How to be regulatory compliant with EAM in the life sciences industry?

The life sciences industry directly impacts the well-being and welfare of living beings. Any error on their part can have a far-reaching impact across diagnostics and treatment for millions around the world.

Hence, to ensure error-free business continuity, the industry must comply with multiple regulations covering records and change management, equipment calibration, facilities management, manufacturing, quality assurance, distribution, etc.

In the United States, the Food and Drug Administration (FDA) agency under the Department of Health and Human Services (HHS) has established multiple guidelines with which pharmaceutical, MedTech, medical original equipment manufacturers (OME), etc. must comply. These guidelines under the Code of Federal Regulations (CFR) cover multiple aspects like product jurisdiction, combination products, enforcement policies, administrative practices, electronic records, current good manufacturing, etc. across categories.

We see two ends of the statement. (1) Life sciences industry directly impacts lives so it needs regulations; and (2) every country, like the US, has firm regulatory measures in place to ensure the same.

So, what is the problem? Let’s break our flow into two parts.

1. Why is regulatory compliance one of the biggest challenges facing the life science industry?
2. How can Enterprise Asset Management (EAM) help the companies comply with all these regulations retroactively and in real-time?

Why is regulatory compliance a challenge for the life science industry?

Most of the successful life science companies are using SAP ERP products in some form or the other and have managed to effectively leverage solutions from companies like Crave InfoTech to run their EAM like clockwork.

However, there are still many companies that find it hard to completely comply with all the established guidelines. Here are some of the challenges that these companies face.

• They operate without a centralized database or system. Their information is stored in disparate databases leading to multiple silos across plants, clinical research facilities, central offices, etc.
• Their documentation and records are, many times, managed manually with a clear delay between data capture and system update. Again, many times, as the process is delayed and manual, this leads to errors.
• Their maintenance is often reactive and not predictive. This means that there’s a long gap between anomaly observation, work order generation, assignment, execution, technical completion, etc.
• The on-field technicians and surveyors, often, don’t have direct access to the master data covering the equipment or asset in question. Even when they do, the data isn’t centrally updated and may be outdated.
• The same problem occurs when there are project, product, or process upgrades. The delay in recording and reporting of the changes usually means that the end result is either erroneous or missed altogether.
• The system isn’t securely encrypted which means that the efficacy of the data and research is compromised.

Even though the CFR guidelines may seem based on the common sense of oversight and regulations, why is it still so hard for companies to comply with the same? There are three main reasons.

1. Lack of pre-emptive risk management Even some of the bigger names in the industry have received 483 citations from the FDA post inspections. The reason is that the manufacturing, maintenance, and distribution of medical devices, essentials, drugs, etc. is a very dynamic endeavor. These companies aren’t always aware of all the new and old regulations governing each equipment, product, or process. Even when they are aware, it’s hard to ensure that these processes are followed at every single instance and at all times. They simply don’t factor in the risk of non-compliance within their business plans as they assume continuity across planned and unplanned factors.
2. Scale of operations and information disbursal These companies mass-produce millions of products across manufacturing plants post a heavily funded research process. The scale of operations and the information entailed is so enormous that it’s hard to bring them under the gamut of a single overarching intelligence system. This results in a delay in downstream or upstream information disbursal. Essentially, multiple violations can occur simply within the time it takes to observe a problem, report it, plan for a fix, and its final execution.
3. Cost of compliance and total digitization The obvious and direct factor is the cost involved in achieving total compliance and digitization within an organization. Companies are naturally averse to committing to the Total Cost of Ownership (TCO) of this ‘upgrade’.

How Crave InfoTech’s EAM can solve all compliance problems for life sciences

Crave InfoTech has, in its fast-growing years, gained the confidence of the life science industry as it built its pre-packaged products as standalone solutions or built over SAP systems. The entire structuring and ease of use within these products are based on collaborative inputs from top industry players across countries. So essentially, it’s a solution-specific and deployment-ready EAM product for all life science companies.

Let’s see how Crave InfoTech’s solution answers the problems stated above.

1. Bring down TCO by up to 80% Crave’s products bring down the total cost of deployment and long-term cost of ownership for the system by a significant margin. As the products are built on the collaborative intelligence gained from the industry, they come with a flat learning curve. This means that the users derive much more value (including higher wrench time and lower downtime) from them as compared to a static legacy system. The products have an inherent market-readiness which means that the client company can deploy them 70-80% faster than other systems. What’s more, the products continually improve leveraging their internal artificial intelligence. This makes the client company totally future-proof. At no point, would they feel their competition outpacing them? This also directly cuts down the cost of future upgrades.
2. Real-time on-site data capture and central sync One of the key reasons for violations is manual on-location data capture and mismanaged records. Crave InfoTech overcomes these issues by enabling the ability to in-scan or directly feed the job details in the system. Crave’s total enterprise mobility enables the on-location technician to simply key-in or scan the target instrument, product, or machine’s code into the system. They can then access the real-time updated master data covering the job, as they follow a streamlined workflow to satisfactorily complete the said job. All records, suggestions, changes are recorded directly (without error) into the EAM system and processed through approvals or regulatory sign-offs.
3. Predictive EAM for total risk management Crave InfoTech helps client companies to move from reactive asset management to predictive EAM that helps them conduct detailed analytics and risk profiling to get ahead of all possible eventualities. Crave’s products also help digitize and automate all processes to finally bring all operations under a single synchronized and user-friendly system. With Crave, the client company can ensure that they adhere to current and evolving regulations including high-end system privacy. This means that all processes would follow the latest guidelines, just as they are issued. Also, all workflows would ensure that no ‘step’ is ever missed while conducting key maintenance, quality assurance, or calibration jobs. All data is even verified with e-signs and proper documentation.

All in all, at any point the client company is totally audit or inspection ready. Moreover, with effective Enterprise Asset Management, the company infuses efficiency within their operations and boosts their asset performance with better-managed lifecycles. It’s a win-win for all regulators, companies, and the people.

Just reach out to us and we’ll guide your company to become compliance-positive in no time.