Life Sciences Systems

GXP regulations have imposed software testing and Quality Assurance onto the Life Sciences sector, effecting medical devices producers, biotechnology companies, pharmaceutical R&D and manufacturing companies.

Tescom’s risk-based approach and gap analysis determine the validation activities and improvements required for the optimal effectiveness of each software tool or computerized system that is used during the research, development, manufacturing, storage, testing, maintenance and distribution processes. Among the solutions Tescom providers to the Pharmaceutical industry are:

Developing a Software Validation Master Plan and Policy
Assessing compliance with 21 CFR 11 (GAP analysis and remediation action plan)
Producing Validation Documentation: SRS, SDS, STP (IQ, OQ, PQ)
Creating SOPs, Calibration, Traceability Matrices, Audit Trails
Software Vendor Site Audits
Execution of Testing (Manual / Automated)
Submission Assistance – 510(k), NDA, ANDA, PMA
Assisting with Part 11 Process and Qualification for Vendors

Our policy for adherence to FDA Guidelines on Software Validation also covers the following:

Policy principles
Classification according to criticality
Classification according to product type
Definition of Levels of Concern (LOC)
Validation activities per LOC
Testing failures
Revalidation Criteria

What life sciences systems do we test?

Quality Control Laboratory systems
R&D Laboratory systems
Manufacturing systems
Pharmaceutical systems
Biotechnology systems
Medical Devices systems
Clinical systems