An effective laboratory document control system is vital for managing a laboratory’s policies, procedures, and documentation. It keeps them up to date and accessible.
What is document control in the context of a laboratory?
The high volume of data and information in a medical or clinical laboratory creates a large quantity of documents, reports and written material. It is critical to control and manage these documents.
Laboratory document control is a multi-step process for approvals, distributions and revisions of documents. It helps guide a business to full compliance with national and international standards and regulations.
Standards that require document control
Laboratory document control is a mandatory process for clinical and medical laboratories to be accredited, and is required by these standards:
- ISO 9001:2015
- ISO 17025:2017
- ISO 15189:2022
- ISO 17043:2010
- 21 CFR Part 58
- 21 CFR Part 211
- 40 CFR Part 160
- 42 CFR Part 493
- 21 CFR Part 11
- EU Annex 11.
Laboratory documents and records
There are important differences and purposes between laboratory documents and records.
Documents communicate information and essential guidelines via policies (what to do), procedures (how to do something) and processes (how it happens). Documents must be updated constantly. They reflect the laboratory’s organization and quality management.
Records capture information and data (historical and objective facts) produced during laboratory tests, usually on worksheets, labels, forms and charts. This information is permanent and doesn’t need updating.
Records help in the continuous management of the quality system. They also help track samples throughout the process and identify problems. They must be maintained regularly; failure to do so reflects poor performance and disorganization.
This table lists some of the documents and records that are commonly used and required in laboratories.
| DOCUMENTS | ||
| Quality manual | Standard operating procedures (SOPs) | Controlled documents |
| Equipment maintenance | Personnel files | Instrument files |
| Calibration and calibration verification | Temperature and humidity logs | Quality control |
| Test tracking systems | Proficiency testing | Quality assessment |
| RECORDS | ||
| Equipment maintenance, cleaning, sanitizing and inspection records | Calibration checks and inspections for equipment | Control and test records |
| Equipment identification via a number or code | Specifications, standards, sampling plans, test procedures or laboratory control mechanisms | Patient records |
Document control best practices
Documents and records are essential for quality and compliance.
All documents must be written in a manner that ensures anyone can fully understand the content. They must be straightforward, concise, user-friendly and accurate. Adopt these best practices to ensure your documents facilitate quality and compliance:
Document control software for laboratories
Document control software helps a laboratory create all these essential documents and records. It simplifies and streamlines document control, increases process efficiency and enhances security.
Whether it’s a single laboratory or a multi-laboratory network, document control software makes integration and standardization easy. Staff can find policies and procedures immediately. If, for example, a revised version of a SOP for a particular piece of laboratory equipment is made, it can be accessed without delay using a controlled document.
Document control provides an automated, centralized platform for all document approvals, workflows, edits, sign-offs and audits, and more.
When document control software is cloud based, it eliminates the need for local IT resources or server space. Documents can be accessed by staff from anywhere in the world at any time.
How isoTracker’s software streamlines document control for laboratories
Paper-based or manual document control is time-consuming and can easily lead to dangerous mistakes in a laboratory. isoTracker’s document control software offers the automation necessary for a stable and secure quality management system.
The module integrates easily with the rest of our QMS software system to help laboratories create streamlined processes that all users can easily adhere to. Our software ensures that all documents are:
To learn more about isoTracker’s document control for laboratories, contact us online or sign up for a free 60-day trial.
