Quality Management Systems (QMS)

In life sciences, QMS is crucial. It makes compliance with regulatory standards achievable, improves operational efficiency and pushes for continuous improvement. In the realm of the life sciences we provide expert consulting sevices on quality management systems (QMS).

Why Choose BioBoston Consulting?

Industry-Specific Experience

We know the peculiar challenges industry and different national regulatory systems pose, bringing this experience to bear on every solution we build. Our team has worked extensively with drug, biotech and medical device companies.

Compliance with Global Standards

Our QMS is designed to meet the latest regulatory requirements so you don’t have to worry about it. We ensure that our system is in alignment with global standards as dictated not only by the FDA but also by EMA, ISO 13485, etc. The result is a solution that meets current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).

Customized QMS Solutions

We understand your company’s individual needs. Whether you ‘re starting from scratch with a QMS or bringing one up-to-date, our customized services make your quality processes more effective, save on risk exposure, and increase operational efficiency wherever possible.

The Pursuit of Continuous Improvement

Our QMS is different. It’s not just about keeping up with regulatory changes, it’s about ongoing improvement. We guide you to build a quality environment where products can be made more secure and errors minimized—all to enhance business performance as well.

Systems That Are Scaled And Flexible

What we give you are not rigid systems which will not grow with the company’s needs. In response to the requirements of each individual company, our QMS services are designed to be scalable and flexible.

Our QMS Services Include:

Design And Implementation Of Quality Management Systems (QMS)

Design and carry out a tailor-made QMS framework that conforms to government demands and matches corporate goals as a means of investment. Now you have a well-equipped operation at BioBoston Consulting that does everything for you.

QMS Audits and Gap Assessments

Why are you spending so much time and effort preparing for an audit, when you could use that valuable resource to build a much-improved home for your future?

Document Control and Management

Create systems that enable accurate records, up-to-date and in compliance with regulatory requirements.

Training and SOP Development

From drafting Standard Operating Procedures (SOPs) that ensure normal operation, based on company values, to organizing personnel for labor conflicts–whatever your needs are, BioBoston Consulting can meet them.

CAPA (Corrective and Preventive Action) Management

Put into operation a succession of efficient CAPA procedures for non-conformances: sync nearly everything else with your strategic business imperatives.

Risk Management and Compliance Monitoring

Regular monitoring and risk assessments for your QMS provide you with the peace of mind that especially in today’s regulatory intensive environment, not only will it be up-to-date but also evocative.

BioBoston Quality and Compliance

Our Quality Management Systems progressively turn scientific enterprises into businesses, institutionalize operational efficiency, efficiency is assured and with a constant eye to quality.

Contact Us Today

Please call for a consultation with BioBoston Consulting on your Quality Management System requirements.