Pharma & Life Sciences

Pharmaceutical, medical technology and life sciences companies face more pressure than ever to increase revenue, accelerate innovation, maintain product quality, and achieve cost savings. In parallel, they foster innovation as the basis for new products.

Failing to manage the exploding quantity of data and documents associated with the different activities can sabotage an organisation’s efforts to achieve its operating objectives and regulatory compliance responsibilities.

Information technology should play a crucial supporting role within companies, yet many organisations continue to rely on departmental solutions that create barriers to rapid information exchange, make content approval and distribution more labour intensive, increase the total cost of ownership, and compromise regulatory compliance.

In collaboration with our partners, ELCA delivers services and solutions that support the validation of the solution and the management of data and documents along the value chain. This helps to enable innovation, operational excellence, product safety, manufacturing consistency, and regulatory compliance.

From our portfolio

Portfolio
LSQM (Life Science Quality and Manufacturing)
ELCA offers a turnkey solution guaranteeing rapid implementation conforming to regulations: Life Science Quality and Manufacturing (LSQM), in partnership with EMC. LSQM is preconfigured to respond to CGMP needs as well as specific requirements for electronic signatures according to regulations set out by the FDA (CFR, title 21, part 11) and EMA (EudraLex, vol. 4, annex 11). The solution is preconfigured for all types of documents, workflows, roles and metadata necessary for the implementation of good practice in the area of GMP documentation.

ELCA offers a turnkey solution guaranteeing rapid implementation conforming to regulations: Life Science Quality and Manufacturing (LSQM), in partnership with EMC. LSQM is preconfigured to respond to CGMP needs as well as specific requirements for electronic signatures according to regulations set out by the FDA (CFR, title 21, part 11) and EMA (EudraLex, vol. 4, annex 11). The solution is preconfigured for all types of documents, workflows, roles and metadata necessary for the implementation of good practice in the area of GMP documentation.

All the Portfolio

References

Edwards Life Sciences Alcon Pharmaceuticals Lonza Medtronic Merck Serono Novartis Pharma Serono
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