientists need to remember which experiments were conducted and try to duplicate it.
When the lab relies on an electronic solution like a laboratory information management system (LIMS), the LIMS automatically tells the lab if the test passed or failed. Sample notes, values, and results are easily documented in the system and backed up offsite or in the cloud.
If a stability study is commenced, the results will tell the scientist how the results have trended over time. The system can assess if the sample has passed or failed by assessing the results in context of the data from previous batches. This type of analysis is difficult to achieve with a paper-based system without going through mountains of archived data.
2. Inaccurate Reporting of Data
If data has been archived for a long period of time, it's difficult to access the historical data in a paper-based system. And if you’re looking at past data, it’s difficult to determine if the data has been compromised or if the data set is complete. It’s important your data meets the challenging regulatory environment in your industry.
Without LIMS technology, there is extensive room for human error when it comes to sampling and data collection, along with the maintenance of a chain of custody. LIMS technology provides built-in quality control and assurance measures due to automated workflows and assignments of specification tests. If any abnormalities are uncovered or if a test fails, the LIMS technology will automatically launch an investigation.
3. Risk of Fire and Flood Damage
Historically every laboratory would have an onsite fireproof safe to lock away important documents to protect them from physical damage. This worked on one condition: scientists, laboratory technicians, and managers didn’t lose their notes and remembered to put them in the safe whenever not in use.
Even when notebooks have been completed, what happens then? The data still needs to be stored, which requires an archiving process. That process could include manually scanning the data and storing it electronically—when it makes more sense to just store the data electronically in the first place.
Paper is fragile, and it has to be stored for a long time. For example, data related to pharmaceuticals for consumption need to be stored for 35 years. These paper files must be protected against water damage and fire. Something as simple as a malfunctioning ceiling sprinkler can cause permanent damage to paper files.
With LIMS, you do not have to worry about the risk of fire or water damage. Even if a fire or flood occurs in the laboratory, the data is protected and easily accessible since it is stored offsite or in the cloud. Cloud storage not only allows authorized access from any computer anywhere, but the files are encrypted, providing higher levels of security than paper-based data systems. Cloud storage systems are also backed up in separate locations to ensure a issue at one location can not lead to the loss of critical data.
4. Loss of Locally Stored Data
If one of your laboratory’s desktop computers becomes damaged, you can lose access to the electronic records that have scanned locally into the system. In-house electronic archiving is not secure unless you have made provision for storage off-site or in the cloud where data is protected. Although you can set up the infrastructure to electronically store data from a LIMS system in-house, it is far more cost-effective to use the LIMS provider’s cloud storage system for added protection.
Cloud-based LIMS technology eliminates the risk of inaccurate or corrupted data as it will log, track, record, and report on scientific data in a structured, consistent manner, ensuring a reliable chain of custody. When data is stored in the cloud, it is easy for multiple people to gain access on-demand as it preserves the integrity of the data in a safe and secure environment.
Anytime you are faced with an audit, you are able to demonstrate to auditors that the laboratory not only has control of their processes, but you can also demonstrate an accurate timeline of testing along with their results leading up to producing a certificate of compliance.
5. Illegible Notes
LIMS technology provides a level of validation paper can’t reproduce because electronic processes record everything that goes on in the background. On the other hand, paper files can be error-prone, hard to read or even completely illegible. Not all handwriting is clear to read, nor is it always easy to understand, especially if the scientist is prone to using acronyms or shorthand that may not be known to those accessing the files. Even data that is microfiche and scanned can also be hard to read, compromising data retrieval quality.
Manually maintaining a chain of custody via a paper-based system means all documentation can rapidly become cumbersome and error-prone, particularly as the number of samples being tested together grows. This automatically puts a strain on a testing environment and the accuracy of testing can be compromised.
When you take data from within the system and combine it with data from other sources, LIMS allows you to examine the impact on your product, processes, or various changes. By drilling into any changes, it takes you from an information layer to building knowledge on how to make a better product. Automation is the key to producing an accurate certificate of analysis, generating stability tables that are easy to read and building a wealth of product knowledge through data that is easily accessed, analyzed, and reliable.
6. Inaccurate Instrument Readings
Manual systems are prone to inaccurate instrument readings simply because of human error. Many laboratories insist on having a second person verify instrument readings because of the propensity to make mistakes, which can compound the error as an uncalibrated machine will produce extensive errors downstream and disqualify results that have already been generated.
LIMS quality control features include managed processes for monitoring calibrations and ensuring laboratory-wide precision. Instrument readings are automated with LIMS technology, which eliminates the risk of remembering which person performed the calibration and removing the need to have a second person verify instrument readings as they happen. This also incorporates a checkpoint where instruments cannot be used until they are calibrated in the system.
7. Human Error of Documentation
The minute you pick up pen and paper, you are prone to human error. You need to continually ask the question, “Have you written the number down accurately? It's easy to transcribe numbers back to front when writing in numbers by hand.
Paper systems are troublesome, hard to keep hold of, less safe from generating accurate results as it relies on making no human errors. It’s too easy to make assumptions with repetitive tasks, causing mistakes or switch numbers around, which throws off all data analysis compounding the error with subsequent processing. This is a major reason you want automation and bar codes for consistency in mitigating human error.
Because the samples’ processing must produce accurate results every time, any samples required to be tested need to comply with an established schedule. LIMS software ensures the required tests are carried out, correct testing procedures are performed, and testing is carried out on a consistent basis — a paper-based system can’t support this. The system has built-in checks and balances eliminating human error.
8. Failing an Audit
A common reason for failing an audit is the inability to provide the proof needed to substantiate a claim, such as in the case of sterile environments in manufacturing, where it is critical to be able to prove your facilities are sterile, which is one reason LIMS technology becomes invaluable. The system documents every single process and highlights any inconsistencies when it comes to sterilization. Any testing samples for a batch are recorded, documenting cleaning the equipment and the room to ensure there is no cross-contamination.
A LIMS brings a level of control and quality that you can’t get with paper, which eliminates multiple levels of risk. LIMS technology will log, track, record, and report on samples and scientific data in a structured, consistent manner, ensuring a reliable chain of custody in the event of an audit.
Why Do Laboratories Keep Using Paper?
The perceived costs of implementing LIMS is usually what holds laboratories from implementing LIMS technology. What paper-based laboratories don’t take into account are the hidden costs associated with misplaced notebooks, lost paper files, or the ongoing costs of archiving and storing the paper records.
The cost of not implementing LIMS technology is not zero. Consider the hours lost repeating work that has already been carried out when notes get lost, or results can’t be easily retrieved or verified. Labor costs can be horrendous if work must be repeated. Keeping a paper-based system carries additional costs of hiring a full-time specialist archivist to ensure archiving is carried out correctly. Notebooks require indexing and cross-referencing, which can be very time-consuming, as is handling individual papers and files.
In addition, to rework, laboratory managers also must consider the cost of inefficiencies and a lack of quality outcomes. This carries the risk of reputational damage along with the fallout should substandard consumer products be released.
LIMS technology helps you eliminate human error, making it a more cost-effective alternative to manual documentation than you initially thought. It ensures the safety of your records and ready access to your organization's data from any location. By conducting a cost-benefit analysis and investing in LIMS technology, you will find this strategic approach ensures that testing is consistent, compliant, and highly cost effective.