What is the MDSAP program?
In Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) began development of a Medical Device Single Audit Program (MDSAP). MDSAP allows approved auditing organizations to conduct a single regulatory audit of a medical device manufacturer. This single audit expands the scope of the audit to previously unaudited areas of large organizations, standardizes a consistent auditing model, and replaces as many as five separate . It also satisfies the regulatory requirements of the authorities participating in the program – even ISO 13485:2016. MDSAP focuses on defined and linked processes and is based on requirements for risk management. The goals of MDSAP are:
to improve audit effectiveness and the influence the audit can have on outcomes that improve patient safety, and
to reduce the resource demands on both regulatory bodies and auditees in organizations having to comply with a variety of global standards and .
Life sciences organizations, including pharmaceuticals, and medical device manufacturers, constantly look for ways to reduce risk, increase patient safety, and achieve operational excellence. To be successful in these three areas, pharmaceutical and medical device manufacturing companies need to have robust management systems in place. This is even more critical than in other industries where the breadth of regulatory requirements is not as vast.
Transforming their QMS to the cloud can help them achieve these strategic objectives. Along this digital transformation journey, software validation can be a challenge with varying degrees of intricacy across organizations. Causes can range from lack of experience and expertise to the complexity of internal and external stakeholders involved. Ultimately, no one wants to receive a 483 from the FDA due to noncompliance with 21 CFR 11, which will put an organization in a bind and ultimately impact patient safety.
As pharmaceuticals and medical device manufacturers look … Read more...