Facility Implements FileTrail for Audit-Readiness
Background
Manufacturing and testing records provide the bedrock of evidence that pharmaceutical companies have followed GMP. The ability to track and quickly retrieve documentation as needed to investigate trends, issues and complaints — and complete regulatory audits — is critical over the lifecycle of a product. This organization’s Midwest facility had been using a custom-built database for its Record Center over a period of 15 years. Over time, it had become apparent that the aging system was unable to scale to support the amount of data that the site was processing on a daily basis. To address this, the Quality Systems team had added ancillary tools — including spreadsheets, Access databases, and other forms — to supplement the primary database.“The other issue was that this was a site-specific system, and we were relying heavily on individuals who had historical knowledge of how it worked. We decided to look for a new system that could be supported at the global level by IT support — particularly as our company as a whole is working toward more standardization of systems.”
A Manual Process
On average, the Midwest Record Center receives 2,500 documents each month — batch records, Certificates of Analysis, logbooks, notebooks, calibration documentation, validation documents for equipment and more — plus one-off items that arrive in binders. Under the previous system, information about each docu-ment needed to be entered manually by staff at least three times into three different systems — including multiple spreadsheets in addition to the primary database — before getting filed away onto a shelf within the Record Center. Retrieving an item from the Record Center required an initial step of trying to find where it was likely to have been shelved, confirming its location, and then updating forms and spread-sheets to check the item out. “We were spending a lot of time duplicating efforts. It was a completely manual process,” says the Project Delivery Manager.About FileTrail Corporate Records Management Solution
In today’s digital age, efficient and compliant record-keeping is more critical than ever. Organizations across industries face increasing complexities in managing, storing, and accessing vast volumes of information while maintaining regulatory compliance. Recognizing this challenge, FileTrail offers an innovative, robust, and intuitive Corporate Records Management Solution tailored to streamline records management and enforce information governance practices.
FileTrail’s Records Management Solution leads the way in transforming how businesses manage their records and information assets. With an emphasis on visibility, control, and compliance, our solution helps businesses effectively oversee their growing repositories of both physical and electronic records.
Our unique approach to records management ensures easy integration with existing systems, resulting in a seamless transition and ongoing operation. Whether you’re dealing with legal documents, financial records, or internal communications, FileTrail’s platform offers a centralized, secure, and searchable environment, effectively eliminating the hassle of manual tracking and retrieval.
Embracing the principles of information governance, FileTrail provides comprehensive lifecycle management of your documents, from creation through retention to final disposition. This includes features like automated retention schedules and legal holds to enforce regulatory compliance, safeguard sensitive data, and mitigate risks associated with information management.
FileTrail’s Corporate Records Management Solution employs advanced analytics, delivering insightful reports to enhance decision-making and ensure audit readiness. Moreover, it offers an added layer of security with access controls and encryption, protecting your data from unauthorized access and breaches.
With FileTrail, we empower you with state-of-the-art records management software to promote transparency, compliance, and efficiency in your information governance practices. We believe in providing a solution that is not just about managing records but transforming how you interact with your information assets.
For a more organized, compliant, and secure approach to records management and information governance, trust FileTrail – the trailblazer in comprehensive, user-friendly, and integrated records management solutions.
