Key Factors when selecting an electronic Quality Management System

Key Factors when selecting an electronic Quality Management System

1. Compliance

How does the proposed solution work within the scope of 21 CFR Part 11 and/or Annex 11?

Any electronic Quality Management System (eQMS) that is marketed for the Pharmaceutical industry will have built-in functionality to meet the requirements needed for compliance. However, if the solution is not designed for pharmaceutical companies, the question of compliance should be raised early in the selection process. An evaluation must be completed to ensure a compliant approach will be achievable and to determine whether it is sensible within the cost and time constraints of the planned implementation project.

If the Quality Management Systems that you’re considering are scoped for pharmaceutical industry, be sure to think about the validation cycles required for hosted or SaaS model solutions. Will your users be available for testing? Will the business be accepting of outages and down time to support regular deployments of new configurations? Who will be responsible to analyze and accept the defined risk for upcoming changes?

For any eQMS implemented for your business, the question of upgrades will regularly arise. Those solutions on the hybrid cloud or SaaS model will prompt a more urgent response to the question of validation as there are vendor release cycles to observe. The business will need a dynamic, responsive risk-based analysis and assessment of changes and quick turnaround of the validation/verification actions to maintain the validated status of the system. This is certainly not an impossible task as so many businesses use SaaS solutions, but it is an important area to evaluate and plan for when deciding which solution to choose.

2. Scope

What information and data does the business need the eQMS to manage? The various solutions offered can accommodate some, or all, Quality Management areas for the business. In most cases, the business can decide the extent of those areas that will be managed within the eQMS. Consider whether all existing Quality solutions should be incorporated into a single solution, or if the new system should start small and expand to other areas over time. Look to identify the processes with the largest pains in place currently; a clue for identifying those processes is to look for the overall time it takes for the records to close. Industry standards for Change Control, Deviation, and Audits will provide a benchmark for how well you are keeping to the schedule. If these quality management actions are regularly falling outside of these benchmarks, it could signal that the process needs some improvements, and those improvements can often be realized by implementing an electronic system for managing the events.

The ability to manage supplier quality is also something that many of the solutions offer. Either through an oversight process or by allowing the supplier to log on to your solution to create quality-related records – this functionality can help to alleviate some time-consuming processes in the business working with suppliers.

Another scope related question is that of the platform’s ability to support business areas that fall outside of the immediate quality-related focus. For example, Supplier Audits can often signal the health of the relationship with that supplier. Regularly failing a supplier during an audit can alert the contracting department, prompting updates to existing contracts or even termination of a contract, or suggesting qualification of an alternate supplier. Similarly, managing status changes for releasing batches of products can be automated to ensure that unreleased products or products requiring investigations remain on hold status.

Identify the departments and sites that will be involved in the process to implement, and most of all, in the use the future eQMS. The application might only apply to some sites depending on the actions taken at those sites, so it is better to avoid opening up too many new topics while you are just starting out. Also be sure to include stakeholders from the beginning so that they won’t be surprised with the finished product. Last minute updates to their processes or their migration activities can be a disaster.

3. Transferability

What is the approach for transferring existing eQMS data and information? Consider that once you select an eQMS and are ready to start the implementation process – the ability to bring your existing data and records into the new system might be another decision point. There is always a way to accomplish this type of migration, it is a question of whether or not there is sufficient value after go-live. Some considerations include whether the system can easily accommodate existing records: is there enough metadata to support the base requirements in the future eQMS or will additional enrichment or system configuration changes be necessary to support importing this information?

In the event a new site is added to your company, how will the eQMS adapt to new processes, users, and data? Implementing a system to meet known requirements can be attainable, however if the system is not scalable or flexible to accommodate future business, you might end up in a place where you will need to select a new eQMS and repeat the process once again.

Also, what happens when you add a new product to or divest a product from your portfolio? Will it be straightforward to update the eQMS? Or will you need to allocate time and material to the efforts? How will this change affect the validated status of your eQMS? Just to list a few of the considerations.

4. Maintenance/Upgrade paths

When implementing any software solution, it is important to assign and spread responsibilities to make sure that none of your team members will be overloaded. Consider where the responsibility would lie for the software maintenance. Who will solve infrastructure issues? Who will maintain user access and group membership? Who will plan and implement the upgrades? What impact will upgrades and maintenance have on the business? What effect will the upgrades have on your end users? Who will train the users on new functionality? Who will decide which functionality to turn on or validate?

5. Cost

Last but not least, of course one of the top considerations for your financial team will be the cost of the solution. Even in this area there are multiple options to consider, the most obvious difference is a one-time license (with annual support engagement costs) versus a subscription model. Both models have benefits and drawbacks, so consider the following questions when evaluating:

  • One-time License payment
    – Are the user counts consistent?
    – Does the business have resources available to support the infrastructure?
    – Will the business users be satisfied with a less agile solution and patient for upgrades/improvements
  • Subscription model:
    – Will the validation resources be available to maintain the validated system status?
    – Does the business prefer a more dynamic solution with new features released regularly?
    – Does the business support training users on new functionality with the software releases?

There are quite a few factors to consider when selecting the most fitting eQMS for your business. Evaluating the benefits, risks, and on-going maintenance requirements for the available solutions is not an easy task. But defining the different considerations and evaluating the options available against a uniform set of criteria, can help your team to select the best fitted solution to enable your business to manage patient safety and product quality with a successful outcome all around.

About the author

Alicia Whitney has been working with compliant, validated computer systems since 2010 when she started her career at a small pharmaceutical company in Pennsylvania, USA. Collaboratively implementing and validating document management, quality management, and inventory management systems, she has gained knowledge and experience in many areas of the pharmaceutical industry. Since joining fme Life Sciences in 2018, Ms. Whitney has continued to provide an experienced perspective when gathering requirements and guiding assessments for client implementations. Ms. Whitney continues to build on her experience, now holding certifications on TrackWise Digital QMS and VeevaVault Platform.

fme Life Sciences is a leading provider of business and technology services supporting the deployment of Content Services and ECM solutions to its clients in the Life Sciences Industry. We act as a trusted advisor and systems integration specialist across the Clinical, Regulatory and Quality and Manufacturing domains in Europe and North America. We do not exclusively recommend or promote any platform or vendor, but rather we focus on providing our clients with an independent perspective of the solutions available in the market.
Why Do You Need an Electronic Quality Management System (eQMS)?

Why Do You Need an Electronic Quality Management System (eQMS)?

1. Increase the quality of your processes while saving time and working remotely if needed

“Paper processes have always worked fine for us…” is a common objection when it comes to discuss introducing an eQMS. Yes, paper is an improvement over previous tracking methods: memory, stone tablet, bamboo. However computers can be trusted as well , and are quite a bit better than these tracking methods. Plus, there are additional capabilities that an electronic system provides. For example, the eQMS can include validation checks to improve the proportion of right-first-time entries, requiring fewer revisions and eradicating errors commonly encountered with paper processes.

One of the most valid reasons to move away from paper processes surfaced in the recent, sudden need to shift to remote work. Some work must be completed on-site (such as any true manufacturing related tasks), however supporting actions for these tasks may be handled remotely. Implementing an eQMS can support these tasks in a more streamlined, compliant, and user-friendly manner than any of the ad hoc solutions that likely had to be brought in place in short order to support the recent in-office interruption.

Finally, eQMS solutions can also save time for the end users; pre-populated picklists, system-calculated dates, and the ability to clone existing records, are all basic out-of-the-box actions in the typical eQMS. Once implemented, the eQMS will free up your users to think about the actual work that humans are required to complete, like the five-whys of any quality event. Instead of issuing tracking numbers for each event, all of the eQMS solutions are able to assign unique IDs to records right when they are created. Manually managing Change Control numbers with a logbook will be an easily forgotten memory.

“If you didn’t document it, it didn’t happen.” How often have we heard that mantra? Electronic systems have benefits of requiring users to enter certain information or select pre-defined values for a field. Combined with the standard audit trail functionality included in the eQMS solutions, traceability for any action logged within the eQMS is a snap.

2. Guaranteed security, back-up and availability of your business critical data

“Storage of paper records is not a problem…” is what I often hear my clients say. Paper records need to be retained for years past the expiration date of batches produced, and need to be held on-site or at a storage supplier who needs to be qualified, paid, and regularly audited. Even when the most careful approach is taken, incidents still can occur and there is no path to regaining those original documents.

Some businesses rely on SharePoint or file directory storage for maintaining documentation instead of paper records. Certainly this is an improvement over the physical paper copy, however managing access to the different SharePoint locations and the unmitigated disorganization of end users creating their own folder structure or guessing where a document should be stored can create a nightmare scenario for upgrades, re-organizations, or the divestiture or acquisition of specific areas in the business.

eQMS Systems provide a level of confidence in the ability to maintain themselves without the need of an additional disaster-proof location. Server rooms are already part of the standard disaster recovery plans and backups are taken regularly to ensure business continuity. Alternatively, the leading providers of eQMS Systems for the Life Sciences industry all offer hosted options for your environment, with insurances and assurances that your data will be secure, backed-up, and available to you whenever you need access.

3. Accelerate Annual Product Reviews (APR) or Product Quality Reviews (PQR)

“Tracking, Trending, and reporting using paper records is well-managed in a spreadsheet…” – another frequent misconception in this context. Preparing Annual Product Review (APRs) or Product Quality Review (PQR) with a paper eQMS is time consuming. Gathering real-time data to support business decisions can be challenging.

Reporting has never been easier using an eQMS. One-click reporting solutions that are highly configurable and easy to set up by business administrators can cut through the data to help you know where the holdup is in your processes. Systems also provide the option to send automated emails to the interested parties, which can even be sent to external partners helping with supplier management and transparency of identifiying existing or potential issues.

Trending is also easier in an electronic system. Rules can be set up to notify specific users/groups or even take actions on behalf of a human, like opening an Investigation for multiple Out of Specification (OOS ) events logged for a specific lot of product.

4. Meeting regulatory compliance expectations

“Data Integrity isn’t a concern on paper…” – Have you also used this argument? If you didn’t document it, it didn’t happen. Paper processes can be rife with errors, or omitted data. Electronic systems compel the users to enter the necessary information before the user is allowed to progress to the next step. Effective system design combined with OOTB audit trail functionality in the eQMS solutions alleviates many paper process data integrity issues before they can occur. The audit trail is presented as a robust report, including all of the applicable data about who made a decision to move forward and when the decision was made and what the justification for making the decision. The Audit Trail functionality has been developed as a part of the best practices to meet regulatory compliance expectations. And as such, auditors are more familiar with the solutions and less time is spent looking into the functioning of the system.

In summary, implementing an eQMS for your compliant life sciences business provides a number of beneficial results. Value in the implementation of and eQMS will be found in greater efficiency, fewer errors, and major improvements in reporting. Beyond these improvements, many more opportunities are available including integrations with other systems, improvements in user access and manging user acces, and the potential to incorporate paper processes from other parts of the business. Please find more information on our website.

About the author

Alicia Whitney has been working with compliant, validated computer systems since 2010 when she started her career at a small pharmaceutical company in Pennsylvania, USA. Collaboratively implementing and validating document management, quality management, and inventory management systems, she has gained knowledge and experience in many areas of the pharmaceutical industry. Since joining fme Life Sciences in 2018, Ms. Whitney has continued to provide an experienced perspective when gathering requirements and guiding assessments for client implementations. Ms. Whitney continues to build on her experience, now holding certifications on TrackWise Digital QMS and VeevaVault Platform.

Checklist for a Successful OpenText Documentum D2 Implementation

Checklist for a Successful OpenText Documentum D2 Implementation

After all, the sheer volume of content can be overwhelming and the potential to change business processes that developed over time can be a contentious point in any organization. This planning checklist can assist in making the transition as painless as possible and put your organization one step ahead in planning and implementation.

1. Know your workflow processes, but be adaptable
While Competent Authorities have specific requirements around the development, manufacture, and maintenance of drug products, drug substances, and medical devices, the specific business processes to meet those requirements are not explicitly defined by the Authorities.Companies generally develop processes to comply with the requirements and still provide an efficient flow to ensure the product/device can be supplied to the market. While your business processes may have been developed specifically for your company, certain efficiencies can be gained by broadening requirements and adopting the best-practice solution provided by OpenText. By adopting a future state business workflow that aligns with the best-practice models supplied, you can take a smarter and faster approach to your implementation, allowing your implementation partner to focus on other, higher-value customizations that will benefit your business.

2. Familiarize yourself with the DIA reference model
The Quality & Manufacturing solution has been developed with the DIA reference model as its backbone. This industry-supported model outlines an organizational structure for documentation. OpenText Documentum for Life Sciences Quality & Manufacturing module leverages this model to provide an out-of-the-box solution that can manage 95 percent of your documentation. You can derive maximum value from this model by identifying artifacts that closely align with current documentation and by adopting the DIA terminology. If necessary, additional artifacts can be added in the Quality & Manufacturing solution with consideration for validation and documentation effects.

3. Define templates
Content creation is the function of your authors. Using templates for the content ensures uniformity across the solution and makes your review team more efficient, allowing them to focus on continuity of content, rather than on formatting. OpenText Documentum for Life Sciences Quality & Manufacturing module provides the ability to associate templates with each artifact name, if desired. Templates that are imported into the system must be approved before use in content creation, allowing control over the formatting and structure of content authored in the system.

4. Know your users’ roles and functions
OpenText Documentum for Life Sciences Quality & Manufacturing module provides a site-based, role-based security model to save time and effort in determining how to set up security. The combination of membership in site and role allows the business to limit access to content, as needed while permitting appropriate individuals to perform certain business functions. Roles provided by the solution include author, reviewer, approver, quality organization approver, coordinator, and administrator. By identifying the users who fit these business roles early on in implementation, you can accelerate the system set up and provide very focused communication and process training to the impacted roles.

5. Identify your system champions
Implementing OpenText Documentum for Life Sciences is a significant change, whether moving from a paper process, a previous Documentum system, other software system, or even a previous version of the solution. The best approach to building positive momentum is to identify a small group of users who will learn the system first and act as change-makers and champions of the new system. This will go a long way to support the overall user adoption. Of course, user training is paramount to system adoption and a positive impression of the system’s capabilities. Beyond that, a core group of champions for the software can initiate a wave of excitement for the new system. Change in any large organization can be challenging, but change combined with a learning curve presents two significant hurdles. By anticipating the challenges and preparing your processes and people in advance, organizations can positively promote change and work through many of the challenges presented by those learning curves.