Updated on April 13, 2020 by Rick Emlet
This concept is at the heart of IT security. Getting your internal and external teams to work together in unison for seamless compliance is a challenge we can help you overcome. Virtually everything related to data security – IQ validation, change management, disaster recovery planning…is connected to this central issue.
It seems simple. We all have to work together to achieve and maintain compliance. But, putting this team effort concept into action isn’t so easy. How can we make this a reality for our biopharma or life sciences customers? What responsibilities need to be covered? Who is in charge of them? How can we ensure our team continues to meet compliance controls and processes? A lot of questions start to pop up when it’s time to put the wheel of compliance in motion.
The Importance of Process Validation
The FDA’ “Guideline on General Principles of Process Validation” established the first set of regulations for the biopharmaceutical industry over 30 years ago. It outlined the need for manufacturing companies to thoroughly validate processes. This serves to verify that:
- Each piece of equipment utilized reliably operates as required, and
- Each process reliably makes products that meet the established quality standards.
Since the publication of this initial guideline, the same two-pronged goal has been adopted around the world as the standard for process validation. To ensure consistent quality and safety in manufacturing, companies were required to start providing evidence of equipment qualification. This meant documenting the design and installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) to show that they can repeatably meet process requirements.
Process validation has evolved since that landmark FDA guideline was established. Now, rather than a one-time process, it is an essential, ongoing effort. As long as the engine of a business is running, the wheels comprised of the compliance team and activities keep turning. Even regulatory bodies expect that manufacturers now fuel continual verification processes. They must show a full understanding of the regulations and check that processes and products consistently meet specifications in order to get become and remain compliant with applicable regulations.
There is no ‘one-size fits all’ solution for compliance either. Validation protocols must be developed to respond to the unique set of potential risks that an individual organization faces. In fact, this evolution can be seen in “Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach” released by the FDA in 2004. Now, as we begin this new decade, it’s clear that a strong risk management program is necessary to successfully carry out process validation. This requires ongoing risk assessment, control, management and review.
Compliance Is the Hub
Especially in the biopharma field, validation and compliance are broad-reaching and critically important. When done right, compliance involves a lot of people across the organization, and even third-party vendors. The spokes link software development teams, IT departments, sales personnel, HR and legal , as well as C-suite members. Simultaneously, the spokes connect activities ranging from vetting new hires, handling data during the sales process, writing contracts for vendors, manufacturing, and oversight, to name a few.
It’s impossible for one staff member, or even a single department, to manage all of the personnel and processes related to compliance. This is why compliance demands a systematic, comprehensive approach and – ultimately – a team effort to be successful.
Sharing the Responsibility in Compliance Procedures
Each organization is ultimately responsible for maintaining compliance. They are in the driver’s seat. But they must also rely on and incorporate a lot of other moving parts in the process. And each component – internal and external – must be knowledgeable about compliance requirements and active in the related processes. All the spokes must be coordinated around the central hub of compliance in order to be successful.
Businesses in the pharmaceutical and biotech industries increasingly rely on external components, such as vendors. Yet, regulations such as PCI, HIPAA, HITECH, and those set by the FDA, are continuing to tighten regulations on third-party vendors. As a result, vendors must fully understand the demands of regulations and actively work with your company to support compliance goals.
Similarly, MSPs and CSPs may play a critical role in compliance activities. Whether they are charged with building and maintaining a secure network, or managing a vulnerability program, service providers must uphold your company’s security policies. With managed cloud services, all of this is still possible provided you select the right vendor. The CSP and your company must seamlessly work together and share the responsibility. Here are the shared responsibility frameworks set by the top three cloud providers:
- Microsoft Azure: Shared Responsibilities for Cloud Computing
- Amazon Web Services: Shared Responsibility Model
- Google Cloud Platform: Customer Responsibility Matrix
Read more about How Cloud Validation Simplifies Compliance for Life Sciences Industry.
Building a Solid Compliance Team
So, who do you need on your compliance team? The answer depends on your organization’s structure, and regulatory obligations. But, generally, the spokes will link these internal and external figures:
- Compliance officer,
- IT director,
- C-level executive,
- Software development personnel,
- Datacenter representative,
- MSP/CSP,
- Vendors with security or compliance responsibilities,
- Assessment firm and external consultant,
- Legal department representative, and,
- HR department representative.
Each member should have his/her own primary tasks, yet they share the overarching responsibility of risk management. Once you have your team and strategy in place, it’s time to put the wheels in gear. Ideally, the spokes of this team will move in sync, collaborating so that compliance activities become second nature and operations run smoothly.
Your Cloud Services Partner Matters – Outer Edge
Outer Edge is completely engaged in the compliance processes of our clients. We assist and consult with respect to IT related projects, provide change management documentation and IQ validation evidence. We even work with project teams that are implementing a new application to design and verify the infrastructure specifications required. Plus, we’re available seven days a week, 365 days a year to provide support when you need it.
Our goal is to first understand your business needs and requirements. Then, we can help you design, manage and prioritize your IT security and compliance needs. Let’s start the process; call 844-OET-EDGE or send an e-mail to set up an appointment with one of our technical experts today.
