GMP Validation and
Enjoy a 100% customer satisfaction, or money back of your investment guaranteed on 30 days.
Providing Consulting Services in Puerto Rico
and worldwide remotely, since 1996.
We can help you with every GMP need.
Grow with confidence, outsourcing the best GMP Validation and Regulatory Compliance services.
“Validation is the establishment of documentary evidence which provide a high degree assurance of specified process will consistently produce the product meeting with predetermined specification and quality attributes.”
"A written plan describing the process to be validated, including production equipment and how validation will be conducted."
"The user requirement(s) specification (URS) is a document usually used in computer system validation that specifies what the user expects the software to be able to do."
"Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer recommendations are suitably considered."
"Establishing confidence that process equipment and ancillary systems operate correctly within their specified limits consistently and dependably."
"Establishing confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible."
"Establishing by objective evidence that a process constantly produces a result or product meeting its predetermined specifications."
We offer a wide range of professional services in the GMP validation engineering and regulatory compliance field. We can prepare validation master plan, user requirements, design specifications, installation, operational and performance qualification. In addition, we can prepare traceability matrix, gap analysis, risk assessments, system compliance plans and other regulatory compliance documents. Bring us the opportunity to help you.
Computer System Validation
The quality of your product or service depends on the capability of the systems that support your processes. Therefore, to successfully comply with the GMP regulatory agencies, you must ensure that your equipment work in accordance with the manufacturer’s design specifications. We rely on the most highly qualified personnel to help you reach this goal.
Bring us the opportunity to help you.
GMP Project Management & Six Sigma Black Belt Tool
We have very strong experience managing projects using Microsoft Project to define the tasks, schedules, milestones and other project descriptions. Also, we master Minitab and other statistical analyses applications to perform: ANOVA Analysis of Variances, DOE, T-Tests, F-Tests, Central Tendency, Variation, Correlation, Regression, Linearity, Capability Analysis, Taguchi Method and many others. Bring us the opportunity to help you.
CAPA and Regulatory Compliance Services
CAPA investigations: We can help you to prepare the incident investigation reporting for the FDA regulated industries. In addition, we have strong experience supporting FDA audit, cGMP’s, in-coming, vendor certification, computer validation 21 CFR part 210, 211, 600 or 820. Moreover, we have extensive experience in the preparation of robust investigations, Change Control, Risk assessments, 21 CFR part 11 gap analysis, system classification and system compliance plans.
GxP Training Services
We can provide different kind of training and assessments to support and improve your Quality Systems including GMP Validation and Regulatory Compliance. The most popular training are: cGMP, GDP, GLP, ISO13485, ISO14644, Lean manufacturing, Validation, CAPA investigations, etc.
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GMP VALIDATION AND REGULATORY COMPLIANCE SERVICES FOR
Medical Devices Companies
Validation Instrument Leasing with configuration, setup and preparation of reports included.
If you need talent management and temporary staffing services in Puerto Rico or worldwide, contact us.
We can find the best professional resources for your company needs.
The best GMP Validation Regulatory Compliance Services in Puerto Rico. Best outsourcing validation engineering companies in Puerto Rico.
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