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Our Services

Providing Independent quality and regulatory consulting services for biotech, medical devices, pharmaceutical, and consumer products specializing in remediation efforts of quality systems associated with corrections, improvements, validations, training, coaching, CAPA files/records, design controls, risk management, manufacturing, and much more. Provide expertise advice and guidance following audit observations complimented by a proactive gap analysis and permanent solutions.  
CAPA Remediaiton 

CAPA stands for Corrective Action Preventive Action (CAPA) is the result of a US FDA requirement, FDA 21 CFR 820.100. We can help with:

  • Assess current CAPA System.

  • Review and recommend revisions and updates to any compliance gaps.

  • Develop Quality Plans and CAPA Plans to address compliance gaps. 

  • Review Root Cause Analysis work is risk based and effectiveness checks are appropriate. 

  • Provide coaching, mentoring and training

  • Will even interface with regulatory bodies regarding quality compliance issues.

  • Enhancement or total implementation of a new CAPA System to be compliant with most current regulations. 

Production & Process Controls

An effective quality system takes a total systems approach to satisfy safety, effectiveness, and performance requirements govern by current Good Manufacturing Practice (cGMP) FDA 21 CFR 820.70 the facilities and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all medical devices.

  • Process characterization.

  • Create instructions, SOPs, and training regimens.

  • Monitoring and control of process parameters.

  • Supplier Controls

  • Identifying and controlling the process and acceptance criteria.

  • Controls for incoming raw materials to storage, distribution, installation, and servicing.

Equipment & Facility Controls

Whether you are building a new facility / expansion or faced with compliance deficiencies to your existing manufacturing operations / equipment, facility, installing new capital equipment; re-validating existing equipment / utilities we can tailor and develop an appropriate validation strategy & validation master plan to help with:

  • Remediation of quality system deficiencies related to your manufacturing process (cleanrooms), equipment, or facility.

  • Provide expert guidance from design qualification, user requirement (URS) definition through factory (FAT) / site acceptance (SAT) and through commissioning (Testing / verification) and qualification (IQ, OQ, PQ).

  • Validation of Software and computer systems.

Records, Documents & Change Controls

Document control is an essential element of an effective quality system. Documents demonstrate that the systems and controls used to ensure that finished devices meet specification have been effectively implemented. Any alteration of an existing approved document is considered a change to the document. We can help with ensuring that:

  • All documents have been reviewed for adequacy and approved prior to distribution.

  • All document changes have been reviewed and approved prior to distribution.

  • Adequate support systems are in place such as management responsibility, training, purchasing control, calibration control and document control.

  • Ensure Quality Systems procedures communicate desired outcomes, clarify methods, and ensure consistency.

  • Ensure DHF and DMR records are compromised with the correct and adequate information as it relates to you products. 

  • Ensure documents are readable, spelling errors, typos, format are correct. 

  • Ensure that distribution controls of documents ares simple, visible, and that only the right documents are approved, released and used.

 

Materials Controls

It is the manufacturers responsibility to have the proper controls in place for every step of their global supply chain to ensure that all components and services supplied for their products follow current Good Manufacturing Practices (cGMP) per 21 CFR Part 820. We can help:

  • Assess the capability of suppliers and/or vendors.

  • Ensure incoming inspections & tests are meeting acceptance requirements.

  • Ensure that the components purchase are safe and effective pursuant to purchasing controls. 

  • Assess and determine by auditing if the current quality system is adequate for proper control of all components or services rendered.

  • Evaluate if the proper verification and/or assessment tools such as a change control and CAPA are effective. 

  • Review and assessment of supplier agreements, purchasing agreements, specific product requirements, and related activities.

  • Review and assessment of the Risk Management Process for identification of high risk components and suppliers.

  • Development of supplier Quality Agreement (SQAs), if needed, to establish clear responsibilities between supplier and customer. 

  • Review and assessment of design transfer requirements per established design controls.

Design Controls 

Design controls demonstrate our medical devices are safe, effective, and meet the indications for use. These design controls (regulations) are regulated by agencies throughout the world such as FDA (USA), Europe Competent Authority (Europe), Health Canada (Canada), TGA (Australia), NMPA (China) and so on. We can help with:

  • Assessing you quality system to ensure the processes and procedure for design controls has been established and adequate. 

  • Gap analysis of the quality system against the different medical device regulations to identify any compliance gaps and provide corrections. 

  • Review all design control documentation and records (DHFs) per your product development process. 

  • Integration assessment of Risk Management into your design control process. 

  • Review of the design transfer activities to ensure readiness for production. 

  • Development and/or update design control procedures to demonstrate compliance to the different design elements such as Inputs, Outputs, Reviews, Verification, validations, transfers and changes. (Software Life-cycle where is applies)

  • Evaluation or Analysis of your Software as a Medical Device (SaMD) or software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.  

  • Development or assistance with 510K preparation and submission. (PMA will applicable)

  • Provide coaching, mentoring and training.

 

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