Life Science, Pharmaceutical

Life Science & Pharmaceutical

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Learn how Interfacing can help make your GxP digital quality program better

Digital Quality Management Software (QMS) for Medical Technology

Every aspect of the medical technology process must be controlled and monitored as per ISO 13845 and US FDA QSR requirements for medical device organizations. In order to ensure the integrity of the enterprise and to maintain quality assurance, the implementation of additional standards such as ISO 9000 must be pursued. This means installing efficiently designed processes throughout the operation from product development, to supply chain and shipping. By adopting a strong, process-centric culture, your company can smoothly transition from chaotic and ad hoc management systems to a smooth running operation that will increase profits.

A Solution Designed for the needs of the

Medical Technology Industry

Interfacing’s process optimization & automation, SOP documentation digitalization and proactive regulatory vigilance solution, the Enterprise Process Center© Suite has brought about significant time savings with accelerated approval & validation, improved visibility and operational improvements for customers including the following:

End-to-end alignment

The EPC allows life science organizations to easily align departments, regulations, procedures, controls, within a single repository to enable quick and standardized continuous improvements. Our technology allows information fragmenting to build reusable data fragments.

Accelerated approvals and validation

Interfacing QMS solution delivers sustained time saving by reduced training, updating and re-training time. The integrated approval, review and endorsement workflow also helps streamline the validation of new version of the standard operating procedures (SOPs) through fragmented content review and approval cycles to aid decision-making.

Digital Signature and Multi-Factor Authentication

EPC meets the very stringent requirements associated with compliance for FSA QSR, ISO 13845, GxP programs, and all SOPs and processes are parsed and documented, providing the audit trails meeting compliance with 21 CFR Part 11 Electronic Record and Electronic Signature (ERES) and a host of other regulatory requirements through RSA encryption, vault key story, and multi-factor authentication (MFA)

Improved Speed and Agility

Interfacing’s Enterprise Process Center© Suite is fully mobile and digital, providing life science organization with the flexibility of quality documentation readily visible through a variety of means including phone, tablets, graphical and textual to boost employee agility and self-training.

Multi-language support

Interfacing’s Enterprise Process Center© Suite provides insightful ways to manage global content, whether by automated translation suggestions for all fragments of content, or the ability to collect variance for SOPs by country, region or product-type

Good Pharmaceutical Manufacturing Practices

We understand that the requirements placed on pharmaceutical companies in terms of compliance are very high and that GxP is an essential part of that program. By using our solutions, your company gains the accountability and consistency that will give you a cutting edge over your competition. Our tools ensure full visibility from end-to-end, all the way from the creation and amendment of a regulation to the approval and revision of the content through to the update and retraining of employees for standard operating procedures (SOPs). We see the full lifecycle management as moving parts of a complete ecosystem and that’s why are unique approach that combines regulatory requirements, documents, processes, work instructions, and governance.

GxP Compliance

Our approach can help with all regulations and compliances related to pharma production and medical devices (GxP, CFR, GCP, GLP, GMP, HIPAA, ISO9001, medical devices regulations, SOX, BITS, CSA, FDA, FedRAMP, FIPS, FISMA, MHRA, NISP DoD, PCI DSS, SOC 2, U.S. SEC 17a-4 among others).

Manage Content

Manage the individual pieces of information, assign owners, and ensure governance through approval cycles, and change requests.

Digital Signature

We fully support digital signature to ensure that the audit trail of all content is secure, time-stamped, with accurate and complete copies of records available for inspection throughout the retention period.

Ensure Transparency

Full visibility to understand where records are used and their applicability. You can also maintain digital content with clear accountability, including roles and responsibilities.

Conduct Impact Analysis

Analyze your records for downstream impacts, and analyze the potential impacts on policies, SOPs, business units and related records.

Digital SOPs

Generate complete customizable output of processes and related records such as regulations in a ready-to-print and exportable Word format. You no longer need to manage SOP on paper! The digital SOP is in-sync all the time.

Approval and Governance Workflow

Integrated and embedded approval workflows to ensure strict control over the change of your records, including validation of changes, evaluation of impacts and highlighting changes.

Encourage Collaboration

By uniting goals and creating a common framework for your teams, they will be able to cooperate strategically, create change requests, and assign tasks to implementers.

Commitment to Compliance

As part of our ongoing commitment to compliance and ensuring that our clients meet their regulatory requirements, we are always on the lookout for ways to help our clients attain and maintain full compliance.

ISO 27001 Certification

Interfacing is ISO 27001 certified, demonstrating our commitment to top-tier information security and client data protection. We provide a secure, compliant environment clients can trust.

Partnership with AWS

We're partnering with Amazon Web Services (AWS) for cloud hosting due to their proven compliance standards. AWS’s global data centers meet SOC 1 Type II and ISO 27001. For details on their compliance with ISO 18345, FDA QSR, and GxP, see their compliance program.

Request Free Demo

Document, analyze, improve, digitize and monitor your business processes, risks, regulatory requirements and performance indicators within Interfacing’s Digital Twin integrated management system the Enterprise Process Center®!