Getting to Market Faster: How to Leverage Quality Consultants With an eQMS or EBR

Finding the right balance between internal resources, external consulting support, and new technology can be extremely challenging. In today’s climate it seems we need to watch every dollar we spend and be personally accountable for every new headcount request, leading us to ask ourselves:

• Do I hire more personnel to review corrective actions/preventive actions (CAPAs) or do I automate my CAPA system?
• Do I review all the contract manufacturing records or do I trust the contract manufacturing organization (CMO) to abide by our quality agreement and their internal procedures?
• How do I reduce our document review cycle even though I know our quality staff is at capacity?

These are the types of questions that quality and manufacturing personnel must face every day. There is a beautiful simplicity in finding the correct balance of internal resources, external support, and automated tools, but the path requires us to look closely at our own operational goals and constraints.

Don’t Be Afraid to Automate Processes

Automating critical systems like a quality management system (QMS) or manufacturing batch records (MBR/BMR) can improve manufacturing accuracy and efficiency and reduce costs. Automated systems like an electronic quality management system (eQMS) or an electronic batch record (EBR) system can ensure that processes are carried out in the same way every time, reducing the risk of human error. By reducing the need for people to intervene, automation can lower labor costs, minimize waste, and reduce errors related to good documentation practice (GDP) activities. When using automated systems with data collection tools, companies have access to large amounts of real-time data. This allows quality and manufacturing personnel to quickly improve their processes and products.

If a company is expecting growth and an increase in manufacturing capacity, an automated system (like an eQMS or EBR) is ideal for scaling quickly and maintaining a large amount of information. Setting up a secured tool with structured data facilitates easy growth because the structure is already established and the processes are pre-defined.

Take a look at some of the benefits associated with general eQMS and EBR software solutions. See if these benefits may outweigh the costs associated with the purchase and implementation of these tools.

Electronic Quality Management System (eQMS)

• Centralizes quality management.
• A single platform for managing all quality processes, documents, and data.
• Makes maintaining and retrieving information easier compared to paper systems.
• Provides traceability of all quality-related activities and documents.
• Fosters collaboration across departments by providing a common platform.

Electronic Batch Record (EBR)

• Centralizes batch record management (including review, release, and storage).
• Provides real time data.
• Integrates with other enterprise systems such as manufacturing execution systems (MES), enterprise resource planning (ERP) systems, and laboratory information management systems (LIMS).
• Facilitates data flow across the organization.
• Reduces human errors and manual interventions.

Under both an eQMS and MES, organizations can collect and analyze quality data in real time. This data-driven approach supports better decision-making and continuous improvement initiatives. Manufacturing and quality personnel can make data driven decisions and reduce product hold times.

Use Consulting Resources to Help With Implementation and Routine Tasks

There is an old adage about being penny wise and pound foolish, meaning that while you are watching your pennies you may be wasting pounds (British pound sterling) on the other end.

Companies are often reluctant to hire consultants to assist with implementation and execution of eQMS and EBR systems, but hiring quality consultants can be a huge cost savings and lead to a more standardized implementation of the processes. Experienced quality consultants can execute tasks quickly and help avoid costly mistakes.

When implementing an EBR, evaluate consulting resources to:

• Assist with implementation and validation.
• Review electronic batch records.
• Assist with product release.
• Review process parameters, quality attributes, and specifications.*

*It is helpful to get a fresh perspective on your process (i.e., current specifications, process parameters, validates ranges, and quality attributes) before automating systems like an eQMS or EBR that will function independently.

When implementing an eQMS solution, evaluate consulting resources to:

• Assist with implementation and validation.
• Upload historical records and data.
• Conduct an ongoing review of quality data and trends.
• Review quality events such as CAPAs, out of specifications (OOS), nonconformances, and deviations.
• Perform independent quality audits.
• Review supplier (or CMO) data and nonconformances.

Outsource Tasks to Qualified Individuals Who Understand Your Process

It is important to supplement your team with qualified individuals who share your enthusiasm for streamlining your process. The quality consultant should understand your product and your objectives, such as process optimization, risk minimization, cost reduction, reducing production time, improving the quality of commercial products, etc.). For example, if your goal for implementing an EBR is to reduce production errors, these should be documented, quantified, and clearly communicated. Above all, make sure the people you hire fit the communication style of your organization and the CMO they may be interacting with.

Free Up Employees to Attack the “Big Ideas”

By hiring outside consultants to assist with the eQMS/EBR implementation and ongoing manufacturing and quality support, you can free up full-time manufacturing and quality staff to address the larger problems of the organization. What would your company look like if you redirected existing employees to:

• Addressing known vulnerabilities.
• Looking for strategic cost savings in existing processes or products.
• Focusing on continuous improvement.
• Brainstorming what your next-gen product may look like.
• Preparing for upcoming inspections/audits/customer visits.
• Collaborating on new product filings to shorten your time to market.

Bringing in consultant resources to implement or perform daily tasks in the eQMS or EBR can free up existing employees to focus on your organization’s “Big Ideas.”.

Don’t Lose Sight of Purpose and Accountability

When automating processes and leveraging consultants, don’t lose sight of the big picture. Maintain focus on product quality and overall accountability of products and services. Remember, even though you may use a CMO you can't outsource your manufacturing and quality responsibilities. Leveraging consultants to assist with batch record review, quality events, and supplier quality does not change the legal requirements put on the manufacturer or license holder. Companies can’t implement an eQMS or EBR to reduce their quality and regulatory obligations.

Don’t get bogged down in being the first to implement a new software or tool. Find the right tool that fits your organizational needs, expected growth, and technical IQ. Remember the main purpose for implementing the new tool and stick to a rigid implementation plan.

Putting It All Together

When balancing 1) internal resources, 2) consulting resources, and 3) automated tools, evaluate your company’s needs in terms of risk and resources. Would adding consulting resources to perform routine tasks free up employees to move the company forward or dramatically improve quality? Would spending money on automation allow your company to obtain the consistency, efficiency, and data that it is looking for?

Bringing in consulting resources can enable your organization to implement automated tools like eQMS and EBR quickly and with more standardization. Consider using consultants to review existing requirements, parameters, and systems before putting this information into an automated system. Using low-cost providers to perform daily quality activities keeps your employees in a position to review products and processes across the organization and frees them up to attack the “Big Ideas.”