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Quality Systems Development, Audits and Gap Assessments

NON-CONFORMANCE

Non-conformance (NC) management is integral to both FDA and ISO guidances regarding product quality. A product’s quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved to demonstrate processes are in control and predictable. NC management provides a system for managing unanticipated excursions from the expected process as a precursor to an effective CAPA system. Pharmatech has developed and implemented tailored NC systems which are designed to focus your NC system on value added investigations, ensuring your quality and technical staff are concentrating on only the critical few issues which are important to your company’s success and are true to your compliance philosophy.

CORRECTIVE AND PREVENTATIVE ACTION (CAPA)

Poorly structured CAPA programs account for a large percentage of the industry’s regulatory observations. Understanding the proper structure for developing or administering an effective CAPA program is an important component to ensuring overall compliance. Whether your needs are developing the structure and tools to effectively manage your CAPA program or evaluation and resolution of existing CAPA investigations, our experienced team of quality and technical personnel can assist.

COMPLAINT MANAGEMENT

Complaint Management is a critical link between your product’s performance in the field and system design. Today’s regulatory environment requires a clear linkage and demonstrable evidence that field complaints are being addressed as a part of your CAPA program. Pharmatech’s technical and quality professionals have many years of experience in designing, administering and assessing your complaint management system to ensure compliance.

CHANGE CONTROL

Your Change Control system is your primary means of ensuring your quality system’s integrity. Often Change Control systems lack the necessary definition and structure to become effective tools for managing the necessary improvement required to keep your business moving forward. The result is a slow, ineffective system which incentivizes many to avoid rather than embrace improvement.

Pharmatech’s quality and technical professionals have a strong understanding of what it takes to make your Change Control system effective again.

SUPPLIER QUALITY

As the marketplace begins to explore the emerging markets, Supplier Quality has never been more important. Pharmatech’s team of professionals has the expertise to select, evaluate, qualify and monitor the quality of materials and services provided by your suppliers in order to ensure supply chain integrity and supplier quality.

GxP COMPLIANCE, AUDIT AND GAP ANALYSES

The ability to create a quality management system (QMS) which is both compliant and effective without being onerous requires strong insight into both the drug development and compliance processes. Our end-to-end expertise allows us to develop systems which will withstand regulatory scrutiny without adding unnecessary overhead or compliance risk to your operation. Pharmatech’s quality and technical teams are well versed in the details of designing and implementing GxP systems. Whether your needs are GLP, GDP, GEP, GMP or GCP we have the expertise to design, evaluate or remediate your GxP system. Unlike other consultancies our experts will work with your team to identify deficiencies in your current QMS, then recommend solutions which will fit the capabilities of your organization, including training your team on the fundamental basis for each QMS.

DATA INTEGRITY, GDPR, HIPAA, GxP IT, INFOSEC

The role of electronic data management has become a critical focus in the Life Sciences Industry. Ensuring that your organization is in compliance with all legally mandated privacy requirements while ensuring the integrity of data while at rest, in use and during transport, can be a complex technical and compliance challenge. The consequences of non-compliance in today’s regulated market could represent a very large risk to your company’s bottom line. Our experts are thought leaders with decades of experience who have the knowledge and insight to identify gaps in your organization’s infrastructure, systems, networks, and privacy and security program.  They will recommend practical and implementable solutions to manage your risks. In an information and data management landscape which is constantly evolving, we have the technical knowledge, the business operation expertise, and the track record to address your compliance requirements.