10 Key Steps for Implementing a QMS


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Any electronic quality management system (QMS) evaluation project should be seen as an opportunity to improve quality within your organization. Like all projects, there are a number of steps needed to ensure that the preparation, implementation and rollout are a success.

#1 Carry Out an Internal Organization Audit

Taking an inventory of the current system is a vital step before investing in any costly long-term project. All quality management processes, from document management to concrete processes, need to be analyzed thoroughly. The audit provides an idea of the quality system's strengths and weaknesses; it can also help determine how well it aligns with regulations and standards that the company needs to follow. The results of the audit can be used to draft measures to optimize agility, conformity and profitability.  

#2 Measure ROI

Return on investment (ROI) is a key metric for decision-making and gives an overall idea of the project's performance. There are free online tools that you can use to estimate the short- and medium-term costs of integrating a QMS within your company. Calculate your ROI.

#3 Get Stakeholders Onboard

There's no point in having an approach to quality in place unless it's supported by management and implemented by all staff. In order to make sure everyone's committed to the project and to avoid cutting corners, key decision-makers need to know far enough in advance. This step needs the management team and quality manager to use all of their professionalism to sell the plan to C-level executives, the board, the IT manager, their teams, and anyone else involved.

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#4 Set a Policy and Objectives

An important aspect of a quality approach is to clearly define a policy and articulate it as specific and concrete objectives. Communicate about what you are trying to achieve to help everyone understand the reasons of the change. Potential objectives might include:

Commercial objectives

  • Improve customer satisfaction
  • Increase market access
  • Expand the company footprint
  • Bring new added-value for product effectiveness and safety
  • Increase responsiveness and competitiveness

Internal objectives

  • Optimize operational efficiencies
  • Implement a lean quality management plan
  • Integrate complete traceability
  • Deliver greater visibility on quality processes
  • Improve assessment and quality control
  • Ensure regulatory compliance
  • Reduce costs
  • Enhance the culture of quality within your organization

The quality strategy can be turned into a pitch for the primary stakeholder, serving as a roadmap throughout the implementation. It gets everyone working together in the same direction.


#5 Create a Team to Steer the Project

Once the quality goals have been established, the next step is putting a team in place to guide the project to completion. In most cases, the head of the project (typically the individual championing the project) will be from the quality or IT department, making it vital to involve staff from a range of other departments to ensure that the project gets broad-scale buy-in from those it will affect. Roles and responsibilities of team members will be defined based on each member’s individual expertise.

#6 Assess the Requirements and Draw Up Technical and Functional Specifications

Performing a detailed analysis of the current quality system will help assess your company’s requirements so that you can take actionable steps toward the implementation of new quality management software. A quality software implementation plan implies selecting the appropriate field-based software system modules from the software’s solutions suite that best fill your organization’s needs. You’re then ready to draft technical and functional specifications, including all project milestones.

#7 Choose the Software

With your company's requirements delineated, it's time to choose the most suitable software solution. Key factors to look for are:

  • Functionality: By looking at the scope of the solution, you can ascertain whether each candidate solution meets not only your organization’s current quality needs, but also future ones. It's important that the modules offer powerful functionality, but even more, that they are integrated. For example, you could use a confirmed customer complaint as a basis to generate the necessary non-conformance, and then launch a corrective and preventative action (CAPA) to resolve the issue. The CAPA process can create a request to update the document and/or schedule staff training. None of this works unless the non-conformance, CAPA and electronic document management (EDM) modules can connect with each other. In sum, productivity should be a primary factor when choosing software.

  • The Software's Operational Power: A QMS can reduce the time it takes to locate documents, improve access and sharing of documents, and increase data security, just to name a few.

  • Updates: The software solution providers should provide regular updates to ensure that your system always remains compliant with changing regulations.

  • Support: When relying on an external partner for services, such as software validation, maintenance, and user training, it's always important to make sure that the supplier also offers expert support from specialists in the field.

  • Software Validation: Life sciences companies are required to integrate a validation step that complies with regulatory requirements. The ISO 13485:2016 standard states that this needs to encompass software validation. Validation is needed throughout the software's life cycle, from the start of the project and throughout implementation. When choosing your automated QMS, make sure that it's designed for trouble-free validation, such as having an authentic electronic signature and an audit trail with full traceability and segregation of duty rules. You should also check that the software provider offers validation record and data integrity guarantees. These are all huge plus points.

MasterControl offers a customizable eQMS solution for automating, managing, monitoring and analyzing your quality processes from a single central interface. The integrated MasterControl software suite has modules that tie in with each other for automated management. MasterControl QMS solutions protect your data throughout the data life cycle, automate quality management processes, and offer transparency and traceability of all events. As the official MasterControl distributor for the French-speaking world, Apsalys supports its clients throughout their electronic QMS project implementation experience to guarantee your success.

#8 Deploy the System and Migrate Your Data

Deployment involves integrating the QMS within the IT system, including any required external connections, such as with an enterprise resource planning (ERP) tool, a laboratory information management system or a product life cycle management system. There are a number of options for installing the software. It can be installed locally on the company's servers, hosted on a dedicated remote server, or provided in the cloud as SaaS. Another thing to consider is the type of license required, depending on how the software is being used. License options include:

  • Named user licenses, which can only be used by one person and can't be shared.

  • Concurrent user licenses can be used by multiple users, but only one of them can connect to the software at any given time. This option allows a single license to be shared by several users, reducing the licensing costs significantly.

The right hosting and licensing model will depend on the project's deadlines and budget.

#9 Adjust Settings

Once the software is installed, it's vital to adjust the settings to tailor it to your company’s day-to-day requirements. At this stage, it's still possible to add or customize modules based on the needs identified. This is also the point where existing data needs to be collected and migrated to the software's database.

#10 Train the Users

Training is a crucial step, and its duration will depend on the number of modules and their timeframe for implementation. A tailored training program is the best way to make sure the software is used correctly; by learning the software one module at a time, good practices can be steadily become ingrained habits and policies. By checking knowledge gained by users, such as through online test training and exam, it's possible to ensure that key functions of the software are used properly. Users can be taught how regulations and standards are built into the software, meaning that using the software makes more sense to them and becomes easier to use.

Don't hesitate to contact Apsalys, the official MasterControl partner and distributor for the French-speaking world, if you have any questions about your electronic QMS project. For more information, visit www.apaslys.com



2018-bl-author-tifany-desprezTifany Desprez
 has joined Apsalys as its communication and marketing manager. She graduated in 2015 with a doctorate degree in neurosciences from the University of Bordeaux in France and worked as an assistant in communication at Bordeaux Neurocampus. Desprez continues to develop her interest in scientific innovation and information exchange in business access to life science organizations. She enjoys connecting with other life science industry professionals to gain insights about compliance and quality challenges. Desprez can be contacted at t.desprez@apsalys.com.