We are Hiring

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“Cost is more important than quality but quality is the
best way to reduce cost”
- Genichi Taguchi
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“Improve quality, you automatically improve productivity”
- W. Edwards Deming
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“Quality control is applicable to any kind of enterprise.
In fact, It must be applied in every enterprise”
- Kaoru Ishikawa

Who we are

Welcome to Mindworks Engineering Services  LLC. is a leading provider of engineering consulting services to our clients in the pharmaceutical, and medical device industries.  We believe each project and each company is unique and so we take pride in tailoring our services to the custom requirements of our clients.

To better assist different staffing needs, we provide On-site & Off-site Consulting services, Contingency Recruiting, Contract Staffing for our clients. We specialize in the areas of GxP compliance, Quality Systems, Risk Management, Design and Development, IT Systems and Validations in the regulated industry environment. We are proud of our talented professionals and the major contributions, they make to our clients’ successes on mission critical projects.

Our consultant’s proficiency with 21 CFR part 820 and experiences in numerous scenarios guided several of our clients to success by providing timely and efficient solutions. We specialize in bringing long term solutions as per latest FDA observations and warning letters. Mindworks Engineering Services  LLC. provides experienced candidates with consulting services in the different areas like:

What we do

Design and Development

Validation of Processes

Risk Management

Product Software

Identification & Tractability​

Clinical Data Management

Quality Audits

Device Labeling

Usability Engineering

Regulatory Affairs

How we do

Clinical Data Management

From database build to database lock, clinical data management (CDM), the process of collecting, cleaning, and managing subject and/or trial data in compliance with regulatory standards, is a crucial component of any clinical trial. When done efficiently, CDM of retina trials leads to the generation of statistically sound data and accelerates the drug development process. Our Clinical Data management team is thinking about secure and precise assortment and cleaning the information from each evaluation. This cautious instrument gives an incentive during the study plan zones, information region, information clean up, coding of terms, information changes, revealing, steady web access, review trail, and charge of the clinical data for assessment purposes.

Regulatory Affairs

Regulatory affairs play a vital role in any life science company as ensures the safe and effective making of healthcare products, including pharmaceuticals and medical devices. Companies responsible for the creating, manufacturing and marketing of medical products have a duty to certify that the products they produce are fit for purpose and make a valuable contribution to health and wellbeing.

It is the responsibility of our regulatory affairs professionals to keep abreast of the ever-changing legislation and guidelines in which their company operates in as they are required to give strategic advice on the legal and scientific requirements that products must meet. A regulatory affairs professional will be in charge of collecting, collating and evaluating data as well as being responsible for registration documents and carrying out any necessary negotiations that affect a product’s market authorization.

Regulatory affairs department will often be involved in the development of product marketing concepts and is commonly required to approve packaging and advertising before a product goes to market.

Quality & GxP Compliances

Compliance keeps operations running smoothly and makes sure everyone follows proper procedures and understands expectations. Healthcare compliance is about providing safe, high-quality patient care. Complying with industry standards and regulations helps healthcare organizations continue to improve the quality of care.
Mindworks Engineering Services LLC. ensures your business with quality control measures to keep your business exceptionally productive. We put away money, time and exploration to furnish you with the best administrations accessible to push your business into the following degree of achievement.
We recognize the requirements of the regulated industry and brew safety and accountability first culture in our firm. This culture is also translated to our consultants and contractors and is implemented everyday in several forms of GxP practices. Our expertise is included but not limited to CGMP(Current Good Manufacturing Practices), GDP (Good Documentation Practices), GLP(Good Laboratory Practices).
We handpick our consultants and contractors to put quality first in all scenarios. This positive culture and training makes us excel in providing efficient solutions and service in several elements of the quality system such as but not limited to Management: Quality Plan, Quality Manual, Corporate policies.
Corrective & Preventive Actions: Project management, Investigation, Implementation, Verification of Effectiveness (VOE), 21CFR 820.100 compliance. Production and Process Controls: Develop Standard Operating Instructions (SOP), Process monitoring, Process Failure Mode Effects Analysis(PFMEA), Inspection plans, Training plans and Process Monitoring. Test method development, Measurement and System Analysis (MSA) with 21 CFR 820.72 compliance.

Validation

Validation is the process of creating an evidence trail to show that an action, process or system leads to a consistent and reproducible result. This ‘result’ is typically either taking a measurement or assessing product quality.
Our Validation Engineers rigorously test and pre-test the systems used to manufacture products. They inspect, measure, analyze, audit, calibrate and test the instrumentation, equipment, machines and procedures. They have expertise in performing Capability Analysis, Design of Experiments(DOE), Installation Qualification (IQ), Operation and Performance Qualifications (OQ/PQ) with 21 CFR 820.75 compliance. Automated system validations based on Good Automated Manufacturing Practices (GAMP IV and V) and 21 CFR part 11 guidance.
Equipment used, produce a defect-free consistent result. This ensures that the product is consistently of the highest quality. MINDSWORKS ENGINEERING SERVICES LLC provides experienced candidates for different roles like Process Validation, Cleaning Validation, Computer Systems Validation, Equipment Validation.

Contact us

Address

30 N Gould St Sheridan, WY 82801

Phone

+1 (307) 200-8151

Email

sales@mindworkss.com