We are certified partner of Microsoft and Microsoft Dynamics NAV reseller wherein we have the ability to sell, customize, implement, maintain, support and upgrade your Microsoft Dynamics NAV ERP. With the great service we provide, we want to build good relationships with every client we serve and develop effective strategies that will deliver solutions which will best fit the business requirements of our customers.
Our team of Dynamics NAV experts can provide you the integrated solutions that are based on Microsoft Dynamics NAV that can truly help transform your business. We can ensure you that you are partnering with the trusted Solution Company that has already proven to increase the productivity of several customers.
We have been successfully implementing the solutions based on Microsoft Dynamics NAV that can hone the best practices and methodologies. With the right knowledge we have, our team can help you reduce your cost for your Dynamics NAV platform and avoid the risk that is connected to the Implementations of ERP.
Medical Device Development and Manufacturing
Procal’ s Research and Development Engineers are very creative and have been involved in development of various new design concepts for our medical device clients. Our engineers have been responsible for implementing lean and six sigma approaches in our client’s manufacturing facilities. They also work on continuous process improvements at our client’s site.
Product Development and Manufacturing Services Provided:
Design engineers (CAD, Solid Works, Pro-E)
Kaizen/ Continuous Improvement
Statistical Process Control (SPC)
Design of Experiments (DOE)
Quality System Implementation
All medical device-manufacturing companies in the US need to follow good manufacturing practices (GMP). Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation (QSR) of the 21 Code of Federal Regulations (CFR) Part 820. The FDA is responsible for monitoring the QSR compliance of all U.S. medical device companies.
Procal’ s Quality Team will provide valuable and informed insight for developing and implementing their client’s comprehensive quality plan. We will also advise and assist in developing and maintaining quality management systems and continuous improvement initiatives.
Quality System Services Provided:
- GxP Training and Audits
- Quality Agreement Preparation
- Authoring Quality Manuals and Procedures (SOP)
- Preparing Work Instructions and Process Maps
- Device Master Records & Device History Records
- Design History Files (DHF)
- CAPA program development and implementation
- Remediating compliance Support (Warning Letters, Complete Response Letters and Consent Decrees)
- Risk Assessment
- Validation Approach
Pharmaceutical Manufacturing and Validation
Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. A validated process is one, which has been demonstrated to provide a high degree of assurance that uniform batches will be produced, that meet the required specifications and has therefore been formally approved. Validation does not improve processes but confirms that the processes have been properly developed and are under controls. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it. Thus, validation is an integral part of quality assurance.
Procal Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonization (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
We expertise in:
- Equipment validation
- Facilities validation
- HVAC system validation
- Cleaning validation
- Process validation
- Analytical method validation
- Computer System Validation
- Packaging Validation
ISO 14971:2007 or EN ISO 14971:2012 is an international standard for risk management of medical devices. The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices. The purpose of ISO 14971 is to establish, document and maintain a risk management process to:
Review the intended use of the medical device.
Identify hazards and estimate the probability that harm might occur.
Estimate the severity of each hazard and evaluate the associated risks.
Control those risks and monitor the effectiveness of the controls put in place.
Risk Assessment Services Provided:
Process Failure Mode Effects Analysis (PFMEA)
Design Failure Mode Effects Analysis (DFMEA)
Development of procedures for handling Risk
Action items and deadlines
Reduce the risk
Procal technical operation team specializes in providing regulatory consulting services to their clients who are medical device manufacturers. We have a dedicated team working with our clients in regulatory strategy, preparation of FDA submissions, product manufacturing and testing, clinical trials set up and data collection and maintaining quality compliance.
Regulatory Services Provided:
FDA Regulatory Compliance Strategy
Premarketing Clearance 510(k) Submissions
Device Classifications and Product Listings
FDA Biocompatibility Requirements
Mock FDA Audits
Warning letter (Form 483) Responses & Activities
International Import/Export Issues
Regulations for packaging and labeling
Procal strives to serve its clients with honesty and integrity while providing them with the best Business and Technology solutions for their business needs. In doing so, we evoke teamwork and client collaboration, along with hard work and accountability, to earn the privilege to be “Your Partner in Business solutions”.