Medical device manufacturers face constant changes coming from both internal and external sources. Change is inherent to any production environment, as well as any quality-driven process because they are dynamic by nature. The key to safe and effective production is change control. The key to continuous improvement is leveraging it — all while managing the risks inherent with disruption and maintaining the safety and efficacy of the product.
Internal feedback from audits, executives, employees, and customers can all drive necessary change. External pressures can stem from changes in standards and regulations set by regulatory bodies, such as the European Union Medical Device Regulation (EUMDR), in addition to shifting market demands and limitations. Changes are further influenced by developing technology. All of this makes for a dynamic mix of change drivers, one that may seem unmanageable and leave manufacturers scrambling. However, with an efficient change control system, OEMs can manage change effectively by focusing on areas that have the greatest impact on the organization.
Common Challenges with Change Control
Change control is integral to, if not synonymous with, quality management. It affects all the processes, products, and largely the records that comprise life sciences as a regulated industry. Changes may involve modifications to equipment, materials, facilities, designs, packaging and labeling, computer systems, and training procedures. There is no reason that change control should cause significant delays in production, but it does. When trying to implement postmarket changes or execute a corrective action/preventive action (CAPA), delays and difficulties can be compounded further. 1
Because of the direct link between quality and control, regulations are in place to ensure that changes don’t put the consumer at risk. It’s critical that manufacturers of regulated products adhere to strict change control guidelines and accurately document changes. Because of this, there are several pain points surrounding change control. These include planning changes to align with evolving regulations, reviewing changes prior to implementation, having qualified personnel approve changes, and showing justifications for and evidence of changes.
Inspections commonly show a high number of deficiencies in design control, written procedures for production, and written procedures for processes. They also reveal deficiencies in the following areas: inadequate planning, review by key stakeholders, follow-up efforts, corrective actions, incomplete documentation, insufficient evidence and explanations, and lack of training and communication.2 The common complaint here goes back to insufficient records. Everything must be documented properly, further referenced, and followed strictly. When there is an inspection, producing the required documentation can be very difficult in paper-based or hybrid production environments.
Streamlining Change Control
With paper-based processes and production records, change control guidelines can easily go unmet without enforceable workflows and automatic alerts to indicate an oversight. In no time, well-meaning innovators can unknowingly create an out-of-control production environment. Digital controls, on the other hand, allow manufacturers and quality personnel to efficiently initiate, review, plan, and monitor changes with adequate documentation, and these controls also signal and secure communications. OEMs can quickly see what is happening, what has been done, and what needs to be done. The result is a system that is in a constant state of audit-readiness. With more advanced digital systems, OEMs can also ensure that employees are current with training on the latest changes.
Change Control: Data
One of the biggest disadvantages of paper-based processes is the challenge of recruiting and analyzing large amounts of data for continuous improvement. With a digital, integrated quality management system (QMS), OEMs can easily collect and analyze data, using it to review how CAPA and other areas of the quality management system, such as training or design documents, work together. Looking at trends revealed through data allows for timely and proactive decisions. Good data leads to good decisions that improve the safety, efficacy, and time to market of products. The bottom line is that integrated processes and advanced analytics lead to enhanced efficiency — and these features are readily available in a purpose-built digital quality solution.
Change Control: Documentation
At the very core of change control is documentation. Change control essentially becomes a documentation management issue. Documentation is used to establish and update compliant procedures, develop compliant products, and ultimately show compliance to regulators. According to the U.S. Food and Drug Administration (FDA), an OEMs call to action is to “write useful and effective documents that provide direction and evidence of compliance and quality.”3 Using electronic records in the place of paper documents allows the company to easily adapt to changes and answer the FDA’s call to action in the following ways:
Follow the company’s own procedures for document and record keeping.
Enforce document controls, including review, approval, and versioning.
Leverage document templates to complete larger records.
Access documents remotely and utilize electronic signatures.
Getting to the heart of the matter, good documentation, in the form of electronic records, makes it easier for the company to share information, collect data, and analyze it for best practice when implementing changes.
Regulatory Changes on the Horizon
In addition to the FDA, there are several global entities focused on standardization and good manufacturing practices affecting life sciences. These include the International Organization for Standardization (ISO), International Council for Harmonization (IHC), PIC/S, and GAMP. Official regulatory requirements and guidelines for medical device manufacturers are outlined in sections 21 CFR 820.30 (design controls), 820.40 (document controls), 820.70 (product and process controls) of the U.S. federal code, as well as ISO 13485:2016. The FDA’s Title 21 CFR Part 11 outlines compliance requirements for electronic records, including signatures.
It is critical to be up to date on regulations that directly impact the organization. It is further critical to be aware when regulations change. So, what changes can be expected? This can be answered by asking some additional questions.
How will harmonizing with ISO 13485 impact 21 CFR Part 820 Quality System Regulations and ultimately an OEM’s quality management system? Industry will know for sure when the FDA begins providing training on the final Quality Management System Regulation (QMSR) rule once it is implemented. Currently, sections with differences include Document Controls (subpart D), Labeling and Packaging Control (subpart K), Records (subpart M), and Servicing (subpart N).4 Medical device OEMs should be familiar with (if not certified to) ISO 13485 and be prepared to revise workflows, documents (including SOPs), and training. The FDA announced that the most notable difference between the two is the risk management requirements integrated throughout ISO 13485.5 A digital solution is crucial here — one that offers built-in risk management tools allowing the OEM to identify and offset risk to avoid nonconformances and execute CAPAs.
What is the FDA’s computer software assurance (CSA) guidance all about? The FDA recognizes that there are onerous and confusing regulations surrounding computer system validation. These have impeded the adoption of automation and digital technologies that can ultimately yield the highest and most timely benefits for consumers. Compliance has displaced quality in this instance. The FDA’s aim is to grant flexibility to organizations to ensure software quality by targeting higher-level processes as well as particular features that directly impact product safety and efficacy.6 This puts into relief the FDA’s emphasis on digital transformation and automation to keep pace with the technological advantages of Industry 4.0. What it means for OEMs is that they need to find a seasoned software vendor — one that can leverage their experience to identify and address these highest areas of concern. This enables the company to be a step ahead as soon as the solution is implemented.
The Only Constant Is Change
As one modern movie character stated, “Prepare to be surprised.” Change is coming and always will. Fortunately, with a digital solution, OEMs can incorporate necessary changes while navigating inherent risks more efficiently than by using paper-based documents. A digital solution can help the company properly focus efforts on areas that present the organization with the most risk and ensure ongoing compliance. Consequently, the company will be able to continue operations as it evolves systematically and organizationally. Once the company finds this digital sweet spot — the perfect balance between change and risk — change no longer delays time to market but can hopefully expedite it.
- "How to Address the Top 6 Pains in DHF Management," Matt Lowe, MasterControl, Inc..
- "Inspectional Observation FY 2021 data set," FDA web site Inspection Observations page, Nov. 24, 2020.
- CDRH Learn: Documents, Change Control, and Records,” Joseph Tartal, Division of Industry and Consumer Education, U.S. FDA, accessed August 2022.
- "Medical Devices; Quality System Regulation Amendments," U.S. FDA, Feb. 23, 2022.
- "Proposed Rule: Quality System Regulation Amendments – FAQ," U.S. FDA, current as of 01/22/2022.
- "CSA vs CSV: FDA’s New Guidance for Software Assurance," Mohamed Benkirane, Critical Manufacturing, Feb 8, 2021.