BioAssist offers a variety of services that will support your quality system needs. From strategic planning to implementation to training and support, our associates have the depth and breadth of experience to make an immediate, positive impact on your quality system at any stage of the product development lifecycle.

Please click on the links on the left to learn more about each of our services. For a list of services we offer by pharmaceutical, medical device or biologics industry, please click here.


Regulatory and Compliance Strategy
Regulatory planning requires much more than determining product approval strategy. Regulatory professional must carefully balance compliance and business initiatives and be prepared to effectively manage difficult issues relating to product quality, risk and liability. BioAssist’s comprehensive approach establishes a firm foundation for compliance by establishing rapport with inspection agencies, focusing on management commitment to quality, and providing timely, practical answers to quality and compliance questions. We understand the significance and application of risk management to the development of effective corrective action following inspections, audits, or enforcement actions. We identify systemic problems and develop comprehensive plans that address root causes while supporting business objectives. Our associates are former FDA inspectors who are comfortable interfacing with FDA officials to resolve issues. We can develop plans and strategy to effectively handle:

  • FDA inspections
  • FD-483s and Warning Letters
  • FDA enforcement actions
  • Recalls
21 CFR Part 11: The Regulation of Electronic Records; Electronic Signatures

A significant increase in inspectional observations of 21 CFR Part 11 deficiencies by the FDA makes 21 CFR Part 11 an area of compliance that cannot be ignored. Click here to learn more about this emerging area of concern and how BioAssist can help you with your 21 CFR Part 11 issues...

Auditing
Auditing your quality system yields benefits beyond meeting FDA requirements. It assures that your quality system is providing the information you need to manage product quality, personnel performance, and production efficiency – information essential to business success. BioAssist can enhance the results of your auditing efforts. Our associates are former FDA investigators who can help you meet your internal auditing obligations, validate the results of your internal auditors, give you an objective viewpoint, and prepare your organization for inspection by regulatory agencies. We offer the following auditing services:

  • Mock FDA GxP inspections
  • Mock Pre-Approval Inspection (PAI)
  • Quality System/GMP Audits using FDA QSIT Techniques
  • Routine internal audits
  • Supplier QA audits

Gap Analysis
BioAssist can help your organization identify "gaps" between current practice and a pre-defined set of regulations, guidance documents, and "best practice" industry standards. GAP Analysis reveals systemic issues and is often our recommended "first step" in implementing corrective action in response to FDA inspections or FDA enforcement actions. We have developed a specific technique for conducting Gap Analysis which includes an inventory of systems to be analyzed, organization of a pre-defined set of requirements compiled into comprehensible Gap Analysis worksheets, questions formatted for easy "Yes/No" responses, a scoring system to quantify results, and proprietary techniques to estimate relative risk associated with each system under review in order to facilitate and prioritize corrective action. Areas that are commonly analyzed include:

  • 21 CFR Part 11, Electronic Records and Electronic Signatures
  • Process Controls
  • Validation Programs
  • Computerized Systems and Software QA
  • Design Controls
  • CAPA

Quality System Development
A solid quality system is the foundation for product safety and regulatory compliance. Quality system documentation provides the crucial "first impression" of your organization during inspections and audits. BioAssist can:

  • Fully develop all or part of your quality system.
  • Assist your staff in writing quality system policies, procedures, and work instructions.
  • Review and recommend improvements to your existing policies and procedures.
  • Develop documentation tools such as templates and forms to support GxP record keeping.
  • Develop training programs to support your quality system.

We utilize process and information mapping techniques that assure your documentation reflects actual practice and is easy to understand. Flow charts, step-by-step instruction tables, graphic content, and careful organization ensure that your SOPs, Work Instructions, Batch records, or Travelers are easily understood by operators who use the documents daily as well as external auditors.

Validation Services
Facilities, utilities, environmental controls, test methods, equipment, processes, packaging, shipping, cleaning, computer systems, application software, spreadsheets, and databases that affect or contribute to product quality are all subject to qualification or validation. How do you determine what validation requirements apply to a specific system or process? How do you validate a manufacturing process, computer system, or software application? If a process doesn't require validation, how do you document this decision and its justification? What documentation does the FDA expect? Where do you start? BioAssist has the answers. Our services include:

  • Master Validation Planning
  • Development of Validation Policies, Procedures, and Templates
  • Managing Plant Relocation and revalidation
  • Protocol Development
  • Computerized System and Software Validation

Training
BioAssist provides training in a wide variety of FDA and GxP topics. Our associates have trained thousands of professionals representing every major pharmaceutical, device, and biotechnology company in the U.S. We have trained engineers, QA staff, regulatory professionals, senior management, and production personnel in ten countries (and counting). In conjunction with EduNeering, Inc., Rebecca D. Fuller, Principal of BioAssist, helped to develop computer interactive training programs currently used to train FDA investigators and employees of several leading FDA-regulated companies. In addition to providing workshops, seminars, and training sessions, we can customize training materials, programs, and train-the-trainer sessions based on your specific operations, procedures, or programs. We provide on-site training or handle all the arrangements for a professional off-site seminar or workshop customized for your business needs. Topics include:

  • Good Manufacturing Practices (GMP) for drugs, cosmetics, and biologics
  • Quality System Regulation (QS Reg) for Medical Devices
  • Good Laboratory Practice (GLP)
  • Good Clinical Practice (GCP)
  • Process Validation
  • Design Control
  • CAPA (including Complaint Management, MDR, and Failure Investigations)
  • 21 CFR Part 11- Electronic Records, Electronic Signatures
  • Software Validation
  • Cleaning Validation
  • Document and Change Control Management

Product Development - Medical Devices
A strong design control program is an FDA requirement for medical devices and is a vital tool in managing product development activities for any industry. Product development assistance available from BioAssist includes:

  • Conducting preliminary literature searches
  • Writing design plans
  • Establishing and maintaining design history files to assure regulatory compliance,
  • Developing or auditing design verification and design validation protocols,
  • Assisting in the management of design transfer, process development, and product scale-up,
  • Participating in design reviews as an independent observer