Comply

Comply develops off-the-shelf specialized software products that provide a complete and integrated solution for the special Quality Management needs of the pharmaceutical, medical device and biotechnology industries.

Comply helps ensure that your organization complies with regulatory requirements of computerized systems and improves your operations by providing expert consulting and specialized information systems.

Services & Products:

Comply is a leader in pharmaceutical regulatory compliance and a developer of unique, specialized Information Systems aimed at Pharmaceutical, Biotechnology, Medical Devices and other highly regulated industries. Building on years of experience serving this community, we understand our customer’s ambitions, constraints and the regulatory demands they face.

We provide the business community with quality business information solutions, professional System Validation Service, and unparalleled Customer Service through the application of the highest levels of System Development standards and Quality Control principles.

Our portfolio of services and products makes it easy for your organization to meet regulatory requirements while keeping costs under control . Below are some of the services and products we offer:

Comply’s Quality Management products

• Skyline - Management and analysis of manufacturing, environmental monitoring and stability processes

• Origin - Integrated solution for the management of the Documentation Center, employee training and Change Control.

• React - Process management of deviations, audits, customer complaints, adverse events, workplace safety and CAPA.

• Advance - Planning and control of validations, calibrations and maintenance activities.

• VerC - Managing information related to inventory and to the life cycle of computerized systems.

• The Quality Portal - Comply’s user friendly portal interface through which all products are easily accessed and managed

Each software package has been developed under the highest industry standards, is Part 11 compliant and includes a validation kit.

Comply’s Expert Services

• Validation of Computerized Systems

• Validation of Information Technology infrastructure

• FDA 21 CFR Part 11 compliance

• Excel applications’ development and validation

• Vendor audits

• Writing policies and procedures