At MS Remedies Inc. we provide services to healthcare industry to comply with the Computer System Validation (CSV) requirement that is issued from the FDA. The Code of Federal Regulation (CFR) mandates that pharmaceutical and biopharmaceutical companies to establish Computer System Validation (CSV) and have the specific controls and procedures in place to consistently produce results that meet its predetermined specification and quality attributes.
MS Remedies Inc. brings a thorough understanding of the requirements established by FDA and other regulatory agencies around the world, and a practical risk-based approach to CSV which helps healthcare industry to meet global regulatory requirements, eliminating the GxP compliance risk. Our highly qualified and experienced consultants have excellent experience and have the right capabilities and tools to tackle ERP, manufacturing, laboratory, and clinical systems.
This services is offered for any GxP sensitive computer system implementation, development, upgrade which include: IQ, OQ, PQ with all other validation deliverables as per GAMP standards. The service also include GxP control mitigation and 21 CFR Part 11 analysis. MS Remedies Inc. have standard CSV protocol templates, processes implementation strategy and standard operation procedures (SOPs), tools, reusable assets like User Requirements Specifications (URSs), Functional Requirements Specifications (FRSs), etc. which helps reduce the CSV timelines.
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations (CFR) that establishes the United States Food and Drug Administration (US FDA) regulations on electronic records and electronic signatures (ERES). Title 21 CFR Part 11 is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)). At MS Remedies Inc. we perform Title 21 CFR Part 11 analysis and remediation as a part of CSV end to end validation services or separately if Title 21 CFR Part 11 compliance was not implemented. Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com
At MS Remedies Inc. we perform a thorough CSV Audit periodically or annually to check the compliance status of Validated and Non Validated GxP System. MS Remedies Inc. will conduct the CSV Audit and generate a CSV Audit report along with mitigating steps and procedures. We can also help customers to close on compliance gaps. Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com
At MS Remedies Inc. we perform GxP Risk Assessment and Control Mitigation as part of CSV end to end validation services. If GxP Controls were not implemented or found missing during CSV audit, we perform robust risk assessment and apply effective control mitigation strategy. MS Remedies Inc. has a robust GxP Risk Assessment Tool to enable, track and incorporate GxP Control Requirement in the GxP System. Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com
At MS Remedies Inc. we offer Validation Testing Services as a part of CSV end to end services or a separate service and can also be executed 100% offshore. MS Remedies Inc. offer complete validation testing services including generation of Master Plan, Protocol, Test Scrips, Report etc. as an independent service or provide resources with the relevant CSV expertise to execute validation testing of GxP system and ensure objective evidence in form of proper documented evidence adhering to Good Testing and Good Documentation Practices (GDPs). Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com
At MS Remedies Inc. we offer Quality Assurance (QA) Review service as an independent service to review of all Validation deliverables. QA Review service can also be offered during Validation Testing with independence of Review maintained if MS Remedies Inc. is also performing Validation Testing Services. Our QA review team has excellent industrial experience and expertise in providing oversight and recommendation. Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com
The constantly evolving industry demands continuous product innovation, cost control and compliance to meet the various regulatory requirement. Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com