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Deviation Software For Your Documentation

Deviation Software

Deviations from the approved procedures in your document management system can potentially affect quality, and therefore, regulatory compliance. Also called out-of-specification (OOS) results, deviations can occur during raw material and finished product acceptance, sampling and testing, manufacturing, or product distribution.

While it is impossible to completely avoid deviations, ISO and/or FDA-regulated companies, especially pharmaceutical, biotech, and medical device companies must have the ability to manage both planned and unplanned deviations.

  • Link to a location in the Contact Manager module to support supplier quality tracking.
  • Automatic linking to 13 other modules in The Lean Machine.
  • Deviation tasks are rolled up to the user dashboard.
  • Multiple date ordered investigation notes.
  • Email reviewer list via MS Outlook.
  • Multiple person approval list.
  • Six customizable text fields for relevant data entry.
  • Trend reporting and analysis tools.
  • Revision specific links to both Procedures and Parts.

Deviation Software

The Foundation of Your Digital Landscape.

If you are in a regulated company, such as pharma, biotech, medical device, or diagnostics, your company will be subject to the FDA or ISO requirements that will require the documentation and approval of any deviations.

So what is a deviation, and how is a deviation different from a non-conformance?

The answer is fairly straightforward as a deviation addresses an activity, whereas a non-conformance addresses a result.

So if your procedure indicates that raw material be treated in a centrifuge for 15 min, but due to some unforeseen event, it was only run for 12 min, then that would be an unplanned deviation.

If the final inspection of this batch was still within specifications, then no problem.  If it fails final inspection as a result of the deviation, then that resulting batch would be considered a non-conformance.

While there is some controversy around the idea of a planned deviation, intentionally deviating from a documented process, is another category of deviation commonly seen in manufacturing companies.
  • Use System Settings to customize how this module performs.
  • Linked to 13 other TLM modules for seamless integration.
  • Record Lot or Serial numbers affected.
  • Supports Multiple extensions of original time period if needed.
  • Make multiple attachments for supporting details.
  • Custom fields allow you to use meaningful terms or add customized data entry instructions.
  • Rename the module and customize deviation types to include other record types, such as “Notes to File.”
  • Uses the same customizable trend analysis fields as CAPA Module.
  • Trends can be reported on specifically or combined with CAPA data.
  • Gain insights with both graphical and meta data reports using customizable filters.
  • 21 CFR Part 11 Compliant signatures throughout all TLM Modules.
  • Risk based action tracking to meet traceability requirements.
  • Validation Documentation available.
Fusion Technology is what happens when information integration creates a higher-level management system beyond individual workflows.  TLM Deviation software incorporates this technology by integrating with other TLM solutions to create a Total Lean Management Software approach that provides all stakeholders with a picture of inter-related QMS events across your entire organization.

It also serves to create the foundation of your company’s digital landscape which saves you as much as possible from purchasing disconnected stand alone software, and provides the technical support for integrating other information systems when necessary.
All TLM software modules are rolled up to a user specific dashboard and summaries of each user's dashboard can be automatically emailed to ensure QMS activities are scheduled and prioritized accordingly.

In addition, the TLM dashboard helps users navigate to where tasks are performed, making it easy for new users to adopt the software without having to pay for extra training before being able to put TLM software to work for your company.

Having accurate records of both planned and unplanned deviations will help your company not only comply with various standards or regulations, it will also provide important information that might be related to incidents or continuous improvement efforts.

  • Incidents - Let’s say a customer has been experiencing some issues with a medical device that they have received/purchased. Using the part number you can research if any deviations may have occurred during the manufacturing of this device that might be relevant to the customer’s issues.
  • Continuous Improvement - During the regular review of manufacturing work instructions or procedures, one of the review steps could be
  • Regulatory Compliance- Depending on your industry, ISO and/or FDA standards will require you to have a functioning deviation system in order to manage the risks associated with not following an approved and released procedure.

The Deviation process in TLM documents key activities during these events so that products can be monitored in a controlled manner and additional unforeseen risks can be anticipated and avoided, or promptly found and corrected.

The other reason to document these activities besides providing the control in a systematic fashion, is to provide key historical data for trend analysis.  For example, if during the course of a year, there is a high percentage of deviations that involve a particular component, part, or procedure, trends might emerge that indicate an issue hidden behind design, production, servicing, or customer support, that was not known to the management team.

However, producing reports on historical trending data requires the use of software, like TLM Deviation software, to avoid the pitfalls of manual and duplicate data entry.

Of all the factors that drive human behavior, whether positive or negative, none are as universal as the need to evolve, and the resulting satisfaction in being a contributor towards positive change, whether we are conscious of it or not.

Your management team can create impressive organizational growth by harnessing this basic element of the human experience and the TLM Deviation software is one of the key tools for their success in this effort.

By organizing key aspects of how work is done, managers can use the Deviation module to empower employees to participate in finding opportunities for improvement and customer satisfaction while maintaining approval control to ensure additional risks aren’t introduced.

TLM Deviation Software ensures these efforts are well organized, linked to all other aspects of the QMS software that might be related, and assigned to ensure employees who rise to the occasion can be recognized accordingly.

Historically the decision to implement ISO was driven by the consequences of NOT being ISO certified when competitors were using ISO certification to win new business from customers who needed confidence in their supplier’s ability to consistently meet requirements.

This resulted in a lot of paper based systems set up by various “consultants” that advocated vague procedures that could technically meet the requirements of the ISO standard, but in reality did very little to improve quality or any other aspect of the business.

Times have changed, and the introduction of QMS software allowed organizations to take a different approach to their quality system and instead of wasting tons of time and money for little benefit, they are using their QMS to improve all aspects of the business.

At least the companies who could afford the high cost of most QMS software.

The whole point of ISO based quality standards is to address the minimum risks across every aspect of the business that could have consequences to customer satisfaction.  Unfortunately, by calling them “quality” standards, a misperception developed over the years that caused managers to think of quality as something the “quality department” was responsible for.

Total Lean Management (TLM) Software corrects this misperception by acting as an integrated management tool not only for compliance, but as the framework for how a company evolves.  Audit management software can be a vital component of this evolution, provided it is integrated with all the other aspects of the business to make auditing easier, faster, and more insightful.

There is Only One Type of Quality Management System


Over the last 20 years TLM has discovered a very basic truth when it comes to information management systems such as your eQMS, no two companies have the exact same needs.

In fact, the two biggest risks in the software selection process is either selecting software that is not flexible enough to manage information that is unique, and important to your workflow, thus forcing work arounds, or other concessions that effectively add waste to your business.

The other mistake is getting stuck with comprehensive, but inflexible systems due to their web based cloud hosting design, which forces a one size fits all approach to meeting customer needs.

And while one size might fit some, it might not fit all your needs when in the long run your understanding of those needs evolves and improves.

Total Lean Management Software, by definition, recognizes this fact, and addresses it through a dual technology, upstream / downstream user landscape approach to meeting the needs of both your upstream and downstream user types.  This is combined with our tiered approach to addressing newly discovered customer needs, making sure the software works in alignment with your business systems the day after your purchase, and for all the years ahead.

These measures include:

Custom fields

Allows you to adapt the software to your company’s terminology.

System Settings

Allows you to choose which features are applied to your process.

Rapid update cycles

Incorporating employee feedback into the continuous improvement cycle creates a synergistic effect on moral, engagement, and productivity.

Development Projects

This capability provides insurance that your system will never leave you stuck after discovering unknown needs after implementation.

High levels of interlinking

By implementing and combining modules in way that might be unique to your business or work flows.

World class customer support

Evolution is a team effort, and the whole team behind TLM enjoys helping companies comply with regulations, manage risk, continuously improve, and maintain a steady growth rate.

Help Files can be Linked to your Controlled Work Instructions

This unique TLM feature allows you to link individual screens in TLM to your own controlled procedures or work instructions for that area of the software (if needed).

Why TLM is your Best QMS Software Choice

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If you have any questions or want more detailed information, do not hesitate to call us (866) 209-6896.

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TLM Customers are always our top priority -David Smithstein, CEO

“In the 10 years that we have relied on TLM to manage our quality documents, it has grown to become the core of our QMS. Our QMS has been audited by BSI, TUV, SAI, FDA, Canada Health and CDPH . We survived all of those audits and emerged a better company. Thanks, David!”

Jim Klett

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“EXCELLENT customer service! Without fail, David has responded to every question, email and phone call within a few hours. He is great to work with and always willing to help… TLM is a one-stop shop for all of our QMS needs … The training videos on the website are helpful- keep them coming!”

Allison Getz

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“Very helpful in fine-tuning the software/reports to meet our specific needs for audits, even ones requested the day before the audit. The software is straight forward for use, we have 8 personnel in two different locations using it seamlessly … The best customer support I have ever used.”

Stewart Denham

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