Laboratory Document Control: A Simple (But Complete) Guide

An efficient laboratory document control system is essential for the lab manager to keep records of all processes in place and documents always up-to-date.

Medical laboratories and testing companies must have complete control over their documents and protocols to ensure the quality standard of the organization. Laboratory document control is a critical process to adhere to regulatory requirements, such as GLP compliance, ISO 15189:2012, and 21 CFR Part 11.

Leading medical companies are already using software to automate their workflows, increasing the quality management, reproducibility, and repeatability of the processes at hand.

It is time for all companies to start using these systems in their routines.

In this article, we will learn more about the definition of laboratory document control, its importance in daily activities, the types and regulatory requirements for each document and record, best practices, and what to look for when implementing a digital system.

Note: If you need to streamline your document control workflow, it is smart to invest in efficient quality management software. With SimplerQMS, you have an all-in-one QMS software with robust document control capabilities – book a demo to see it in action.

We will cover the following topics:

• What is Laboratory Document Control?
• The Importance of Laboratory Document Control
• Types of Laboratory Documents and Records
• General Document Control Requirements
• Laboratory Document Control Best Practices
• Implementing a Laboratory Document Control Software

What is Laboratory Document Control?

Laboratory document control is a multi-step process for preparing, revising, approving, distributing, and maintaining necessary laboratory documentation.

But what are these essential documents?

Inside a medical laboratory and testing company, these are any written materials used to get the work done. They can be quality manuals, user guides, equipment calibration reports, Standard operating procedures (SOPs), test tracking systems, personnel files, and so on. More on this later.

To this day, some companies still manage documents and records using a traditional paper-based or hybrid system. However, this can cause some challenges, such as:

• Needing physical storage space. Keeping a massive amount of paper is a challenging task. It requires physical space in the company and a lot of organization from the employees to put everything in the right place. Moreover, in the worst-case scenario, you could lose years of documentation if a disaster such as a fire, occurs.
• Finding documents during an audit. It is necessary to present all the requested documents to the auditor, and picking up different binders in different locations is laborious and time-consuming. Having all documents at your disposal electronically certainly facilitates the audit process.
• Keeping documents free of error: Medical laboratories and testing companies need their documents to be accurate and correctly filled out to ensure their results and compliance with legislation. Documents filled out on paper can easily be done wrong due to spelling errors or mismatched information, affecting the entire workflow.

On the other hand, an electronic document control system provides a solution to help companies automate and standardize activities to improve the organization’s quality management.

Let’s think about a common situation for better understanding.

You must operate specific equipment following an SOP during your daily laboratory activities. Let’s say there is a revised version of this SOP made recently. You could access the latest version on the spot if it was created using a controlled document.

Document control software by SimplerQMS allows for robust controls of all documents that help you comply with applicable legislation. You can use the familiar Microsoft Office application to create, edit documents, and digitally sign off the documents.

The Importance of Laboratory Document Control

Commitment to quality is the basis of any life sciences organization. Since medical decisions are made based on laboratory results, it is necessary to be able to trust your procedures and documents.

Let’s see four benefits that highlight the importance of document control.

1. Increased Process Efficiency

Having effective document control allows the company to know where all its information is.

It can be laboratory results, adverse events in clinical trials, medical device complaints, or any other detail related to the product.

Imagine a company implementing a new laboratory assay and developing a new SOP. The lab manager will know this SOP’s progress by checking the employees’ updates and signatures.

2. Improved Regulatory Compliance

Companies must comply with national and sometimes international regulations, following guidelines and standards.

Having control of your documents avoids problems such as lost documents, misplaced information, and unfilled forms.

For example, employees can easily find and present any requested documents during an audit.

3. Enhanced Security

Documents in life science companies contain private information that everyone cannot access. Knowing which documents are restricted, where they are, and setting access levels is critical to ensure that there is no unauthorized use of sensitive information.

Ultimately, the best way to ensure your documents’ integrity is to control how they are produced, where they are stored, and who has access to them.

4. Streamlined Quality Management System

Laboratory document control and Laboratory Quality Management System (QMS) help clinical and medical laboratories ensure the highest quality standards of each result and document produced.

Suppose a laboratory using paper-based document control switches patient blood results, leading to wrong diagnoses and treatment. This kind of error would hardly occur using software for document control processes.

As we can see, manual or hybrid laboratory document management processes are prone to errors. The high volume of paper can lead to files being switched, lost, overdue, and filled in incorrectly.

A digital document control solution eliminates these problems by automating and streamlining document control workflows and allowing the laboratory staff to focus on more critical tasks.

Types of Laboratory Documents and Records

A laboratory can produce several different kinds of written materials. The purpose of documents and records is always to keep track of information and be able to find it when needed.

Good materials are written to be user-friendly, clear, accurate, and concise to ensure understanding for all staff.

Laboratory documents and records share the same goal but have slight differences.

Let’s understand this better.

Difference Between Documents and Records

Laboratory documents communicate updated knowledge with all laboratory staff, setting standard templates for reporting information.

These materials must be reviewed periodically when policies, processes, and procedures change.

It is also essential to know how these documents relate to each other:

• Policies are the general direction to follow regarding the quality system. Think about it as the “what to do” in every situation.
• Processes are events made over time to carry out a policy. They are the “how it happens” mainly represented in flowcharts.
• Procedures are step-by-step instructions for every activity performed in the laboratory. They are the “how to do it” in detail.

Some examples of the documents are:

• Quality manual
• Standard operating procedures
• Personnel files
• Etc.

Laboratory records collect data produced during laboratory tests. This information is permanent, does not require updating, and needs to be easily accessed.

Some examples of the records are:

• Equipment cleaning records
• Calibration checks
• Sample logs
• Patient records
• Etc.

Types of Documents

Training staff in clinical and medical laboratories is essential, and writing all the information is best to avoid being misunderstood or forgotten.

There are different types of laboratory documents. So, let’s have a look at some of them.

Standard Operating Procedures (SOPs)

Standard operating procedures (SOP) is one of the most known documents, it supplies the user with step-by-step instructions to perform any activity inside a laboratory. It ensures procedures are consistently done regarding the person performing them.

For example, collecting a blood sample following an SOP in a clinical laboratory helps guarantee that the staff had the right patient, filled out the proper form, and correctly identified the tube test.

Quality Manual

The quality manual provides guidelines for implementing the quality system and can be used internally and externally in audits.

It was first required by ISO 9001 for all quality management systems.

Quality Control (QC)

Quality control (QC) document reports the processes used to ensure the quality of products or systems. Laboratories must run quality control assays periodically and document all results, problems, and corrective actions using graphs to visually evaluate findings over time.

Typically, a test is performed with a known material to measure the accuracy of the test system.

Imagine a glucose quality control assay. To assure the equipment’s accuracy, you need to run a control reagent that produces results on an average of 100 mg/dL. After testing it ten times, the results range from 96 to 102 mg/dL, indicating that the equipment is accurate. It is necessary to document this data for future audits.

Quality Assessment (QA)

Quality Assessment (QA) document reports the quality and performance of all laboratory-related activities. Data collection and analysis are used to evaluate how effective are the current policies and procedures.

Furthermore, quality checks must be planned and conducted regularly on all processes.

For instance, your laboratory collects human urine samples and identifies each patient using a QR code. Periodically reviewing the related SOP regarding the QR code labeling can reduce the number of mismatched identifications.

Personnel Files

Clinical and medical laboratories must have documents about the employees, including, but not limited to:

• Annual safety training
• Continuing education
• Diplomas
• Records of any exposure incidents
• Vaccination status
• Etc.

Instrument Files

Each instrument used in the laboratory needs to have a document that reports its:

• Name
• Model
• Serial number
• Warranty information
• Supplier contact
• User guides
• And any other information related to its traceability

Equipment Maintenance

Equipment maintenance documents report the actions to ensure optimal instrument performance.

Usually, in the form of a log, it includes:

• How to perform proper maintenance
• Preventive maintenance
• Frequency
• Dates
• Responsible staff

Temperature and Humidity Logs

It is essential to maintain an appropriate environmental temperature and humidity to test accuracy and reproducibility. These parameters must be monitored and recorded daily.

If out of range, corrective actions must be taken and recorded in the log.

Proficiency Testing

Documents related to proficiency testing are part of a quality system for interlaboratory comparisons of performance and accuracy.

It works like this…

Laboratory sends samples to another external reference laboratory to perform the same assays. The goal is to achieve results within the standard range of the reference laboratory, thus meeting the clinical requirements for that test.

This process demonstrates the reliability of results and is a requirement for laboratory accreditation by ISO 17043:2010, ISO 15189:2012, and ISO 17025:2017.

Those are just a few examples of documents related to clinical and medical laboratories.

SimplerQMS laboratory quality management software allows you to handle all of your laboratory’s documents in one place, so you never have to worry about losing track of them again. It streamlines all documentation-related tasks, such as creating, approving, and implementing new SOPs, and many others.

Making your laboratory’s work easier than ever.

Types of Records

As we mentioned before, laboratory records are the written records of all data produced inside laboratories. This information is permanent and needs to be easily accessed in cases of audits.

Let’s see some examples to understand better.

Equipment Cleaning, Maintenance, and Sanitizing

Written records of major equipment related to equipment cleaning, maintenance, and sanitizing need to be included in individual equipment logs.

The report informs the proper time intervals of these actions to prevent malfunctions or contamination and must contain the date, time, product, and lot number.

Calibration Checks and Inspections

If the laboratory uses automatic, mechanical, and electronic equipment, those need to be routinely calibrated or checked. You must keep a written record of those inspections.

Let’s say your laboratory has a water purifier. It is necessary to routinely check ion and particle rejection rates and eventually change the filters. Each of these maintenance actions must be recorded and stored.

Equipment Identification

All major equipment used in the laboratory must be appropriately identified by a number or code to be traceable to a batch or test performed.

Control Testing

Laboratories need to establish specifications, standards, sampling plans, SOPs, or other laboratory control mechanisms required to perform the assays accurately.

It is necessary to record and justify the results and deviations of this control test.

Test Records

These kinds of records are the complete data from all tests carried out to assure compliance with specifications and standards.

Including a description of the sample received a statement of each method used in the testing, calculations performed, and staff signatures.

Imagine a laboratory receiving a dried blood spot sample from a newborn to process. A predefined analysis method is already in place in the lab, and control samples must be used alongside patient samples. After the test, the staff will sign off on the results.

Good Laboratory Practices (GLP)

Regulatory requirements from national and international agencies need to be available for the staff to consult.

One example is the GLP detailed in several FDA regulations, which we will discuss in the next section.

Information is the major product of clinical and medical laboratories.

Careful laboratory document control management with a modern electronic system is crucial to compliance and quality.

SimplerQMS document control software is a powerful tool to help you create all these mentioned documents and records and many others using document templates.

With SimplerQMS, all documentation is promptly available to your staff in a secure, cloud-based system. Allowing your team to easily access, modify, learn, approve, sign, and keep track of documents.

General Document Control Requirements

Laboratory document control is a mandatory process for clinical and medical laboratories to be accredited and follow regulatory legislation.

Some organizations, such as FDA and ISO, provide the standards and guidelines that companies need to ensure their good management and quality.

Let’s have a look at the requirements for laboratories.

ISO 9001:2015

We know that ISO 9001:2015 standard is not exclusive to laboratories, but it is the general requirement for a quality management system. And any company committed to quality can see it as a strategic decision to improve the overall performance of all activities.

This ISO represents better customer satisfaction by improving processes, addressing risk, and evidence-based decision-making.

ISO 17025:2017

ISO 17025:2017 standard outlines the requirements to prove the laboratory has the knowledge and skills to test and calibrate equipment.

A facility accredited with this ISO can generate valid results with competence, impartiality, and consistent operation.

ISO 15189:2022

Based upon ISO 9001 and 17025, ISO 15189:2022 is the international standard clinical and medical laboratories can use to develop their quality management systems and assess their own competence.

So, in it, we can find the requirements for:

• QMS
• Quality manual
• Internal audits
• CAPA procedures
• Nonconformities
• Complaints
• Suppliers
• Environmental conditions
• Personnel
• Equipment
• Examination procedures
• Reporting of results

Recommended Reading: What is ISO 15189? A Detailed Introduction (and Role of eQMS)

ISO 17043:2010

ISO 17043:2010 standard specifies the requirements for proficiency testing.

However, it does not identify any particular fields of application for laboratories.

Clinical and medical facilities can test the same or similar items under predetermined conditions in interlaboratory comparisons.

21 CFR Part 58

Under 21 CFR Part 58 are the Good Laboratory Practices for nonclinical laboratories that research food and color additives, animal food additives, human and animal drugs, human medical devices, biological products, and electronic products.

Regarding document control, it guides:

• Personnel files
• Quality assurance
• Equipment maintenance
• Calibration files
• SOPs
• Notebooks
• Animal use documents
• Reagent labeling
• Protocols and final reports

You will need to keep this written material for two to five years.

21 CFR Part 211

The regulations in 21 CFR Part 211 contain Good Manufacturing Practices for producing drug products for humans or animals.

It states that laboratories must have written procedures for all activities related to drug production, assuring the identity, strength, quality, and purity of these products.

Furthermore, any deviation from the documents needs to be recorded and justified.

40 CFR Part 160

In 40 CFR Part 160, we find the GLP for laboratories conducting studies for pesticide products, such as insecticides, fungicides, and rodenticides.

Concerning the laboratory document control, this part is very similar to Part 58.

Clinical Laboratory Improvement Amendments (CLIA)

The CLIA is adjustments made to the Public Health Services Act by the US Congress over time. The goal is to ensure the accuracy and reliability of testing in all laboratories that test human beings.

The specific regulations to comply with CLIA are found in Part 493, as follows.

42 CFR Part 493

Laboratories must comply with 42 CFR Part 493 to be certified to perform testing on human specimens.

You will need to keep documents and records for two to ten years regarding all activities performed. Including, but not limited to:

• Certificate of compliance
• Certificate of accreditation
• Sample control procedures
• Quality control
• Quality assurance
• Proficiency testing
• Personnel files
• Equipment files

Of course, all these documents must be reviewed, approved, and signed by the responsible laboratory staff.

When dealing with electronic QMS (eQMS), the signatures can also be done electronically.

And for that, let’s see two more requirements described below.

21 CFR Part 11

The US FDA 21 CFR Part 11 outlines that persons may use electronic records instead of paper records or electronic signatures instead of traditional signatures.

The laboratory needs to use a system that allows for individual use of signatures, using identification code and password, which expires from time to time.

You can learn more about this topic in our guide about 21 CFR Part 11 software requirements.

EU Annex 11

This European regulation amendment, EU Annex 11, is responsible for the guidelines where a computerized system replaces a manual operation.

Regarding signatures, it is close to 21 CFR Part 11.

Moreover, having control of your documents is essential to achieve quality and compliance with all requirements.

As we learned above, a system for document control must include ways to:

• Create, edit and approve documents and records
• Promote training and learning for personnel
• Ensure documents are available to all
• Prevent obsolete documents from being used
• Limit access to confidential documents
• Facilitate document presentation during audits
• Retain documents and records for the specified period

SimplerQMS provides a document control software solution that is already fully in compliance with major regulatory requirements, such as 21 CFR Part 11 and Annex 11 regarding validation and electronic signatures.

With SimplerQMS, you can take full control of your laboratory documents, work more efficiently and make compliance easier.

Laboratory Document Control Best Practices

Now that we know the importance of laboratory document control to quality and compliance – let’s have a look at some of the best practices when dealing with these high-valued documents.

First, every document and record must be written in a straightforward, concise, user-friendly, and accurate manner to ensure anyone can fully understand the information.

Other best practices include:

• Keeping a chronological order of the documents
• Updating documents periodically, if applicable
• Sharing the most current version
• Implementing access levels and change control
• Assuring laboratory staff learned the documents
• Defining roles and responsibilities for the staff
• Making sure essential information is filled in (author, date, time, version, department, signatures)
• Following a workflow to create, edit, review, approve, share, update, and dispose of documents
• Storing documents in an orderly manner
• Retaining files for the proper length of time
• Implementing an electronic laboratory document management system

In the case of clinical and medical laboratories that use paper-based or hybrid document control systems, having these best practices in place is a great way to start improving document control.

The next step to optimize laboratory document control is implementing a digital solution.

Implementing a Laboratory Document Control Software

It is already clear that implementing a paper-based or hybrid laboratory document control system is not an easy task.

Especially using paper, you will need a vast and secure physical space, a lot of organizational skills, and a well-trained team focused on keeping documents in order. And even in the best situations, errors can occur, documents can be lost, and your team may struggle to access the files they need.

Today, the best way to have laboratory document control is through a designed system. Electronic QMS solutions with powerful document controls like SimplerQMS are an efficient, safe, intelligent, and least laborious way to ensure document control is being done correctly.

SimplerQMS provides an intuitive interface with comprehensive features and built-in support for regulatory compliance so that you can handle the requirements regarding document control and quality management.

Utilize the native integration with Microsoft Office and keep using the same program you already know. All documents and records are secure using a cloud platform for storage and readily accessible in one centralized place. You can attribute role-based access levels and implement digital signatures to control your documents fully.

To investigate whether investing in eQMS software with built-in document controls is the best solution for you, we recommend you download our free eQMS Business Case template.

An Excel spreadsheet with all the necessary information and calculations will help you understand the financial impact of investing in quality management software. And PowerPoint slides will give you inspiration for preparing the business case presentation to decision-makers.

Final Thoughts

You will deal with a high volume of data and information when working in a clinical or medical laboratory. It means a high volume of documents, reports, and all sorts of written materials.

Having control of these documents is critical to ensure the quality of work and compliance with national and international standards.

With laboratory document control software such as SimplerQMS, you will be able to manage all documents with an easy and clear mind that all standards and requirements are being met.

If any of this sounds appealing, book a demo and talk to SimplerQMS experts to streamline your document control processes!