Real-time Audit Readiness
Whether you're in research or manufacturing, working in a regulated environment requires consistency and precision. Processes need to be in place, facilities need to be cared for, and equipment must be properly maintained and calibrated. Asset managers can expect routine examinations by both external agencies and internal teams to ensure a constant state of compliance.
Audit Trail
There are two groups that our customers face most commonly:
1. FDA: US Gov't Agency covering any manufacturers or labs that produce products or perform research to GxP standards in industries like pharmaceuticals, therapeutics, supplements, and medical devices. Their purpose is to help protect consumers and businesses from unsafe products.
Types of audits:
- Pre-approval inspection after a company applies to the FDA to market a new product.
- Routine inspection of a regulated facility
- "For-cause" inspection to investigate a specific problem that has come to FDA's attention
2. ISO: ISO (International Organization for Standardization) is a worldwide non-governmental organization that comprises standards bodies from more than 160 countries.
Some common accreditations we see in our industry are:
- ISO 9001: Organizations of any kind, from pharmaceutical to automotive
- ISO 17025: Calibration and testing laboratories only
ISO audits to review your quality management system in pain-staking detail, requiring stringent document control, data integrity, and compliance strategies to secure or maintain accreditation.
Where these organizations differ: FDA is a government enforcement agency and is predominantly reactive versus proactive. Inversely, ISO auditors are generally invited to audit, as accreditation acts as a "badge of honor" from trust and quality perspective in the marketplace.
The Validation Process
Validation is the set of procedures through which you establish documented evidence that a facility, process, or product provides consistency in data or product quality. The key purpose of validation is to ensure repeatability and minimize risk.
Here are some of the main components to the validation process:
- IQ (Installation Qualification): To certify the full set of installation activities for each software component, including version, date, listing of components.
- OQ (Operational Qualification): To perform QA and testing on an independent QA test platform with the identical configuration and install procedures that are used for the platform’s testing and development standards.
- PQ (Performance Qualification): To simulate different use cases and environments with the goal of reducing customer issues. Executing PQ validation tests is essential in an environment where evolving regulations necessitate frequent code changes.
Validation is required in many FDA and ISO regulated scenarios and plays a vital role in the risk management process.
Equipment Management Centralization
Some of the most sophisticated organizations across the globe are still using excel or manual processes to track and manage asset inventory. Not only does this require constant duplication of effort as you try to juggle multiple software solutions and manage external service vendors, but it also presents some enormous risks.
It leaves Major room for human error, e.g., entering the wrong due date when updating your Excel sheet, forgetting to upload a certificate into your shared drive, miscalculations while taking readings during an internal service order.
If you're lucky, you'll already have asset management software of some kind in place. Quite often though, these systems are antiquated, glorified Excel sheets that hold you back with the difficulties they present, including:
- A lack of automation and unintuitive UI makes using the system time-consuming and frustrating.
- Classic validation protocols that require revalidation of the entire system with each release.
- A lack of cloud infrastructure requires IT resources and servers that can fail right when you need them.
In the case of a homegrown system, you're at the whim of your developer whether, it comes to bug fixes, support, or product improvement.
So how does Qualer help simplify the audit preparation process? In a general sense, the software helps by ensuring that there are no fractures in your equipment compliance strategies and leverages automation to reduce error potential. Qualer itself comes validated out of the box, meaning that your software solution performs exactly as it is designed to with absolute precision and consistency. Being cloud-based also means that we take the load off of you when it comes to server and IT resources with a sleek, modern UI that makes it easier to use and onboard new employees.
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