Part11 csv case final
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RCM Technologies is a premier provider of business and technology solutions, uniquely designed to enhance customers' operational performance through advanced IT and engineering services. For over 35 years, RCM has innovatively led the design, development, and delivery of these solutions to commercial and government sectors across North America and globally.
Part11 csv case final
- 1. RCM Technologies (NASDAQ: RCMT) is a premier provider of business and technology solutions. These solutions are uniquely designed to enhance and maximize the operational performance of customers by adapting and deploying advanced information technology and engineering services. For over 35 years RCM has been an innovative leader in the design, development and delivery of these solutions to commercial and government sectors. With offices throughout North America and the capacity to delivery globally, RCM offers its customers solutions on a national and international scale. Background On March 6, 2002, the FDA announced that a consent decree of permanent injunction had been filed against one of the nation’s top pharmaceutical corporations for failing to comply with numerous FDA regulations. In addition to a $500 million fine, the consent decree halted the company’s production of 73 human and veterinary products and mandated the recall of two of the company’s core medications. In response to the consent decree, the company needed to assess the compliant state of its computerized systems, Excel spreadsheets and databases used to support stand-alone laboratory systems. All assessment finding needed to be documented and appropriately addressed. The client requested RCM to provide both managerial oversight and the delivery personnel to complete required activities. Goals Assessment phase Assess, document and communicate the current compliance state of 50+ stand- alone laboratory systems and supporting spreadsheets and databases. Identify compliance gaps and remediation action. Remediation phase Ensure full 21 CFR Part 11 compliance for regulated systems. Based on the assessment findings risk rating, implement required scaled computerized systems validation efforts. Implement and document retirement of 100+ systems. Approach RCM enlisted and managed a highly effective team of 28 Validation and 21 CFR Part 11 technical experts. The team was responsible for: Executing and documenting the regulatory assessment of the systems in scope and identifying the gaps and remediation activities. Defining and implementing a Part 11 compliance strategy. The implemented solutions included system upgrades to later versions and the implementation of a third part “wrapper” system that ensured Part 11 compliance. Generating a full suite of validation documents for 50+ systems. Implementing purely procedural remediation for 15+ systems. Implementing and documenting the retirement of 100+ systems. Documenting and transferring the knowledge needed to support the validated system environment. Benefits RCM met the project compliance, quality, and delivery goals within the allocated aggressive time lines. RCM remediated the client’s Part 11 compliance and validation state and implemented next-generation technology solutions. RCM generated and transferred standards, creating a roadmap for effective and sustainable compliance. RCM generated and transferred to the client standards for effective and sustainable compliance. RCM remains a trusted advisor and partner in effective and compliant ongoing execution to this day. Case Study Consent Decree Remediation Project 21 CFR Part 11 Compliance Computerized Systems Validation RCM’s mission is to be a trusted advisor and partner in execution by providing responsive, high-quality, reliable, technologically advanced, and cost-effective services that enable its customers to meet complex business objectives