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.

Managing CRO Sponsor Compliance in Veeva Vault Clinical

Managing CRO Sponsor Compliance in Veeva Vault Clinical

We also highlighted the importance of having a full picture of your outsourcing strategy as a small-to-midsize clinical research Sponsor. The activities to be performed and the systems of record to be utilized by the Contact Research Organization (CRO) drive our approach for oversight and governance – the essential compliance aspects of eClinical systems in the clinical operations space.

For example:

  • Will the CRO use their in-house eTMF system, work exclusively in the Sponsor eTMF, or a combination of the both?
  • Will the CRO systems/reports integrate with the Sponsor CTMS to capture enrollment metrics or other pertainant, strategic clinical data points?
  • What is the cadence of document and information sharing expected (i.e. Quarterly, Annually, End of Study)?

With this healthy foundation – simplicity and awareness – we are primed to tackle two key components of long-term eClinical system success: oversight and governance.

Oversight doesn’t have to be a complex process

First, let’s box in exactly what a Sponsor is obligated to under the FDA requirement of ICH E6, Section 5.2:

5.2 Contract Research Organization (CRO)
5.2.1 A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.

The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).

Put simply, the Sponsor must ensure that there is appropriate oversight and the evidence of the oversight needs to be retained. If the CRO didn’t do something or didn’t execute in the agreed upon manner or timeframe („specified in writing“ as required in 5.2.2), the Sponsor continues to bare the risk for the breach or underperformance.

As we can see in 5.2.1 of ICH E6, the CRO does have an obligation to implement (1) quality assurance and (2) quality control measures; as the Sponsor, these are our items of focus for oversight.

Is the CRO executing in alignment with these things:

  • Quality Assurance – the overarching quality management concept that relates to how a process is to be performed, and uses a proactive approach to prevent quality issues from arising
    (i.e. work instructions, process checklists, standards to be met in order to approve a document)
  • Quality Control – a reactive measure used to detect defects/deviations from defined processes and the steps taken to capture (documentary evidence of issue identification process and remediation steps) and correct any issues
    (i.e. mock inspection, QC Review workflows, logging Quality Issues on documents and routing for remediation).

Now that we know what is required, let’s talk game plan. Oversight doesn’t have to be a complex process – just set the cadence, determine the sample size, and, like your 3rd grade math teacher used to say, no points awarded unless you show your work!
Start with what is feasible, given the applicable outsourcing model and regulatory history of the organization (annual, staggered with Veeva Vault releases (3x yearly), etc.). Determine the subject matter to be reviewed and create a simple, user-friendly format to capture CRO oversight activities. This should include the remedial measures taken to correct any issues; to follow through with those measures is key, and should be incorporated into the next round of CRO oversight (if not completed sooner).



How to create a simple, painfree governance framework

Governance can be an intimidating concept! Given Veeva‘s 3x annual release schedule and associated impact activities for each one, where do you even start? The most common challenge that small-to-midsize organizations face is optimizing limited resources – how do you find the time to develop a strategic system management plan, create structure and process to support that vision, and then, actually execute on it?

The good news? In the exasperation, is the answer.

Let’s break it down:

1. Develop a strategic system management plan.

a. What we do now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

b. What we want to do 1 year from now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

c. What we want to do 3 years from now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

2. Create structure and process to support that vision.

a. What are we doing now that works?
b. What are we doing now that doesn’t work?
c. What needs to change to get us to the Year 1 goal?
d. What needs to change to get us to the Year 3 goal?

3. Execute on it.

a. Start with what is within your control. Lay the groundwork to persuade others toward your future vision, then embrace the evolution of the strategic vision.

By answering the above questions, you’ll create a simple, painfree governance framework; a good foundation from which to build and mature, tailored to your organization‘s specific goals and needs. And, if task 2 „Create a structure and process to support that vision.“ was a tricky one, not to worry. We’ll dig deeper into that specific topic in our upcoming blog post: „Data Discernment – A simplified approach to strategic planning“ – stay tuned!

About the author

Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.

Reducing the “noise” – How to tailor Veeva Vault Clinical to your individual needs

Reducing the “noise” – How to tailor Veeva Vault Clinical to your individual needs

With this blog article I am taking a closer look at how CRO Users and Activities are managed in Veeva Vault Clinical and deal with decision-making re: who from CRO can/should have access to eTMF/CTMS in Vault, what activities are performed in Sponsor vs. CRO eTMF, and how you can tailor the system according to your needs to avoid functional overload. In my next blog I will talk about Inspection Readiness – “Managing CRO and Sponsor Compliance in Vault Clinical” and part three will cover the topic of Integration and Reporting – “Data Discernment – A simplified approach to strategic planning.”

Moving to a cloud-based eTMF and/or CTMS is a big step, particularly for a small to mid-market life sciences organization. The budget to secure and implement eClinical technology typically coincides with a strategic shift by company leadership, often leaving clinical teams feeling pressured to support visibility and engage deeply in a new system. A key challenge is balancing the existing outsourcing model (spend, system integration, and study activities) with the capabilities of the new system(s).

How to find the right balance of streamlined configuration and intentional user access

Here are a few important questions to ask as you determine the right fit – a balance of streamlined configuration and intentional user access – for your organization:

First, do you know your outsourcing strategy? Learn it. Read the contract, request the scope of work or a synopsis thereof:

      • what is the CRO scoped to do?
      • is it on a study by study basis OR 80/20 consistent activities OR other?
      • is work done in CRO or Sponsor environment per the scope of work/contract?

Second, align the supporting documents:

      • what does the CRO Oversight Plan say about system work?
      • if there is no CRO Oversight Plan, make one.

Third, observe what is actually happening with your CRO partners:

      • is the CRO performing in accordance with the scope of work as it relates to system activities?
      • does this CRO user need the level of access that they have requested?
      • if not, what steps are being taken to communicate, mitigate, correct, and document?

Now that we know how the CRO is contracted, we can address what the Sponsor system should support. It’s challenging for many small and mid-size Veeva customers to effectively tailor their Veeva Vault experience to the actual work being performed in the Vault environment. Keep in mind that Veeva Vault Clinical is intentionally designed to support a broad customer profile – biotechnology, medical device, and pharmaceutical companies in ALL phases of research and commercialization, across ALL indications. The out of the box offering is powerful, dynamic and comprehensive, but can also be overwhelming!



Reducing the “noise“ – Tailoring the Veeva Vault Clinical environment to your individual needs

Of particular importance for small to mid-size customers is to tailor the Vault environment – not by adding new configurations, but by strategically turning off features that, while beneficial, act more as noise and barrier to end-user adoption.

For example, if you utlilize a full-service CRO (one that performs most study activities), a Sponsor CTMS runs the risk of capturing duplicitous, out of date data, not to mention the resourcing burden for Sponsor with ingesting superfluous data.

The key question here is: what data elements do I need as the Sponsor to support (1) compliance and (2) the strategic portfolio?

Many out of the box fields in Vault CTMS are not required for an outsourced Sponsor and may create more “noise“ than potential business benefit. If the CRO provides a weekly report or output from their CTMS, it may be more beneficial to integrate or ingest their data rather than utilize scarce resources to perform duplicate data entry, particularly if these data points are not currently actionable or used.

Features to consider:

    • Expected Documents / Expected Document Lists
      • Are we collecting the Expected Documents or is the CRO collecting, then updating the Sponsor eTMF (or sharing a weekly/monthly report)?
      • Can we eliminate or reduce the template EDL to better support our oversight activities, rather than duplicating work already done by the CRO?
    • Milestones
      • Are the template Milestones relevant to our internal processes?
      • If not, let’s turn them off or simplify the Milestone Template to align with our process and create a more useful, purposeful user environment.
    • Workflows
      • What document processes are actually taking place in our eTMF or CTMS?
      • Do we need all of the possible out of the box workflows available to users or is it causing confusion?
      • If we don’t need all available workflows, let’s turn them off so that users have only the relevant business processes available when actioning a document in the system.

The technology landscape puts capabilities at our fingertips, but just because we can do something doesn’t necessarily mean that it‘s the right thing, right this minute for our team(s). This simplified foundation provides a system environment primed for agile adaptation, rather than beginning from a place of overwhelm: start simple, then mature the system and supporting processes to meet your company‘s unique needs.

And, lastly, how to determine when to kick things up a knotch. Being intentional is of great importance, particularly in system management. We are the nexus point joining the limitless potential of modern technology with the business user experience. It is our role to facilitate clinical enablement, to make doing the work of bringing drugs, devices and biotechnology to market that much better – faster, safer, and more cohesive!

In our next post, we’ll speak to the unique needs of small to mid-size life sciences organizations as concerns strategic maturity and how that fits into a hybrid governance model, specifically designed to align with Veeva’s 3x annual release schedule. Stay tuned!

About the author

Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.

Keep Talking: Why Communication Is the Key to a Successful Project

Keep Talking: Why Communication Is the Key to a Successful Project

When an investment in IT solutions doesn’t live up to expectations, this can often be attributed to lack of effective communications and the establishment of a formalized communication plan. If the project is pushed through the various phases before the teams discuss shared expectations, what each phase includes, and the potential issues and anomalies that could potentially arise during each phase, the project has a high probability that it will go off the rails at some point.

To ensure successful project outcomes, project leaders must be good communicators. In fact, the Project Management Institute says the biggest part of any project manager’s job, consuming 90 percent of their time, is communicating.

Institutionalizing communications

  • Set clear objectives
    A successful communication plan should begin with clear objectives, milestones, expectations and even escalation paths should something go wrong. The rules of the road should be discussed and agreed to with the key stakeholders on both the client and vendor partner side. While it may seem obvious, it’s important to set up a clear and regular line of communication so team members can report project progress.
  • Develop lines of communication
    Project leaders can’t be responsible for every aspect of the project, so it’s important to delegate tasks and set up clear lines of communication so team members can quickly and easily report back on what has been accomplished, what’s outstanding, and where problems have arisen. And always share changes to any part of the project with all team members..
  • Establish a regular cadence for meetings
    Regular meetings are important to allow project risks to be identified and talked about. But since projects and teams are often dispersed across departments and even geographies, it’s of paramount importance to find a variety of ways to communicate effectively and to establish effective lines of communication that can help the project move along fluidly.

A Closer Look: Client Learnings

Let’s take a closer look at what can happen when communications are not part of the project plan from the start.

In a recent client project, we were moving swiftly from phase to phase in implementing a new system. The client’s project team had an aggressive timetable, and while we were aligned on the tasks for each phase, inevitably stakeholders would be asking questions at the end of each development cycle that indicated to us the proper communications was not established from the onset. It was clear that some key decisions or clarifications were taken by functional leads that didn’t take into account other regions or users of the future system.

Were they made aware how the schedule impacted them? Did they understand changes in processes? It was clear they weren’t.

We were able to leverage our experience and lead the client through an exercise to understand the impact on other regions/sites and the broader implications for their processes. While solidifying needs and requirements at the midway point of the project would impact the timeline and overall budget, the client understood the criticality in getting regional leads involved in the decision-making process and fully aligned on the complexity of the project and its potential impact to their functions.

This one decision allowed us to get back on track and guarantee all users’ needs were addressed while ensuring the broader goals and objectives of the organization were being met as well. Having clear communications and more inclusive processes helped them avoid further unexpected starts and stops to the project, but more importantly, ensured greater success for user acceptance post implementation. The client appreciated fme’s expert guidance, ultimately helping them avoid any further costly changes and delays.

 fme’s 8 communication tips for a successful project

  1. At the start of the project, develop a communication plan that maps to the overall project plan and incorporates triggers on when and how to communicate with stakeholders.
  2. Reach understanding, agreement or consensus about pivotal decisions that could impact processes, schedule or stakeholders’ day-to-day job.
  3. Manage stakeholder and project team expectations. A key part of communications is understanding the requirements and expectations of stakeholders so they’re “on board” with the changes that need to happen.
  4. Ensure there is a smooth delegation or handoff of tasks by documenting roles, responsibilities and accountability.
  5. Identify potential project risks and the communication channels and escalation required to minimize those risks.
  6. Develop effective methods to report project progress, looking for opportunities to communicate in person or via regular virtual meetings so there is regular and ongoing communication about the project.
  7. Track progress and let all stakeholders know where the project stands, particularly important as project deliverables or milestones shift.
  8. Create communication channels to quickly share changes with team members as they arise. For example > SharePoint is one of many tools to store weekly status reports as well as meeting minutes and action items.

When good and ongoing communication is built into a project, problems can quickly be addressed and the stress of failure can be alleviated.

Veeva R&D Summit Puts Focus on Innovation and Best Practices

Veeva R&D Summit Puts Focus on Innovation and Best Practices

As a Veeva Migration Services partner, fme was a key sponsor of the summit and we were excited to be part of this growing industry event. During both days of the summit, sessions were separated into tracks: clinical operations, clinical data management, quality and manufacturing, regulatory, the Vault platform and innovation theatres. A total of approximately 400 life sciences companies attended and 61 spoke at the summit.

One of the newer Veeva Vault initiatives is Vault RIM and Veeva has been proactive at making product enhancements based on customer feedback. A key part of moving to RIM is data migration, which is often a complex and time-consuming process. Ultimately, the time spent on the migration is worth the effort since a centralized RIM capability, such as Veeva RIM, is a game-changer for companies.

Moving to a shared data model

A common challenge for many companies is managing product changes, or variations, after receiving approvals, because information is typically not in one place. Veeva and fme client Vertex spoke at the summit about the benefits of having a shared data model within a unified RIM platform. Not only was there a business benefit to this approach but it also helped to align with their objectives of meeting their commitments to patients. Pharma giant GlaxoSmithKline also spoke at the regulatory session about their journey toward unifying regulatory processes and how Vault RIM is helping them to integrate teams in different countries. The ability to simplify deployment and streamline implementation will also be key to ensuring pharmaceutical companies meet their RIM objectives.

Clinical Data Management

Another key track was clinical data management, with a session focused on building and running complex trials using advances in monitoring, cleaning and reporting data. Integral to this is the migration and management of safety data. As companies begin their transition to a more integrated approach to clinical data, they will need to consider their safety data migration fully and carefully.

It was also great to recognize and celebrate Veeva Heroes, which honors six industry pioneers who over the year have gone above and beyond to help move the industry forward. These innovators have pushed boundaries and navigated change at their company to improve processes and deliver outcomes. This year’s innovators included: Jennifer Trundle, Gilead Sciences; Joe Brenner, Johnson & Johnson; Lisa Little-Tranter, Lilly; Michelle Harrison, Vertex Pharmaceuticals; Sandra Freeman, Johnson & Johnson; and Shelly Plapp, Melinta Therapeutics, Inc. Congratulations to everyone.

The Veeva Vault Summit continues to grow and attract increasingly large numbers of life sciences companies that are eager to learn more about areas integral to their business. In fact, the summit has become so large that during this year’s keynote speech organizers had to use an overflow room to accommodate the audience. Next year’s session, which will be held in Boston, will undoubtedly take these large audiences into account.

In addition to joining the 2020 Veeva R&D Summits in both the US and Europe in our capacity as a partner, fme is also planning to sponsor the Medical Device & Diagnostics Summit to be held in Minneapolis in June 2020. Hope to see you there!