CAPA Software
TLM Corrective and Preventive Action (CAPA) software helps your company drive continuous improvement by orchestrating your employees through a regulatory compliant process of identifying, anticipating, and correcting nonconformances that might prevent your company from meeting customer requirements, while managing the possibility of introducing new risks.
TLM CAPA Software lets you:
- Drive continuous improvement.
- Maintain compliance and mitigate risk.
- Create a customized strategy for trend analysis.
- Automatic alerts of new CAPAs for real time collaboration.
- Supports multiple root cause analysis strategies.
- Vendors can respond to SCAR via secure email link.
CAPA Software
PLAN - DO - CHECK - ACT
- Create CAPA records through a structured workflow that ensures ISO/FDA compliance.
- Link your corrective actions to the necessary records from other modules.
- Custom fields and system settings allow the flexibility your company needs.
- Standardized reporting in real time keeps stakeholders informed in a timely manner.
TLM Quality Management Software – Turning the Complex into Simplicity
Corrective Action Software
Life just isn’t perfect, it is not a question of if something will go wrong, but when. Once a quality event occurs, your employees need flexible tools to both react and contain, as well as learn from each event so they can anticipate and mitigate future risks of non conformances. TLM Corrective Action Software provides the tools you need as well as the integration with other modules in order to leverage the CAPA software process and elevate its effectiveness to a truly holistic approach to corrective and preventive actions.
TLM Corrective Action software is both robust and flexible, yet ensures everyone is coloring inside the lines from a regulatory standpoint, which explains TLM’s track records of 100% ISO certification on the first attempt for companies using TLM.
Streamline a thorough CAPA process with TLM Corrective Action Software and find out why TLM is the highest value QMS software on the market today that helps your company deliver better product quality, safety and overall compliance and profitability.
Identify and Define the Problem
- Custom fields allow you to use meaningful terms or add customized data entry instructions.
- Management rep controls data options on drop down lists for accurate trend analysis data.
- Automatic alerts when there are new capas in your department.
- Flexible options to define containment plans.
- System setting controls to force at least two investigators.
- Define Containment activities, make attachments.
Understand the Problem
- Assign investigators and set due dates that roll up to the TLM Dashboard.
- Establish standardized investigation techniques/templates to support root cause determination.
- Automatic notification emails of CAPA tasks from your TLM Dashboard.
- Link the CAPA to vendors.
- Send vendors a secure link to respond directly into the CAPA comments for Containment, Root Cause and Action Plan details.
- Send the text of a particular comment into the Root Cause Field.
Determine the Root Cause
- Link the CAPA to a variety of other TLM records, such as vendors, equipment, employees, etc.
- Customizable trend analysis fields for insightful reporting.
- Supports a variety of industries with additional fields for Injuries, Police, and Security issues.
- 21 CFR Part 11 compliant electronic signatures for root cause investigator approvals.
Develop a CAPA Action Plan
- Describe the action plan at appropriate levels of detail.
- Link the action plan to attachments, the Event Module.
- Tracks the cost of quality.
- Customize the list of Event Module tasks in support of new CAPA Action plans.
- Integrated with MS Outlook and TLM Dashboard for Action Plan assignments and Due dates.
Follow Up and Effectiveness Review
- Establish effectiveness review plans.
- Integrated with MS Outlook and TLM Dashboard for effectiveness review assignments and due dates.
- Link the CAPA to a Risk and Opportunity analysis.
- Supports both single or multiple approval signatures.
- Tracks chronology of the CAPA events for traceability and accountability.
Easy Navigation with Fusion Technology Integration
Fusion Technology is what happens when information integration creates a higher-level management system beyond individual workflows. TLM CAPA Management 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.
Nothing Falls through the Cracks
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.
Why Do I Need to Conduct Corrective Actions?
Corrective actions is the system by which an organization manages the process of identifying and correcting issues that have or may result in nonconformances.
Historically they have been categorized as either corrective, in that a nonconformance has already occurred, or preventive, to address the risk of a nonconformance that has yet to occur.
- Preventive Actions – Let’s say you are monitoring temperatures of a food manufacturing process that is one of your HACCP critical control points and the fluctuations of these temperatures start to increase, but they have not yet passed the upper or lower allowed limits. This could trigger a preventive action investigation to determine if there is a root cause that needs to be addressed before those limits are breached.
- Corrective Actions – In this same example, if maximum or minimum temperatures have already been exceeded, then the response would include the containment and corrective actions in response to a nonconformance that has already occurred. This might include retesting or inspecting the lot/batch affected or discarding the affected materials altogether in addition to fixing whatever the root cause of the fluctuations were.
The corrective action process documents key activities during these events so that changes can be made in a controlled manner that do not introduce additional unforeseen risks, and has the best chance of addressing the root cause with the first change made to address the problem.
The other reason to document these activities besides providing the control to conduct them 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 CAPAs that involve a particular piece of testing or manufacturing equipment, vendor, employee, or part, trends might emerge that indicate an issue hidden behind what the initial root cause determinations were.
However, producing reports on historical trending data requires the use of software, like TLM Corrective Action software, to avoid the pitfalls of manual and duplicate data entry.
In addition, TLM Corrective Action software allows you to initiate CAPAs from other QMS events that might expose the need for them. This could be from internal audits, controlled documents, non-conformance reports, management review meetings, just to name a few.
Motivate Employees to Excel
Of all the factors that drive human behavior, whether positive or negative, none are as universal as the need to evolve, 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 Corrective Action (CAPA) module is one of the key tools for their success in this effort.
By organizing key aspects of how work is done, to include internal procedures and how employee job descriptions and responsibilities are defined, managers can use the CAPA process to empower employees to participate in finding opportunities for improvement, while maintaining approval control to ensure additional risks aren’t introduced by the proposed action plans.
TLM CAPA Software ensures these efforts are well organized, linked to all other aspects of the QMS that might be related, and assigned to ensure employees who rise to the occasion can be recognized accordingly.
There is Only One Type of Quality Management System
Yours!
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 quality management solutions 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 quality management solutions 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.
TLM Workflow Support:
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
TLM Delivers Your Solution
Out of the box, or with a few customizations, our QMS Software is backed by a 100% success rate for over 2 decades getting companies ISO certified on the first try!
If you have any questions or want more detailed information, do not hesitate to call us (866) 209-6896.
“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
“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
“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
Quality Integrated with Efficiency
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